Sample preparation container and method

A system and method for preparing and collecting samples for analyte testing. The system can include a sample preparation system and a sample collection system coupled to the sample preparation system. The sample preparation system can include at least one of a deformable self-supporting receptacle comprising a reservoir and a freestanding receptacle comprising a reservoir. The reservoir can be adapted to contain a liquid composition. The sample collection system can be positioned in fluid communication with a reservoir of the sample preparation system, and can be adapted to capture an analyte of interest. The method can include providing a fluid path defined at least partially by the sample preparation system and the sample collection system, positioning the liquid composition in a reservoir of the sample preparation system, and moving at least a portion of the liquid composition in the fluid path to the sample collection system.

BACKGROUND

In a variety of applications, food and non-food sources may need to be tested for microorganisms (e.g., bacteria, viruses, fungi, spores, etc.) and/or other analytes of interest (e.g., toxins, allergens, hormones, etc.). For example, foods grown, purchased and consumed by the general population may contain or acquire microorganisms or other analytes, which can flourish or grow as a function of the environment in which they are located. This growth may lead to accelerated spoilage of the food product or to the proliferation of pathogenic organisms, which may produce toxins or multiply to infective doses. By way of further example, a variety of analytical methods can be performed on samples of non-food sources (e.g., groundwater, urine, etc.) to determine if the sample contains a particular analyte. For example, groundwater can be tested for a microorganism or a chemical toxin; and urine can be tested for a variety of diagnostic indicators to enable a diagnosis (e.g., diabetes, pregnancy, etc.).

SUMMARY

The present disclosure relates to a sample preparation and collection system and method, and particularly, to a sample preparation and collection system and method for analyte testing, the sample preparation and collection system comprising a sample preparation system and a sample collection system coupled to the sample preparation system that captures or collects an analyte of interest from a liquid composition, a filtrate thereof, or a sample taken from the liquid composition or the filtrate.

Some embodiments of the present disclosure provide a system for preparing and collecting samples for analyte testing. The system can include a sample preparation system comprising, and a sample collection system coupled to the sample preparation system. The sample preparation system can include a deformable self-supporting receptacle comprising a reservoir, and the reservoir can be adapted to contain a liquid composition comprising a source and a diluent. The sample collection system can be positioned in fluid communication with the reservoir of the sample preparation system, and the sample collection system can be adapted to capture an analyte of interest from the liquid composition.

Some embodiments of the present disclosure provide a system for preparing and collecting samples for analyte testing. The system can include a sample preparation system and a sample collection system coupled to the sample preparation system. The sample preparation system can include a freestanding receptacle comprising a reservoir, and the reservoir can be adapted to contain a liquid composition comprising a source and a diluent. The sample collection system can be positioned in fluid communication with the reservoir of the sample preparation system, and the sample collection system can be adapted to capture an analyte of interest from the liquid composition.

Some embodiments of the present disclosure provide a system for preparing and collecting samples for analyte testing. The system can include a sample preparation system and a sample collection system coupled to the sample preparation system. The sample preparation system can include a freestanding container comprising a first reservoir, a deformable self-supporting receptacle dimensioned to be received in the first reservoir of the freestanding container and comprising a second reservoir, and a lid adapted to be coupled to at least one of the freestanding container and the deformable self-supporting receptacle. The second reservoir can be adapted to contain a liquid composition comprising a source and a diluent. The sample collection system coupled can be positioned in fluid communication with the second reservoir of the sample preparation system, and the sample collection system can be adapted to capture an analyte of interest from the liquid composition.

Some embodiments of the present disclosure provide a method for preparing and collecting samples for analyte testing. The method can include providing a sample preparation system comprising a freestanding receptacle comprising a reservoir, and providing a sample collection system coupled to the sample preparation system. The sample collection system can be positioned in fluid communication with the reservoir of the freestanding receptacle, and the sample collection system can be adapted to capture an analyte of interest. The method can further include providing a liquid composition comprising a source and a diluent, and providing a fluid path defined at least partially by the sample preparation system and the sample collection system. The method can further include positioning the liquid composition in the reservoir of the freestanding receptacle, and moving at least a portion of the liquid composition in the fluid path to the sample collection system.

Some embodiments of the present disclosure provide a method for preparing and collecting samples for analyte testing. The method can include providing a sample preparation system comprising a deformable self-supporting receptacle comprising a reservoir, and providing a sample collection system coupled to the sample preparation system. The sample collection system can be positioned in fluid communication with the reservoir of the deformable self-supporting receptacle, and the sample collection system can be adapted to capture an analyte of interest. The method can further include providing a liquid composition comprising a source and a diluent, and providing a fluid path defined at least partially by the sample preparation system and the sample collection system. The method can further include positioning the liquid composition in the reservoir of the deformable self-supporting receptacle, and moving at least a portion of the liquid composition in the fluid path to the sample collection system.

Other features and aspects of the invention will become apparent by consideration of the detailed description and accompanying drawings.

DETAILED DESCRIPTION

Before any embodiments of the invention are explained in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the accompanying drawings. The invention is capable of other embodiments and of being practiced or of being carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including,” “comprising,” “containing,” or “having” and variations thereof herein is meant to encompass the items listed thereafter and equivalents thereof as well as additional items. Unless specified or limited otherwise, the terms “supported,” and “coupled” and variations thereof are used broadly and encompass both direct and indirect supports and couplings. It is to be understood that other embodiments may be utilized, and structural or logical changes may be made without departing from the scope of the present disclosure. Furthermore, terms such as “front,” “rear,” “top,” “bottom,” and the like are only used to describe elements as they relate to one another, but are in no way meant to recite specific orientations of the apparatus, to indicate or imply necessary or required orientations of the apparatus, or to specify how the invention described herein will be used, mounted, displayed, or positioned in use.

The present disclosure is generally directed to a system and method for preparing and collecting samples. The collected samples can be further concentrated, enriched, and/or analyzed for the presence or absence of a variety of analytes.

The term “source” is generally used to refer to the food or nonfood desired to be tested for analytes. The source can be a solid, a liquid, a semi-solid, a gelatinous material, and combinations thereof. In some embodiments, the source can be provided by a substrate that was used, for example, to collect the source from a surface of interest. In some embodiments, the liquid composition can include the substrate, which can be further broken apart (e.g., during an agitation or dissolution process) to enhance retrieval of the source and any analyte of interest. The surface of interest can include at least a portion of a variety of surfaces, including, but not limited to, walls (including doors), floors, ceilings, drains, refrigeration systems, ducts (e.g., airducts), vents, toilet seats, handles, doorknobs, handrails, bedrails (e.g., in a hospital), countertops, tabletops, eating surfaces (e.g., trays, dishes, etc.), working surfaces, equipment surfaces, clothing, etc., and combinations thereof. All or a portion of the source can be used in the sample preparation system and method. When a portion of the source is used, this can sometimes be referred to as a “sample” of the source. However, the term “sample” is generally used herein to refer to a volume or mass of material that is extracted from the sample preparation system for further analysis (e.g., detection of analytes).

The term “nonfood” is generally used to refer to sources of interest that do not fall within the definition of “food” and are generally not considered to be comestible. Examples of nonfood sources can include, but are not limited to, clinical samples, cell lysates, whole blood or a portion thereof (e.g., serum), other bodily fluids or secretions (e.g., saliva, sweat, sebum, urine), feces, cells, tissues, organs, biopsies, plant materials, wood, soil, sediment, medicines, cosmetics, dietary supplements (e.g., ginseng capsules), pharmaceuticals, fomites, other suitable non-comestible materials, and combinations thereof.

The term “fomite” is generally used to refer to an inanimate object or substrate capable of carrying infectious organisms and/or transferring them. Fomites can include, but are not limited to, cloths, mop heads, towels, sponges, wipes, eating utensils, coins, paper money, cell phones, clothing (including shoes), doorknobs, feminine products, diapers, etc., portions thereof, and combinations thereof.

The term “analyte” is generally used to refer to a substance to be detected (e.g., by a laboratory or field test). A source can be tested for the presence or absence of particular analytes or for quantitation of particular analytes. Such analytes can be present within a source (e.g., on the interior), or on the exterior (e.g., on the outer surface) of a source. Examples of analytes can include, but are not limited to, microorganisms, parasites (some of which are also microorganisms), biomolecules, chemicals (e.g. pesticides, antibiotics), metal ions (e.g. mercury ions, heavy metal ions), metal-ion-containing complexes (e.g., complexes comprising metal ions and organic ligands), and combinations thereof.

The term “microorganism” is generally used to refer to any prokaryotic or eukaryotic microscopic organism, including without limitation, one or more of bacteria (e.g., motile or vegetative, Gram positive or Gram negative), viruses (e.g., Norovirus, Norwalk virus, Rotavirus, Adenovirus, DNA viruses, RNA viruses, enveloped, non-enveloped, human immunodeficiency virus (HIV), human Papillomavirus (HPV), etc.), bacterial spores or endospores, algae, fungi (e.g., yeast, filamentous fungi, fungal spores), prions, mycoplasmas, and protozoa. In some cases, the microorganisms of particular interest are those that are pathogenic, and the term “pathogen” is used to refer to any pathogenic microorganism. Examples of pathogens can include, but are not limited to, members of the family Enterobacteriaceae, or members of the family Micrococaceae, or the generaStaphylococcusspp.,Streptococcus, spp.,Pseudomonasspp.,Enterococcusspp.,Salmonellaspp.,Legionellaspp.,Shigellaspp.,Yersiniaspp.,Enterobacterspp.,Escherichiaspp.,Bacillusspp.,Listeriaspp.,Campylobacterspp.,Acinetobacterspp.,Vibriospp.,Clostridiumspp., andCorynebacteriaspp. Particular examples of pathogens can include, but are not limited to,Escherichia coliincluding enterohemorrhagicE. colie.g., serotype O157:H7,Pseudomonas aeruginosa, Bacillus cereus, Bacillus anthracis, Salmonella enteritidis, Salmonella typhimurium, Listeria monocytogenes, Clostridium botulinum, Clostridium perfringens, Staphylococcus aureus, methicillin-resistantStaphylococcus aureus, Campylobacter jejuni, Yersinia enterocolitica, Vibrio vulnificus, Clostridium difficile, vancomycin-resistantEnterococcus, andEnterobactersakazakii. Environmental factors that may affect the growth of a microorganism can include the presence or absence of nutrients, pH, moisture content, oxidation-reduction potential, antimicrobial compounds, temperature, atmospheric gas composition and biological structures or barriers.

The term “biomolecule” is generally used to refer to a molecule, or a derivative thereof, that occurs in or is formed by an organism. For example, a biomolecule can include, but is not limited to, at least one of an amino acid, a nucleic acid, a polypeptide, a protein, a polynucleotide, a lipid, a phospholipid, a saccharide, a polysaccharide, and combinations thereof. Specific examples of biomolecules can include, but are not limited to, a metabolite (e.g., staphylococcal enterotoxin), an allergen (e.g., peanut allergen(s), egg allergen(s), pollens, dust mites, molds, danders, or proteins inherent therein, etc.), a hormone, a toxin (e.g.,Bacillusdiarrheal toxin, aflatoxin,Clostridium difficiletoxin etc.), RNA (e.g., mRNA, total RNA, tRNA, etc.), DNA (e.g., plasmid DNA, plant DNA, etc.), a tagged protein, an antibody, an antigen, ATP, and combinations thereof.

The terms “soluble matter” and “insoluble matter” are generally used to refer to matter that is relatively soluble or insoluble in a given medium, under certain conditions. Specifically, under a given set of conditions, “soluble matter” is matter that goes into solution and can be dissolved in the solvent (e.g., diluent) of a system. “Insoluble matter” is matter that, under a given set of conditions, does not go into solution and is not dissolved in the solvent of a system. A source can include soluble matter and insoluble matter (e.g., cell debris). Insoluble matter is sometimes referred to as particulate(s) or debris and can include portions of the source material itself (i.e., from internal portions or external portions (e.g., the outer surface) of the source) or other source residue or debris resulting from an agitation process. The analyte of interest can be present in the soluble matter or the insoluble matter.

The term “agitate” and derivatives thereof is generally used to describe the process of giving motion to a liquid composition, for example, to mix or blend the contents of such liquid composition, or to liquefy a solid source by blending with a liquid. A variety of agitation methods can be used, including, but not limited to, manual shaking, mechanical shaking (e.g., linear shaking), ultrasonic vibration, vortex stirring, manual stirring, mechanical stirring (e.g., by a mechanical propeller, a magnetic stirbar, or another agitating aid, such as ball bearings), manual beating, mechanical beating, blending, kneading, and combinations thereof.

The term “filtering” is generally used to describe the process of separating matter by size, charge and/or function. For example, filtering can include separating soluble matter and a solvent (e.g., diluent) from insoluble matter, or it can include separating soluble matter, a solvent and relatively small insoluble matter from relatively large insoluble matter. A variety of filtration methods can be used, including, but not limited to, passing the liquid composition through a filter, settling followed by aspiration or decanting, other suitable filtration methods, and combinations thereof “Settling” is used to refer to allowing the insoluble matter in the liquid composition to settle. Settling may occur by gravity or by centrifugation. The insoluble matter (or relatively large insoluble matter) can then be separated from the soluble matter (or soluble matter and relatively small insoluble matter) and solvent by aspirating the soluble matter and solvent from the insoluble matter, decanting the soluble matter and solvent, or a combination thereof.

A “filter” is generally used to describe the device used to separate the soluble matter (or soluble matter and relatively small insoluble matter) and solvent from the insoluble matter (or relatively large insoluble matter) in a liquid composition. Examples of filters can include, but are not limited to, a woven or non-woven mesh (e.g., a wire mesh, a cloth mesh, a plastic mesh, etc.), a woven or non-woven polymeric web (e.g., comprising polymeric fibers laid down in a uniform or nonuniform process, which can be calendered), a surface filter, a depth filter, a membrane (e.g., a ceramic membrane (e.g., ceramic aluminum oxide membrane filters available under the trade designation ANOPORE from Whatman Inc., Florham Park, N.J.), a polycarbonate membrane (e.g., track-etched polycarbonate membrane filters available under the trade designation NUCLEOPORE from Whatman, Inc.)), a polyester membrane (e.g., comprising track-etched polyester, etc.), a sieve, glass wool, a frit, filter paper, foam, etc., and combinations thereof.

The term “filtrate” is generally used to describe the liquid remaining after the insoluble matter (or at least the relatively large insoluble matter) has been removed from the liquid composition. Because filtering includes a broad range of methods, the term “filtrate” can also be used to refer to the supernatant that results from allowing insoluble matter (or relatively large insoluble matter) in a mixture to settle.

FIG. 1illustrates a sample preparation and collection method10according to one embodiment of the present disclosure. As shown inFIG. 1, the sample preparation and collection method10can begin with obtaining a source12. A diluent13can be combined with all or a portion of the source12and agitated to form a liquid composition14comprising the source12dissolved, dispersed, suspended and/or emulsified in the diluent13. As such, the liquid composition14is generally a mixture, and can be a solution, an emulsion, a dispersion, a suspension, or a combination thereof.

The source12, when combined with the diluent13, can include soluble matter and insoluble matter15, such that some portions of the source12can be dissolved in the diluent13, while other portions of the source12are suspended, dispersed or emulsified in the diluent13. The liquid composition14is then filtered to form a filtrate16that comprises the analyte of interest (if present). The analyte of interest can be present in the soluble matter or the insoluble matter of the liquid composition14. If the analyte of interest is present in the insoluble matter, and if a filter is employed to remove the analyte of interest from debris or unwanted material, the filter is typically adapted to allow the analyte of interest (and perhaps other similarly-sized insoluble matter) to pass through the filter as filtrate16, while restricting relatively large insoluble matter17from passing through the filter. Therefore, it should be understood that the filtrate16can also include some insoluble matter, and insoluble matter17is shown inFIG. 1as being removed from the liquid composition14for simplicity and by way of example only. A sample18comprising an analyte of interest (if present) can then be captured or collected from at least a portion of the filtrate16. Samples18from a variety of sample preparation systems can be pooled together for one or more of collection, enrichment, concentration, analysis, etc. In some embodiments, the sample18can include substantially only the analyte of interest (if present), for example, if a sample collection system used is specific to the analyte of interest. In some embodiments, the sample18will include the analyte of interest (if present) among other things, for example, if the sample collection system used is nonspecific.

Throughout the present disclosure, one or more of the liquid composition14, the filtrate16, and any samples18thereof, may be described as including the analyte of interest. However, in some embodiments, the liquid composition14may not include the analyte of interest and may lead to a negative test result when the sample is analyzed. For example, if a sample is prepared from a food source, and the sample is then is tested for a bacterium, and the food source did not include that bacterium, the liquid composition14formed from that food, and any filtrates16and samples18thereof will also not include that bacterium of interest. Thus, even if one or more of the liquid composition14, the filtrate16, and any samples18taken therefrom are described as including the analyte of interest, it should be understood that this would only be the case if the analyte of interest was present. Furthermore, the sample collection systems of the present disclosure are adapted to isolate or capture the analyte of interest from the filtrate (or liquid composition). In some embodiments, the sample collection system is specific (e.g., the sample collection system is functionalized) and will capture substantially only the analyte of interest, if it is present. In some embodiments, the sample collection system is nonspecific (e.g., the sample collection system is size-restrictive) and will capture a sample that comprises the analyte of interest, if is present, possibly among other things.

The sample preparation and collection method10illustrated inFIG. 1and described above is illustrated and described by way of example only. However, one of ordinary skill in the art should understand that the sample preparation and collection method of the present disclosure need not include every step illustrated inFIG. 1and described above. For example, in some embodiments of the present disclosure, the sample preparation and collection method does not include the filtering step, but rather a sample is collected from the liquid composition14.

The diluent13is generally a liquid and, in some embodiments, is a sterile liquid. In some embodiments, the diluent13can include a variety of additives, including, but not limited to, surfactants, or other suitable additives that aid in dispersing, dissolving, suspending or emulsifying the source for subsequent analyte testing; rheological agents; antimicrobial neutralizers (e.g., that neutralize preservatives or other antimicrobial agents); enrichment or growth medium comprising nutrients (e.g., that promote selective growth of desired microorganism(s)) and/or growth inhibitors (e.g., that inhibit the growth of undesired microorganism(s)); pH buffering agents; enzymes; indicator molecules (e.g. pH or oxidation/reduction indicators); spore germinants; an agent to neutralize sanitizers (e.g., sodium thiosulfate neutralization of chlorine); an agent intended to promote bacterial resuscitation (e.g., sodium pyruvate); or a combination thereof. In some embodiments, the diluent13includes sterile water (e.g., sterile double-distilled water (ddH2O)); one or more organic solvents to selectively dissolve, disperse, suspend, or emulsify the source; aqueous organic solvents, or a combination thereof. In some embodiments, the diluent13is a sterile buffered solution (e.g., Butterfield's Buffer, available from Edge Biological, Memphis Term.). In some embodiments, the diluent13is a selective or semi-selective nutrient formulation, such that the diluent13may be used in the selective or semi-selective growth of the desired analyte(s) (e.g., bacteria). In such embodiments, the diluent13can be incubated with the source12for a period of time (e.g., at a specific temperature) to promote such growth of the desired analyte(s).

Examples of growth medium can include, but are not limited to, Tryptic Soy Broth (TSB), Buffered Peptone Water (BPW), Universal Pre-enrichment Broth (UPB),ListeriaEnrichment Broth (LEB), Lactose Broth, Bolton broth, or other general, non-selective, or mildly selective media known to those of ordinary skill in the art. The growth medium can include nutrients that support the growth of more than one desired microorganism (i.e., analyte of interest).

In some embodiments, the source12includes the diluent13, such that the liquid composition14includes the source12and the diluent13, but the diluent13was not added separately. For example, a food source that includes a substantial amount of water or other liquid can be mixed to form the liquid composition14comprising the source12and the diluent13, without requiring the addition of a separate diluent13. In some embodiments, the source12may be substantially dissolved in the diluent13, such that the liquid composition14includes a minimal amount of insoluble matter15, making the filtering step unnecessary.

FIG. 17illustrates a sample preparation and collection system1107according to one embodiment of the present disclosure. The sample preparation and collection system1107includes a sample preparation system1100and a sample collection system1157coupled to the sample preparation system1100, such that the sample collection system1157is in fluid communication with the sample preparation system1100. The sample preparation system1100prepares a liquid composition1114(and, optionally, a filtrate1116) from a source1112, and the sample collection system1157is configured to collect a sample from the sample preparation system1100that comprises an analyte of interest, if present. The sample can be further removed (e.g., by elution) from the sample collection system1157for further processing, such as enrichment, concentration, incubation, analysis (e.g., identification or quantification of analyte(s) of interest), etc.

FIGS. 2-13illustrate various embodiments of the sample preparation system according to the present disclosure,FIGS. 18-20and23-24illustrate various embodiments of the sample collection system according to the present disclosure, andFIGS. 14-17,21-22and25illustrate various embodiments of the sample preparation and collection system according to the present disclosure (including various embodiments of the sample preparation system and the sample collection system).

FIG. 2illustrates a sample preparation system100according to one embodiment of the present disclosure. As shown inFIG. 2, the sample preparation system100includes a container102, a liner104, a lid106, a collar108, and a cover109. In some embodiments, one or more of the components of the sample preparation system100are sterile or sterilizable by sterilization and disinfection procedures such as steam, gamma radiation, ethylene oxide, hydrogen peroxide, peracetic acid, hydro-alcoholic solutions, bleach, and combinations thereof. A system having similar features to that of the sample preparation system100is described in PCT Publication No. WO 98/32539, U.S. Pat. Nos. 6,536,687 and 6,588,681, PCT Publication No. 2004/060574, PCT Publication No. 2004/060575, US Publication No. 2004/0164182, PCT Publication No. 2004/094072, PCT Publication No. WO 2007/079143, PCT Publication No. WO 2007/079188, each of which is incorporated herein in its entirety by reference.

Some embodiments of the present disclosure employ a plurality of sample preparation systems100to allow multiple sample preparation systems100be employed in parallel (or to have samples pooled) to expedite sample preparation and/or collection, and to increase productivity/output. In such embodiments, the plurality of sample preparation systems100can be at least partially integrally formed, or they can be separately formed. For example, in some embodiments, multiple liners104can be used in one relatively large container102(e.g., with multiple reservoirs for the liners104).

In some embodiments, as shown inFIG. 2, the container102is freestanding and/or self-supporting and includes a base127and a sidewall129. The term “freestanding” is generally used to refer to an object that is capable of standing on its own without collapsing or distorting, and without being held by another object. The term “self-supporting” is generally used to refer to an object that does not collapse or deform under its own weight. For example, a bag is typically not “self-supporting” in that it does not maintain its shape, but rather collapses or distorts, under its own weight. A self-supporting object is not necessarily freestanding.

The container102can be formed of a variety of materials including, but not limited to, polymeric materials, metals (e.g., aluminum, stainless steel, etc.), ceramics, glasses, and combinations thereof. Examples of polymeric materials can include, but are not limited to, polyolefins (e.g., polyethylene, polypropylene, combinations thereof, etc.), polycarbonate, acrylics, polystyrene, high density polyethylene (HDPE), polypropylene, other suitable polymeric materials capable of forming a freestanding and/or self-supporting container, or a combination thereof. The container102can be translucent (or even transparent), or opaque, and can be any suitable size, depending on the type, amount and size of source to be analyzed. For example, in some embodiments, the container102can have a capacity of 50 mL, 100 mL, 250 mL, or larger.

In some embodiments, as shown inFIG. 2, the sample preparation system100includes a liner104, which is shaped and dimensioned to be received within the container102. The liner104can be disposable (e.g., made for one-time use), to allow the container102to be reused without substantial risk of contamination and without extensive cleaning required between uses. As described in greater detail below and illustrated inFIG. 9, in some embodiments, the sample preparation system includes a liner without a container. When the liner is used without a container, it is not functioning as a “liner,” per se, and can be referred to generally as a receptacle or container.

As shown inFIG. 2, the container102defines a first reservoir120, and the liner104defines a second reservoir122. The liner104is shaped and dimensioned to be received within the first reservoir120of the container102. In some embodiments, a source112and a diluent113can be added to the first reservoir120. In some embodiments, as shown inFIG. 2, the liner104is employed, and the source112and diluent113are positioned within the second reservoir122, and the liner104is positioned within the first reservoir120. Whether added to the first reservoir120or the second reservoir122, the source112and the diluent113can be combined (and agitated) to form a liquid composition114. In some embodiments, the liner104is freestanding, and the liner104or the container102can serve as a freestanding receptacle that can contain the liquid composition114.

The source112can be added to the container102or the liner104first, followed by addition of the diluent113, the diluent113can be added first, followed by the source112, or the source112and the diluent113can be added simultaneously. Alternatively, the source112and diluent113can be combined prior to being added to the sample preparation system100.

In some embodiments in which the diluent113is added to the container102or the liner104first, a pre-measured amount of the diluent113(e.g., a sterile liquid diluent) can be sealed in the container102or the liner104with a removably coupled cover (e.g., a one-time use removable barrier film that is coupled to the container102or the liner104by one or more of an adhesive, heat sealing, ultrasonic welding, or any of the other coupling means described below), so that the cover can be removed just prior to adding the source112. Alternatively, in some embodiments, a pre-measured amount of a dry powdered media (e.g., nutrient media for analyte(s) of interest and/or growth inhibitors for analyte(s) not of interest) can be sealed in the container102or the liner104with a removably coupled cover, or the desired media can be coated or adsorbed onto an inner surface of the container102or the liner104. In such embodiments, the cover can be removed and a solvent (e.g., ddH2O) can be added to form the diluent113, either prior to or at the same time as the source112is added. Alternatively, if the source112includes enough of a liquid capable of dissolving the media, the source112can be added to the dry powdered media to form the liquid composition114that comprises the source112and a diluent113(e.g., the media dissolved in a solvent provided by the source112).

In some embodiments, the container102and/or the liner104(if the liner104is employed) can be compartmentalized to include more than one first reservoir120and/or more than one second reservoir122, respectively. Multiple reservoirs120/122can be used, for example, for multi-stage enrichment, for parallel or simultaneous enrichment of different microorganisms, or a combination thereof. By way of example, the liner104can include two second reservoirs122(referred to in this example as reservoir A and B for simplicity). A first enrichment media can be positioned in reservoir A for primary enrichment of a microorganism, and a second enrichment media can be positioned in reservoir B for secondary enrichment of the same microorganism. Reservoirs A and B can be positioned, for example, such that both are accessible for positioning of the media but that the source112can be added to one without being added to the other. After the liquid composition114has been formed and primary enrichment has occurred in reservoir A, the liquid composition114, or a portion thereof, can be moved to reservoir B for secondary enrichment. The liquid composition114can be moved to reservoir B in a variety of ways, including agitation of the sample preparation system100, breaking of a frangible barrier between the two reservoirs A and B, etc.

In some embodiments, one container102can be employed with a plurality of liners104, such that one container102can include one or more first reservoirs120, and/or one or more liners104(each including one or more second reservoirs122) can be positioned in the container102. Other configurations are possible, and one of ordinary skill in the art will recognize the different permutations possible for achieving multiple compartments. No matter what the configuration, the multiple reservoirs or compartments can be positioned side-by-side, vertically, concentrically, or a combination thereof.

The liner104can be formed of a variety of materials, including a variety of polymeric materials, including, but not limited to, a polyolefin, including, but not limited to polypropylene (e.g., low density polyethylene (LDPE)), polyethylene, and poly(methylpentene), polyamide (e.g., NYLON®), or a combination thereof. In some embodiments, the liner104is formed from a molding process, such as a thermoforming process. The liner104can be translucent (or even transparent), or opaque.

In some embodiments, as illustrated inFIG. 2, the liner104is freestanding and/or self-supporting, either of which can allow the source112and diluent113to be loaded into the liner104prior to positioning the liner104within the container102, without the liner104collapsing or distorting. In addition, a freestanding and/or self-supporting liner104can aid in weighing, source112and/or diluent113addition, transporting, handling, and/or sample removal.

In some embodiments, the liner104is self-supporting and/or freestanding while also being deformable. The term “deformable” is used to refer to a structure that can be altered from its original shape or state by pressure (e.g., positive or negative) or stress. In embodiments employing a deformable liner104, pressure can be applied to the liner104to reduce its size from its original (i.e., unstressed) dimensions. Such pressure can be used to promote removal of the liquid composition114(or a filtrate thereof) from the liner104. In such embodiments, the liner104can serve as a deformable self-supporting receptacle that can contain the liquid composition114. In some embodiments, the deformable self-supporting receptacle is also freestanding.

In some embodiments, as shown inFIG. 2, the container102includes an aperture124formed in its base127, through which a user can access the liner104to apply pressure to the liner104to cause it to deform. Such pressure can be applied directly by hand, or by an additional device, and could be a manual or automated process. The aperture124can be shaped and dimensioned according to the desired application of use. In some embodiments, base127of the container102is nothing more than the bottom of the sidewall129, or a slight inward projection of the sidewall129, such that the liner104is easily accessible at the bottom of the container102. Said another way, in some embodiments, the aperture124of the container102defines a majority of the bottom of the container102(e.g., a majority of the cross-sectional area of the container102), and the base127is only a small portion of the container102surrounding the aperture124. In embodiments that do not employ the liner104, the container102need not include the aperture124.

In some embodiments, the liner104includes a relatively rigid base126and a relatively thin and deformable sidewall128, such that when pressure is applied to the base126in a direction parallel to the longitudinal axis of the liner104(e.g., via the aperture124in the container102), the liner104deforms in the longitudinal direction (e.g., by virtue of the sidewall128collapsing rather than the base126). Alternatively, or in addition, the base126can be thicker than the sidewall128. By way of example only, in some embodiments, the thickness of the sidewall128is at least 50 μm, in some embodiments, at least 100 μm, in some embodiments, at least 150 μm, and in some embodiments, at least 200 μm. In some embodiments, the thickness of the base126is at least 225 μm, in some embodiments, 275 μm, in some embodiments, at least 300 μm, and in some embodiments, at least 350 μm.

The liner104can further include one or more of baffles, pleats, corrugations, seams, joints, gussets, weakened portions (e.g., annular weakened portions), or a combination thereof, which may be incorporated to assist in controlling the deformability of the liner104, and/or can further reduce the internal volume of liner104. In some embodiments, as described in greater detail below and illustrated inFIG. 9, the liner104includes an accordion-type configuration. In some embodiments, liner104does not include any grooves on its internal surface, particularly, at the internal junction between the base126and the sidewall128.

In some embodiments, the liner104is deliberately deformed to impart a disruption to the surface geometry of the liner104. Such a disrupted surface geometry can assist in the breakup of the source112during agitation. For example, in some embodiments, an obstruction (e.g., a relatively rigid material) can be positioned between the sidewall128of the liner104and the container102to create a different surface geometry in the sidewall128of the liner104.

As shown inFIG. 2, the container102can include indicia130to indicate the level (i.e., volume) of contents within the container102. The indicia130can be used to achieve a desired weight ratio of the liquid composition114, for example, where the weight ratio of the source112to the diluent113ranges from 1:100 to 1:1. One example of suitable indicia is described in U.S. Pat. No. 6,588,681. Alternatively, or in addition, the liner104can include indicia. To enable the use of the indicia130on the container102and/or the liner104, the container102and/or the liner104can be translucent, or even transparent to afford seeing the liquid composition114through the sidewall129of the container102and/or the sidewall128of the liner104. The sidewalls128and129may also bear other types of markings, such as trademarks, brand names, and the like. The indicia130can also be provided on a film that is dimensioned to be received within the container102or the liner104and which can be formed of a material that includes sufficient internal stresses to cause the film to press outwardly (i.e., radially) against an inner surface of the container102or the liner104.

In the embodiment illustrated inFIG. 2, the lid106is removably coupled to the liner104, and the collar108is employed to further secure the lid106to the container102. For example, inFIG. 2, the container102includes threads131at the upper end of the outer surface of the sidewall129, which are shaped and dimensioned for the collar108(having internal threads133capable of engaging with the threads131on the container102) to be screwed onto the upper end of the container102. As an alternative to using the collar108for securing the lid106to the container102, other coupling means can be employed including clamping and/or any of the other coupling means described below. In some embodiments, the liner104is not employed, and the lid106can be coupled directly to the container102. In such embodiments, the collar108need not be employed. Thus, the lid106can form a seal (e.g., a hermetic seal) with either the container102or the liner104. In some embodiments, the lid106and the container102(or the lid106and the liner104) are integrally formed or permanently coupled together.

A variety of coupling means can be employed either between the lid106and the liner104, the lid106and the container102, and/or the collar108and the container102to allow the respective components to be removably coupled to one another, including, but not limited to, gravity (e.g., one component can be set atop another component, or a mating portion thereof), screw threads, press-fit engagement (also sometimes referred to as “friction-fit engagement” or “interference-fit engagement”), snap-fit engagement, magnets, adhesives, heat sealing, other suitable removable coupling means, and combinations thereof. In some embodiments, the sample preparation system100need not be reopened after the source112and the diluent113are added, such that the container102, the liner104, the lid106and the collar108need not be removably coupled to one another, but rather can be permanently or semi-permanently coupled to one another. Such permanent or semi-permanent coupling means can include, but are not limited to, adhesives, stitches, staples, screws, nails, rivets, brads, crimps, welding (e.g., sonic (e.g., ultrasonic) welding), any thermal bonding technique (e.g., heat and/or pressure applied to one or both of the components to be coupled), snap-fit engagement, press-fit engagement, heat sealing, other suitable permanent or semi-permanent coupling means, and combinations thereof. One of ordinary skill in the art will recognize that some of the permanent or semi-permanent coupling means can also be adapted to be removable, and vice versa, and are categorized in this way by way of example only.

As shown inFIGS. 2 and 3, the lid106further includes a port132, which can be coupled to a filter134, a cylindrical portion136that is dimensioned to be received within the liner104, and a generally conical (e.g., frusto-conical) portion138that extends from the cylindrical portion136to the port132. At the junction between the cylindrical portion136and the conical portion138, the lid106further includes a lip140that extends radially outwardly from the cylindrical portion136and the conical portion138.

In some embodiments, the filter134is coupled directly to the lid106. In some embodiments, as shown inFIGS. 2-3, the filter134can be supported by a frame135and coupled to the lid106via the frame135. The frame135can form a portion of the filter134, the frame135can be a part of the lid106, or the frame135can be a separate element that is coupled to both the filter134and the lid106. The frame135can be formed of a variety of materials, including, but not limited to, a variety of polymers, metals, ceramics, glasses, and combinations thereof. In the embodiment illustrated inFIGS. 2-3, the filter134is formed of a metal mesh, and the frame135is formed of a polymer that is bonded to the metal filter134. The frame135is coupled to the lid106, as described in greater detail below.

The filter134and the frame135of the embodiment illustrated inFIGS. 2 and 3are shaped and dimensioned so as to extend below the bottom end of the lid106, such that when the sample preparation system100is assembled, the filter134and the frame135extend into the second reservoir122of the liner104(or the first reservoir120of the container102). However, the filter134and frame135can take on a variety of shapes and sizes. In some embodiments, for example, the frame135can include a rigid upper portion (e.g., that is coupled to the lid106) and a rigid lower portion, and the filter134can be coupled therebetween, and the filter134can be collapsible. Such an embodiment is described in greater detail below and illustrated inFIG. 9.

The cylindrical portion136of the lid106includes a plurality of circumferential outwardly-projecting protrusions142to allow the cylindrical portion136to be snap-fit or press-fit to the inner surface of the liner104. In some embodiments, the inner surface of the liner104can include inwardly-projecting protrusions that are used either in lieu of the outwardly-projecting protrusions142, or in addition to the outwardly-projecting protrusions142(e.g., to form a mating relationship therewith).

The liner104can include a lip144that projects radially outwardly from the sidewall128of the liner104, and which can form an abutting relationship with an upper surface146of the container102and the lip140of the lid106, such that when the sample preparation system100is assembled, the lip144of the liner104is positioned between the lip140of the lid106and the upper surface146of the container102, and a seal (e.g., a hermetic seal) is formed. As shown inFIG. 2, the collar108includes an inwardly-projecting lip156, such that when the collar108is coupled to the container102, the lip156of the collar108presses the lip140of the lid106into contact with the lip144of the liner104, which is pressed into contact with the upper surface146of the container102(e.g., to form a higher integrity seal). The above-described means for assembling the sample preparation system100and for forming a seal between the components of the sample preparation system100are described and illustrated by way of example only. One of ordinary skill in the art will understand, however, that a variety of other mechanisms could be employed to assemble the components of the sample preparation system100and to form a seal (e.g., a liquid-tight seal, a hermetic seal, or a combination thereof), such that the sample preparation system100is inhibited from leaking under normal operating conditions.

While the lid106of the embodiment illustrated inFIGS. 2 and 3is illustrated as having a generally conical or frusto-conical shape. It should be understood that the lid106could have a variety of other shapes, including, but not limited to, a cylindrical shape, a tubular shape having a rectangular or square cross-sectional area, or other shapes suitable to being coupled to the other components of the sample preparation system100. Similarly, the container102, the liner104, and the collar108could have a variety of other shapes than the substantially cylindrical shapes illustrated inFIG. 2. In addition, the lid106can be dimensioned to accommodate the other components of the sample preparation system100.

The lid106can be formed of a variety of materials, including the materials listed above with respect to the container102. The lid106can be translucent (or even transparent), or opaque, depending on the application of use.

The collar108can be formed of a variety of materials, including, but not limited to a variety of polymeric materials, metal materials, and combinations thereof. For example, the collar108can be formed of a molded plastic component, or a machined metal (such as aluminum) component. In some embodiments, the collar108is formed of a molded plastic component comprising glass fiber reinforced polypropylene.

As shown inFIG. 2, the port132of the lid106is generally cylindrical and tubular in shape, such that the port132defines a portion152of the inner surface153of the lid106and an opening154in the lid106. The lid106is hollow and is in fluid communication with the second reservoir122when the sample preparation system100is assembled. The port132does not need to be cylindrical and can instead take on any shaped necessary for a given application. In the embodiment illustrated inFIGS. 2 and 3, the filter134is coupled to the port132(i.e., via the frame135) such that the filter134is in fluid communication with the lid opening154, as well as the second reservoir122.

In the embodiment shown inFIG. 2, the cover109is shaped and dimensioned to receive at least a portion of the port132. As a result, the cover109can be coupled to the port132of the lid106to close the opening154in the lid106and to seal (e.g., hermetically seal) the sample preparation system100from the environment. The cover109can be coupled to the lid106using any of the above-described coupling means. The cover109can be integrally formed with the lid106(e.g., a flip-top snap-on cover, as described in greater detail below and illustrated inFIG. 13), or the cover109can be separate from the lid106(e.g., a screw-on cover, as described in greater detail below and illustrated inFIGS. 9-12). The cover109can be formed of a variety of materials, including the materials listed above with respect to the container102or the collar108.

In some embodiments, the lid106includes a frangible or penetrable barrier or a removable film separating at least a portion of the interior of the lid106from the environment, such that the barrier can be punctured or pierced or the film removed to access the interior of the lid106. In such embodiments, the cover109need not be employed.

As shown inFIG. 3, the inner surface153of the lid106can include a variety of inner circumferential edges to which other components (e.g., additional or alternative filters, the concept of which is illustrated inFIGS. 5-6and described below) can be coupled. The inner circumferential edges can have any orientation desired, depending on what other components are desired to be coupled to the edges. In some embodiments, the inner circumferential edges are oriented substantially orthogonally to the central longitudinal axis of the lid106, such that the edges are substantially horizontal inFIG. 3.

In addition, the lid106can include a variety of inwardly-extending members to which other components (e.g., filters) can be coupled. For example, as shown inFIG. 3, the filter134is supported by the frame135, and the lid106includes inwardly-extending members155to which the frame135can be coupled via a variety of coupling means, including, but not limited to, any of the coupling means described above. The inwardly-extending members155can be integrally formed with the lid106.

The filter134can be of any geometrical shape to sufficiently filter the liquid composition114. In some embodiments, the filter134is deformable and/or collapsible (i.e., such that the filter134folds under its own weight). In some embodiments, the filter134is rigid and retains its shape (i.e., does not fold under its own weight). The size and number of filters134used in a sample preparation system100, and porosity thereof, may vary, depending on the desired analyte(s) and the insoluble matter in the source112.

By way of example only, in some embodiments, the liquid composition114comprises food, the desired analyte is bacteria, and the insoluble matter is food particles or debris. In such embodiments, for example, the filter134can be selected to retain and/or separate the food particles, while allowing the bacteria of interest (if present) to pass through the filter134for subsequent analysis. By way of further example, in some embodiments, the liquid composition114comprises a lysed bacterial cell culture, the desired analyte is one or more of DNA, RNA, a protein, or a metabolite, and the insoluble matter is cellular debris. In such embodiments, for example, the filter134can be selected or treated (e.g., derivatized with biomolecule-binding agents, such as antibodies) to retain and/or separate the cellular debris, while allowing the desired DNA, RNA, protein, and/or metabolite to pass through the filter134for subsequent analysis. Alternatively, for example, the filter134can be selected or treated to retain the desired DNA, RNA, protein and/or metabolite, while allowing the cellular debris to pass through the filter134.

The filter134can have a variety of pore sizes sufficient for retaining particles from the liquid composition114, while allowing the desired analyte(s) (if present) in the liquid composition114to pass through the filter134for extraction and/or sampling. Alternatively, the filter134can be sized, charged and/or functionalized to retain the desired analyte(s), while allowing undesired material to pass through the filter134. In such embodiments, the sample can include at least a portion of the filter134, which can be further processed (e.g., enriched, concentrated, analyzed, etc.).

In some embodiments, the filter134has an average pore or mesh size of at least 2 μm, in some embodiments, at least 5 μm, in some embodiments, at least 40 μm, in some embodiments, at least 80 μm, and in some embodiments, at least 120 μm. In some embodiments, the filter134has an average pore or mesh size of at most 2000 μm, in some embodiments, at most 1000 μm, in some embodiments, at most 500 μm, in some embodiments, at most 200 μm, in some embodiments, at most 50 μm, in some embodiments, at most 10 μm and in some embodiments, at most 1 μm (e.g., if it is desired to restrict bacteria from passing through the filter134).

In the embodiment illustrated inFIGS. 2 and 3, the filter134is located in the lid106, generally in line with the central longitudinal axis of the lid106. However, in some embodiments, the filter134is positioned in an “off-axis” position of the lid106. For example, an aperture158is shown in dashed lines inFIG. 2to represent a possible “off-axis” position for the filter134in the lid106. An alternative or an additional port can be positioned at the location of the aperture158and coupled thereto. The filter134can be permanently or removably coupled at one or both locations.

In some embodiments, particularly embodiments that do not employ the liner104, the filter134can alternatively, or additionally, access the interior of the sample preparation system100(i.e., the first reservoir120of the container102) via an aperture160in the sidewall129of the container102or the aperture124in the base127of the container102(or an aperture formed in a different location of the base127of the container102). In such embodiments, the filter134can be permanently or removably coupled to the sidewall129or the base127of the container102. An alternative or additional port can be positioned at the location of the apertures160and124and coupled thereto. In some embodiments, the sample preparation system100can include more than one port, such as the port132in the lid106, an additional port at the location of the aperture158in the lid106, an additional port at the location of the aperture160in sidewall129of the container102, and/or an additional port at the location of the aperture124in the base127of the container102. The cover109or a similar closure device can be used to seal any of the ports at any location on the sample preparation system100.

Because of the different locations possible for the filter134, the filter134can be shaped and dimensioned to accommodate its position in the sample preparation system100and the particular application of use. In any of the possible locations for the filter134, the filter134can be positioned wholly above or wholly below the level165of the liquid composition114, or the filter134can be positioned partially above and partially below the level165of the liquid composition114, depending on the type of filtering desired, and how the filter134is intended to filter the liquid composition114. For example, in the embodiment illustrated inFIG. 2, the filter134is coupled to the port132and, depending on how high the level165of the liquid composition114is, would typically extend from the port132into the interior of the sample preparation system100, such that the filter134is positioned partially above and partially below the level165of the liquid composition114.

The filter134is in fluid communication with the interior of the liner104and the liquid composition114and acts to filter the liquid composition114to form a filtrate116. The filtrate116is disposed within the volume of the filter134and can be extracted and/or sampled from the adjacent port132. In embodiments employing filters134at multiple locations, the filtrate116can be sampled from any of the ports or apertures described above.

The filter134can be formed from a variety of materials, including, but not limited to one or more of nylon, fluorinated polymers (e.g., polytetrafluoroethylene (PTFE)), cellulosics (e.g., modified celluloses such as cellulose esters (e.g., cellulose acetate) and nitrocelluloses), fiberglass, papers, and combinations thereof. In some embodiments, the filter134can be formed of a woven web, a nonwoven web, a molded structure, a foam, fabric, a fibrous web, and combinations thereof. The surface area of the filter134can be increased by pleating the filter134, or by other similar techniques. The thickness of the filter134can be controlled by calendering or felting processes.

In some embodiments (no matter which location the filter134is in), the filter134can be used as a retainer or holder of the source112. An example of this concept is illustrated inFIG. 4and described below.

As mentioned above, the liner104can be disposable. In addition, in some embodiments, one or more of the lid106, the cover109and the filter134can also be disposable. For example, in some embodiments, the lid106can be coupled to the liner104, and the cover109and the filter134can be coupled to the lid106. The liner104, the lid106, the filter134and the cover109can form a disposable portion of the sample preparation system100that can be used without contaminating the container102or the collar108. The disposable portion can be removed from the container102and disposed. The container102and collar108can then be reused with a new liner104, lid106, filter134and cover109.

FIG. 4illustrates a sample preparation system200according to another embodiment of the present disclosure, wherein like numerals represent like elements. The sample preparation system200shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 2-3. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 2-3are provided with the same reference numerals in the200series. Reference is made to the description above accompanyingFIGS. 2-3for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 4.

The sample preparation system200includes a container202and a lid206. The sample preparation system200does not include a liner, and the lid206is coupled directly to the container202. The sample preparation system200further includes a filter234which is fluidly coupled to an aperture260formed in a sidewall229of the container202. Unlike the filter134of the sample preparation system100, the filter234functions as a retainer or holder for the source212.

The filter234can be permanently coupled to the container202and the source212can be added to the filter234, or the filter234can be removably coupled to the container202, and the source212can be added to the filter234prior to or after the filter234is coupled to the container202. In some embodiments, the filter234can be free-floating within the first reservoir220of the container202, such that the filter234contains the source212and the diluent213is able to flow in and out of the interior of the filter234to mix with the source212.

The source212is positioned within the filter234, and the filter234is positioned at least partially below the level of the diluent213in the container202and is in fluid communication with the interior of the container202, such that the source212can be combined with the diluent213to form a liquid composition214within the filter234. The liquid composition214positioned within the filter234includes the analyte(s) of interest (if present) in the diluent213, as well as any other soluble or insoluble matter from the source212. During agitation, the source212and the diluent213can be mixed to allow the source212to be dissolved, dispersed, suspended and/or emulsified in the diluent213. The pore size of the filter234will be adapted such that the diluent213and any analyte(s) of interest (if present) in the diluent213are free to flow in and out of the filter234, such that the resulting filtrate216is positioned outside of the filter234and within the reservoir220of the container202, and includes the diluent213and any present analyte(s) of interest.

The filtrate216can be sampled from any of a variety of ports or apertures, including the port232in the lid206, the aperture258in the lid206, an additional aperture in the sidewall229of the container202, and/or an aperture224in the base227of the container202. In addition, instead of being coupled to the sample preparation system200via the aperture260, the filter234can instead be coupled to the sample preparation system200via any of a variety of ports or apertures, including the port232in the lid206, the aperture258in the lid206, and/or an aperture224in the base227of the container202. In some embodiments, as shown inFIG. 4, one or more of the ports can include an additional filter234′ that functions in the same way as the filter134of the sample preparation system100. In such embodiments, the filtrate216can be further filtered by the filter234′, and the resulting filtrate216′ is disposed within the filter234′ and can be extracted and/or sampled from the adjacent port (i.e., port232inFIG. 4).

The sample preparation system200can further include a liner, in which case the diluent213and resulting filtrate216can be positioned within the liner, provided that sufficient sealing is provided between the liner and the container202at the location of the aperture260.

FIGS. 5-6illustrate a sample preparation system300according to another embodiment of the present disclosure, wherein like numerals represent like elements. The sample preparation system300shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 2-3. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 2-3are provided with the same reference numerals in the300series. Reference is made to the description above accompanyingFIGS. 2-3for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIGS. 5-6.

FIGS. 5-6show only the lid306of the sample preparation system300. The other components of the sample preparation system300can be assumed to include any of the other respective components of the sample preparation systems described above and illustrated inFIGS. 2-4, and thus for simplicity, are not shown inFIGS. 5-6.

The lid306is substantially similar to the lid106described above and illustrated inFIGS. 2-3, except that the lid306includes a filter334that is substantially planar and coupled to the inner surface353of the lid306. The inner surface353of the lid306includes an upper inner circumferential edge370and a lower inner circumferential edge368. As shown inFIG. 5, the upper inner circumferential edge370includes a downwardly facing surface that extends from an outer circumference371to an inner circumference373. Similarly, the lower inner circumferential edge368includes a downwardly facing surface that extends from an outer circumference376to an inner circumference378. The outer periphery of the filter334is coupled to the upper inner circumferential edge370of the inner surface353. In addition, the filter334is in contact with retaining walls372. The retaining walls372extend downwardly from the inner surface353of the lid106to retain the outer periphery of the filter334.

The filter334can be coupled to the lid306using the same coupling means described above with respect to the lid106. The filter334can be permanently or removably coupled to the lid306. The degree of coupling between the filter334and the lid306may vary depending on a number of factors including, but not limited to, the filter334material, the lid306material, the size and texture of the coupled surface area, and the type of coupling means used. For example, if the filter334includes frayed edges, a wider and/or knurled coupling surface area may be used (e.g., the upper inner circumferential edge370can be knurled). Such a wider and/or knurled ultrasonic weld may capture frayed edges of the filter334. To minimize the amount of fraying, the filter334can be cut using a laser, which can fuse the edges of the filter334. Because the resulting laser-cut filter334would include a minimum amount of fraying, if any, a narrower coupling area can be used. In some embodiments, the coupling area extends completely around the outer periphery of the filter334. In some embodiments, the coupling area can have an average width (i.e., a dimension within the same plane and substantially perpendicular to the outer periphery of the filter334) of up to 5.0 mm, and in some embodiments, ranging from 1.0 mm to 3.0 mm. Alternatively, the filter334can be integrally formed with the lid306, for example, by a molding process.

The filter334can be formed of the same material as the lid306or a different material. The filter334may be flexible, or semi-rigid. In some embodiments, the filter334is formed from a nylon nonwoven or woven fabric, while the lid306is an injection molded part formed of a polymer, such as polypropylene. In such embodiments, the nylon filter334can be coupled to the lid306via an ultrasonic welding technique. During ultrasonic welding, at least a portion of the upper inner circumferential edge370can melt to mechanically bond the filter334. Since nylon has a higher melting temperature than polypropylene, the nylon filter334can maintain its structural integrity during the ultrasonic welding process. In such embodiments, at least a portion of the upper inner circumferential edge370can enter into a portion of filter334, thereby encapsulating a portion of the filter334.

The filter334can have dimensions and shapes that vary for a given application. The filter334can have any desired shape including, but not limited to, a circular shape, a square shape, a rectangular shape, a triangular shape, a polygonal shape, a star shape, other suitable shapes, and combinations thereof. In the embodiment illustrated inFIGS. 5 and 6, the filter334has a substantially circular shape.

The dimensions of the filter334may vary depending on the size of the lid306. In some embodiments, the filter334has a largest dimension (i.e., length, width, or diameter) ranging from 15 mm to 100 mm, although the filter334may have smaller or larger dimensions. For example, in some embodiments, the filter334can have a circular shape and a diameter of 56 mm.

With continued reference toFIGS. 5 and 6, the retaining walls372can be integrally formed with the lid306. In some embodiments, as shown inFIG. 5, the lid306comprises two or more retaining walls372, wherein (i) each retaining wall372has a circumferential length greater than its thickness, (ii) each retaining wall372is positioned along an outer periphery of the filter334, and (iii) the total circumferential length of the two or more retaining walls372is less than the total circumferential length of the outer periphery of the filter334.

As shown inFIG. 5, the lid306includes four retaining walls372equally spaced from one another along outer circumference371of the upper inner circumferential edge370. In some embodiments, each retaining wall372has a thickness ranging from 800 μm to 1200 μm, a length (i.e., in this exemplary embodiment, an arc length) extending a distance ranging from 1.0 mm to 22.0 mm along outer circumference371, and a height ranging from 1.0 mm to 5.0 mm. In some embodiments, each retaining wall372has a segmented configuration so as to not inhibit (or to minimize the effect on) fluid flow around the retaining wall372.

The lid306includes an opening354and inwardly-extending members355. The inwardly-extending members355can be used to couple an additional filter (not shown) to the lid306in the same way that the filter134is coupled to the lid106inFIGS. 2 and 3. In such embodiments, the filter334is located below the additional filter, and the additional filter can have a length dimension less than the distance from the top the lid306to the filter334.

In some embodiments, as shown inFIGS. 5 and 6, the filter334has a total surface area that is greater than a smallest cross-sectional area of the lid306. In the lid306, the smallest cross-sectional area is the cross-sectional area of lid opening354. In some embodiments, more than one filter is coupled to the lid306in a similar manner as the filter334. For example, in some embodiments, the filter334or an additional filter (not shown) can be coupled to the lower inner circumferential edge368. That is, one or more filters334can be coupled to the lid306and positioned anywhere along the inner surface353of the lid306. In embodiments employing more than one filter334, the filters334can be similar to one another or different from one another. That is, the filters334can be formed of the same or different materials, and the filters334can have the same or sequentially smaller pore sizes.

As an example, a first filter334can be coupled to the upper inner circumferential edge370and can have a diameter of 56 mm, an element pore size of 80 μm, and can be at least partially surrounded by one or more retaining walls372, while a second filter334can be coupled to the lower inner circumferential edge368and can have a diameter of 96 mm, an element pore size of 200 μm, and can be at least partially surrounded by the inner surface353of the lid306.

Any of the above-described filters134,234and334can be used in combination with one another in one sample preparation system. For example, as described above, the filter134can be used in combination with the filter234and/or the filter334, to provide a series of filters for different applications, and/or for the removal of successively smaller particulates from the liquid composition.

Alternatively, or in addition, more than one of each type of filter134,234or334can be employed (and in some embodiments, can be nested) for the removal of successively smaller particulates from the liquid composition. For example, the filters may be arranged where a coarse filter acts as a pre-filter with a larger pore size relative to subsequent filters, which have successively smaller pore sizes for the collection of a filtrate. The filters may be arranged for use of the sample preparation system in an upright position, and/or the filters may be arranged for use of the sample preparation system when it is tipped or inverted.

FIG. 7illustrates a sample preparation system400according to another embodiment of the present disclosure, wherein like numerals represent like elements. The sample preparation system400shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and5-6. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 2-3and5-6are provided with the same reference numerals in the400series. Reference is made to the description above accompanyingFIGS. 2-3and5-6for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 7.

The sample preparation system400includes a container402having a first reservoir420, a liner404having a second reservoir422and dimensioned to be received in the first reservoir420of the container402, a lid406, a collar408, and a plunger437. The lid406is similar to that of lids106,206and306described above and illustrated inFIGS. 2-6, but further includes two upwardly-extending projections439, which allow the sample preparation system400to be coupled to other devices, or provide coupling means for a cover (not shown). The lid406includes a port432, which includes a plurality of ridges441that can provide alternative or additional coupling means for coupling the sample preparation system400to a cover or other devices. The lid406further includes a filter434that is substantially similar to the filter334shown inFIGS. 5-6and described above.

In some embodiments, as shown inFIG. 7, the plunger437is configured to apply positive pressure to the exterior of the liner404when the plunger437is moved in a first direction D1toward the top of the container402. As shown inFIG. 7, when the plunger437is used to apply pressure to the exterior of the liner404, the liner404is compressed, the volume in the second reservoir422is reduced, and a liquid composition414(including a source412and a diluent413) is forced through the filter434to form a filtrate416that collects inside the lid406(e.g., when the sample preparation system400is inverted as shown inFIG. 7). The filtrate416can then be moved out of the sample preparation system400via the port432.

In some embodiments, the plunger437is configured to apply negative pressure to the interior of the liner404. For example, in some embodiments, the plunger437is coupled to the liner404, such that when the plunger437is moved in a second direction D2opposite the first direction D1, toward the bottom of the container402, the liner404expands, which creates a reduced pressure in its interior (i.e., the second reservoir422), and which establishes a pressure differential between the second reservoir422and the exterior of the sample preparation system400. This pressure differential can cause fluid to move into the second reservoir422via the port432, for example. As a result of the plunger437cooperating with the exterior of the liner404to create a pressure differential, the plunger437can be used without contacting the liquid composition414and can be reused without risk of contamination.

In some embodiments, as shown inFIG. 7, the plunger437can include a handle443that is dimensioned to be received in an aperture424of the base427of the container402. In some embodiments, the handle443of the plunger437can be sized more closely to the size of the aperture424, and/or a sealing means (e.g., an o-ring) can be positioned between the handle443and the aperture424to form a seal. In the embodiment illustrated inFIG. 7, the handle443has a smaller diameter than the portion of the plunger437that contacts the liner404(e.g., a base426of the liner404). The portion of the plunger437that contacts the liner404is dimensioned to be received in the first reservoir420of the container402. However, in some embodiments, the plunger437has a uniform cross-section or a gradually decreasing cross-section (e.g., in the second direction D2), and the aperture424in the container402is sized accordingly. The plunger437shown inFIG. 7is shown by way of example only, but one of ordinary skill in the art should understand that a variety of shapes and sizes of plungers can be used without departing from the spirit and scope of the present disclosure.

The plunger437can be formed of a variety of materials, including the materials listed above with respect to the container102, and the plunger437can be solid or hollow. The plunger437can be translucent (or even transparent), or opaque, depending on the application of use.

FIG. 8illustrates a sample preparation system500according to another embodiment of the present disclosure, wherein like numerals represent like elements. The sample preparation system500shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and7. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 2-3and7are provided with the same reference numerals in the500series. Reference is made to the description above accompanyingFIGS. 2-3and7for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 8.

As shown inFIG. 8, the sample preparation system500includes a container502that includes a first reservoir520, a liner504dimensioned to be received in the first reservoir520and including a second reservoir522, and a lid506. A collar (not shown) can also be employed to further secure the components of the sample preparation system500together. The second reservoir522is adapted to contain a liquid composition514comprising a source512and a diluent513. The sample preparation system500further includes a plunger537coupled to a filter534. The filter534is adapted to filter the liquid composition514to form a filtrate516that comprises the analyte of interest (if present).

The container502includes a base527, a sidewall529, and an aperture524defined in the base527. The liner504includes a sidewall528and a base526that can be accessed, for example, via the aperture524in the base527of the container502. The lid506includes a port532that defines an opening554in the lid506and the sample preparation system500. The plunger537includes a handle543that is dimensioned to be received in the port532, such that the handle543can be accessed from outside of the sample preparation system500to force the filter534through the liquid composition514. In some embodiments, the handle543of the plunger537can be sized more closely to the size of the opening554, and/or a sealing means (e.g., an o-ring) can be positioned between the handle543and opening554to form a seal. The lid506further includes an off-axis aperture558defined in a second port of the lid506, which can serve, for example, as a degassing outlet to allow for the release of pressure from within the sample preparation system500.

In some embodiments, as shown inFIG. 8, the filter534can be dimensioned to fit within the second reservoir522of the liner504. In such embodiments, the filter534can form a seal with the sidewall528of the liner504by virtue of the deformability of the liner504and does not necessarily require additional sealing means between the outer surface of the filter534and the inner surface of the sidewall528of the liner504. The deformability of the liner504can also allow for wider tolerances, such that the filter534does not have to be sized within a narrow range to still be able to cooperate with the liner504.

Alternatively, in some embodiments, the sample preparation system500does not include a liner504, and the filter534can be configured to cooperate with the container502. For example, the filter534can be sized to fit within the first reservoir520of the container502. In some embodiments, the sample preparation system500can include sealing means (e.g., an o-ring) positioned between the filter534and the sidewall529of the container502. In some embodiments, the sidewall529of the container502is straight up and down (i.e., perpendicular to the base527) to facilitate sealing the filter534with the sidewall529. In some embodiments, the filter534includes an outer deformable (e.g., elastomeric) flange to allow the filter534to accommodate a taper in the sidewall529of the container502. Such a flange could also be incorporated into embodiments employing the filter504.

As the plunger537is pressed downwardly along a direction D1, the filter534moves downwardly through the liquid composition514, such that relatively large insoluble matter (i.e., any particulates having a size greater than the pore size of the filter534) are maintained below the filter534, and any soluble matter and relatively small insoluble matter (i.e., any particulates having a size less than the pore size of the filter534) pass through the filter, such that the filtrate516is formed above the filter534in the second reservoir522. The plunger537can be pressed in the direction D1to a set position (e.g., the liner504, the filter534and/or the plunger537can include one or more stops, the plunger537can be sized to only accommodate a certain depth in the second reservoir522, etc.), or to a position where any remaining insoluble matter in the liquid composition514is at least partially compressed by the filter534.

In some embodiments, the handle543of the plunger537can be hollow and in fluid communication with the second reservoir522. In such embodiments, at least a portion of the filtrate516can be received in the interior of the handle543of the plunger537and can be removed from the sample preparation system500via the handle543. In such embodiments, the plunger537can include a cover dimensioned to receive the upper end of the handle543. Alternatively, the plunger537can be hollow and not covered at its base by the filter534, such that at least a portion of the liquid composition514can be received in the interior of the handle543of the plunger537. Such embodiments can allow the liquid composition514to take up less space in the bottom of the second reservoir522and can allow the filter534to be moved further down in the second reservoir522along the direction D1.

FIGS. 9-12illustrate a sample preparation system600according to another embodiment of the present disclosure, wherein like numerals represent like elements. The sample preparation system600shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 2-3. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 2-3are provided with the same reference numerals in the600series. Reference is made to the description above accompanyingFIGS. 2-3for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIGS. 9-12.

As shown inFIG. 9, the sample preparation system600includes a receptacle604, a lid606, a cover609, and a filter assembly633. The receptacle604is deformable, self-supporting and freestanding. The receptacle604includes a base626and a sidewall628. The sidewall628includes an accordion-type configuration and includes a plurality of pleats or folds645(e.g., a plurality of annular pleats or folds645) to allow the sidewall628to be folded at each pleat645and to facilitate the collapse of the receptacle604substantially along its longitudinal axis, and particularly, to facilitate the collapse of the receptacle604substantially uniformly substantially along its longitudinal axis. In the embodiment illustrated inFIG. 9, the sidewall628includes a plurality of pleats or folds645by way of example only. However, it should be understood that the sidewall628can include other structures that would allow the sidewall628to collapse substantially uniformly substantially along its longitudinal axis, such as annular weakened portions in the sidewall628that are less rigid and/or less thick than the remainder of the sidewall628to allow the sidewall628to buckle at the locations of the annular weakened portions. Other suitable structures are also possible and within the spirit and scope of the present disclosure.

The base626of the receptacle604can be reinforced, made of a more rigid material, and/or made to be thicker relative to the sidewall628to encourage the receptacle604to collapse along its longitudinal axis. The receptacle604includes a reservoir622that is adapted to contain a liquid composition that comprises a source and a diluent.

The receptacle604can be formed of a variety of materials, including the materials listed above with respect to the liner104. The receptacle604can be translucent (or even transparent), or opaque, depending on the application of use. Any or all of the components of the sample preparation system600can be disposable (e.g., made for one-time use).

The lid606includes a port632, which can be coupled to the filter assembly633, a cylindrical portion636that is dimensioned to be received within the receptacle604, and a generally conical (e.g., frusto-conical) portion638that extends from the cylindrical portion636to the port632. At the junction between the cylindrical portion636and the conical portion638, the lid106further includes a lip640that extends radially outwardly from the cylindrical portion636and the conical portion638. The port632of the lid606is generally cylindrical and tubular in shape, such that the port632includes an inner surface652and defines an opening654in the lid606, and in the sample preparation system600, when assembled.

The cylindrical portion636of the lid606includes a plurality of circumferential outwardly-projecting protrusions642to allow the cylindrical portion636to be snap-fit or press-fit to the inner surface of the receptacle604. The receptacle604can include an upper surface644that can form an abutting relationship with the lip640of the lid606. The lid606and the receptacle604can be coupled together using any of the above removable or permanent coupling means in order to form a seal (e.g., a liquid-tight seal, a hermetic seal, or a combination thereof), such that the sample preparation system600is inhibited from leaking during normal operation. For example, the plurality of circumferential outwardly-projecting protrusions642can be ultrasonically-welded to the inner surface of the receptacle604.

The filter assembly633includes a frame635and a filter634. The frame635includes an upper portion635aand a lower portion635b, and the filter634is coupled therebetween. The upper portion635aof the frame635is shaped and dimensioned to be coupled to the port632of the lid606and received within the port632of the lid606and the reservoir622of the receptacle604. The frame635need not include the lower portion635b, but the lower portion635bgives the filter634additional weight and aids in exposing the filter634to the liquid composition in the reservoir622of the receptacle604.

The upper portion635aincludes a tubular body647dimensioned to be received in the port632of the lid606, a lip649coupled to the upper end of the tubular body647dimensioned to sit atop the port632of the lid606, and a plurality of ribs651. The ribs651are circumferentially-spaced about the tubular body647. The embodiment illustrated inFIG. 9includes two ribs651, but as few or as many as necessary can be used. The ribs651are shaped to be coupled to the lid606in a snap-fit engagement. Particularly, the ribs651each include a cam surface675adapted to slide along the inner surface652of the port632as the upper portion635aof the frame is moved into the port632. In addition, the cam surface675of each rib651causes the respective rib651to be forced radially inwardly as the tubular body647is moved into the port632, and further allows the respective rib651to snap (e.g., radially outwardly) into position under the bottom of the port632(i.e., on the inside of the lid606).

The filter assembly633can then be removed from the lid606by pulling upwardly on the lip649of the frame635with sufficient force to move at least one rib651inwardly far enough to bring its cam surface675into contact with the inner surface652of the port632, and to continue sliding the cam surface675upwardly along the inner surface652until the rib651is released from contact with the inner surface652of the port632. Alternatively, the filter assembly633can be removed from the lid606by moving at least one rib651radially inwardly while applying an upward force to bring the cam surface675of the respective rib651into contact with the inner surface652of the port632, or by squeezing the ribs651toward one another (e.g., radially inwardly) and moving the upper portion635aof the frame635upwardly out of the port632.

The filter634illustrated inFIG. 9is collapsible and can be caused to hang downwardly in the reservoir622of the receptacle604at least partially by the weight of the lower portion635bof the frame635.

The cover609is shaped and dimensioned to receive at least a portion of the port632. As a result, the cover609can be coupled to the port632of the lid606to close the opening654in the lid606and to seal (e.g., hermetically seal) the sample preparation system600from ambience. The cover609can be coupled to the lid106using any of the above-described coupling means. In the embodiment illustrated inFIG. 9, the port632of the lid606includes a plurality of threads674adapted to matingly engage with threads (not shown) on the inside of the cover609, such that the cover609can be screwed onto the port632. However, any of the other coupling means described above can be employed to couple the cover609to the lid606to close the opening654in the lid606. The cover609and the lid606can together form a lid assembly677, and the lip649of the filter assembly633can be sandwiched between the cover609and the upper end of the port632of the lid606when the sample preparation system600is assembled and closed.

FIG. 10illustrates the lid assembly677and the filter assembly633with the cover609coupled to the lid606, and the filter assembly633coupled therebetween. The filter634is shown in a compressed state, such that the filter assembly633is contained in the interior of the lid606. The lower portion635bof the filter frame635is rigid relative to the collapsible filter634, which aids in collapsing the filter634along its longitudinal axis, such that the filter634can be compressed into the interior of the lid606by pressing upwardly on the lower portion635bof the frame635. A removable barrier film679can be coupled to a lower surface681of the lid606to maintain the filter634in a compressed state within the interior of the lid606. The lid assembly677can be sterilized and packaged with the filter634in its compressed state and the filter assembly633contained inside the lid606by the removable barrier film679. A user can then remove the removable barrier film679prior to use (e.g., in a sterile environment) to allow the filter634(and the lower portion635bof the frame635, if employed) to hang below the lid assembly677in an uncompressed state. The removable barrier film679can also be removed just prior to coupling the lid606to the receptacle604to allow the filter634to drop into the reservoir622of the receptacle604. The uncompressed state of the filter634following removal of the removable barrier film679is shown inFIG. 11.

The removable barrier film679can be coupled to the lid606using any of the coupling means described above, and can be formed of a variety of materials, including, but not limited to, a polyolefin, including, but not limited to polypropylene (e.g., low density polyethylene (LDPE)), polyethylene; poly(methylpentene); polyamide (e.g., NYLON®); compressed blown microfiber (cBMF); urethane; polyester; polycarbonate; and combinations thereof. In some embodiments, the removable barrier film679can include, for example, a heat sealed “strippable” film, such as a 3M™ SCOTCHPAK™ release liner (3M Company, St. Paul, Minn.). The removable barrier film679can be translucent (or even transparent), or opaque. The removable barrier film679can be formed by a variety of processes, including, but not limited to a molding process, extrusion, a blow film forming process, etc., and combinations thereof.

In some embodiments, as shown inFIG. 12, the cover609includes a frangible barrier683which can be punctured to access either the reservoir622of the receptacle604, or the volume within the filter634. The barrier683can include a membrane, a non-porous film, and combinations thereof. In addition, the frangible barrier683can be formed of a variety of materials that allow the barrier683to be frangible (e.g., punctured by a pipette tip), including, but not limited to, a polyolefin, including, but not limited to polypropylene (e.g., low density polyethylene (LDPE)), polyethylene; poly(methylpentene); polyamide (e.g., NYLON®); compressed blown microfiber (cBMF); urethane; polyester; polycarbonate; synthetic or natural elastomers; 3M™ TEGADERM™ film dressing (3M Company, St. Paul, Minn.), and combinations thereof. In some embodiments, the barrier683is instead formed over the opening654in the lid606. In such embodiments, the cover609can be solid and can be used to cover the lid606, for example, after the barrier683has been punctured, or the cover609can include an additional barrier. Alternatively, in embodiments in which the barrier683is formed over the opening654in the lid606, a cover609need not be employed. Whether employed with the lid606or the cover609, or both, or another portion of the sample preparation system600, the barrier683can include the additional functionality of being gas-permeable to allow for gas exchange between the interior of the reservoir622and ambience (e.g., to provide oxygen to aerobic bacteria of interest).

FIG. 13illustrates a sample preparation system700according to another embodiment of the present disclosure.FIG. 13shows only the lid assembly777of the sample preparation system700. The other components of the sample preparation system700can be assumed to include any of the other respective components of the sample preparation systems described above and illustrated inFIGS. 2-12, and thus for simplicity, are not shown inFIG. 13.

The lid assembly777includes a lid706and a cover709coupled to the lid706via a hinge785. In some embodiments, as shown inFIG. 13, the hinge785is a living hinge, and the cover709is integrally formed with the lid706. In some embodiments, the hinge785is formed separately from one or both of the lid706and the cover709. The cover709is a flip-top cover and can be coupled with the lid706via a snap-type engagement. In the embodiment illustrated inFIG. 13, the cover709includes a projection787that can be snapped onto a ridge789on the lid706. The cover709can include other sealing means (e.g., an o-ring), such that when the cover709is closed over the lid706, the cover709forms a seal (e.g., a liquid tight seal, a hermetic seal, etc.) with the lid706.

FIG. 14illustrates a sample preparation and collection system807that includes a sample preparation system800and a sample collection system857. For simplicity,FIG. 14shows only a lid806of the sample preparation system800. The other components of the sample preparation system800can be assumed to include any of the other respective components of the sample preparation systems described above and illustrated inFIGS. 2-13, and thus for simplicity, are not shown inFIG. 14.

The portion of the sample preparation system800that is shown shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and7. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 2-3and7are provided with the same reference numerals in the800series. Reference is made to the description above accompanyingFIGS. 2-3and7for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 14.

As shown inFIG. 14, the sample preparation system800includes a lid806, and the sample collection system857is coupled to the lid806in such a way that the sample collection system857will be positioned in fluid communication with a reservoir of the sample preparation system800that is adapted to contain a liquid composition comprising a source and a diluent. The lid806includes a port832that defines an opening854into the interior of the lid806and the sample preparation system800. The lid806further includes upwardly-extending projections839that can provide additional coupling means for the sample collection system857.

In the embodiment illustrated inFIG. 14, the sample collection system857is coupled to the sample preparation system800via the port832of the lid806and includes a support859that is configured to extend downwardly from the lid806(e.g., to extend into a reservoir of the sample preparation system800) to be in fluid communication with a liquid composition. In some embodiments, the sample preparation system800can include a filter positioned to allow the support859to be in fluid communication with a filtrate of the liquid composition. For example, the sample preparation system800can include a filter designed to retain and hold the liquid composition, similar to the filter234described above and illustrated inFIG. 4, or the filter can be designed to retain the liquid composition in one portion of a reservoir of the sample preparation system800, similar to the filter534described above and illustrated inFIG. 8, such that the support859can extend downwardly from the lid806to be in fluid communication with the filtrate.

The support859can be adapted to capture (e.g., reversibly capture) at least one analyte of interest from a liquid composition (or filtrate), if the analyte of interest is present in the liquid composition via any of the bonds or interactions described below. As mentioned above, a diluent used in the liquid composition can include enrichment media for a specific analyte of interest or the enrichment media can be coated or adsorbed to an inner surface of the sample preparation system800to grow the analyte(s) of interest and, optionally, inhibit the growth of analyte(s) in the liquid composition that are not of interest. The sample preparation and collection system807can further be incubated at a desired temperature to promote the growth of the analyte(s) of interest.

Whether the analyte(s) of interest are enriched or the sample preparation and collection system807is incubated to increase the amount of the analyte(s) of interest in the liquid composition, the support859can be adapted to capture the analyte(s) of interest from the liquid composition. The liquid composition and/or the sample preparation and collection system807(or a portion thereof) can be agitated to facilitate bringing the support859into contact with the liquid composition, or the sample preparation and collection system807can be tipped or inverted to bring the liquid composition into contact with the support859. Furthermore, in embodiments in which the sample preparation system800employs a liner (or a deformable self-supporting receptacle), pressure can be applied to the liner (e.g., positive pressure can be applied to the exterior of the liner or negative pressure can be applied to the interior of the liner) to move the liquid composition into contact with the support859.

In addition, as mentioned above, the liquid composition can be filtered, and the support859can be positioned in fluid communication with the filtrate. In addition, detergent or other cell lysing agents can be added to the diluent or the liquid composition to lyse cells that may be present in the liquid composition, or that may have been produced as a result of enrichment and/or incubation.

The support859can be adapted to capture at least one analyte of interest, such that the sample collection system857provides specific capture of one or more analytes of interest. For example, various moieties can be immobilized (e.g., coated, adsorbed, etc.) onto an outer surface861of the support859that are adapted to bind with one or more analytes of interest. The term “bind” and derivatives thereof generally refers to a variety of chemical bonds or interactions, including, but not limited to, covalent bonds (e.g., polar covalent bonds), ionic bonds, noncovalent bonds, metallic bonds, intermolecular interactions, and combinations thereof. Examples of noncovalent bonds include, but are not limited to, hydrogen bonds (e.g., in complementary nucleic acid sequences), dipole-dipole interactions, van der Waal's forces, electrostatic interactions, hydrophobic interactions, and combinations thereof. Intermolecular interactions can include a variety of the above-described bonds and/or interactions and can include, but are not limited to protein-protein interactions, peptide-peptide interactions, complementary nucleic acid sequences, antigen-antibody complexes, carbohydrate complexes, and combinations thereof.

In some embodiments, the support859can be functionalized with a variety of molecules or moieties including, but not limited to, antibodies, nucleic acid sequences, polysaccharides, carbohydrates, lipids, charged moieties or molecules, peptides, proteins (e.g., avidin/streptavidin, biotin), receptors, and combinations thereof. For example, in the embodiment illustrated inFIG. 14, the support859can include antibodies immobilized to its outer surface861that are capable of forming an antigen-antibody complex withSalmonellaspp. (e.g., the support859can include a 3M™ TECRA®SalmonellaImmunocapture support (available from 3M Microbiology, 3M Company, St. Paul, Minn.)).

In some embodiments employing the port832, as shown inFIG. 14, at least a portion of the support859can be dimensioned to be received in the port832. In the embodiment illustrated inFIG. 14, the support859is generally planar and has a width similar to the diameter of the port832to facilitate coupling the support859to the port832. However, the support859inFIG. 14is shown by way of example only, and one of ordinary skill in the art should understand that the support859can take on a variety of shapes (including a variety of cross-sectional shapes) and forms without departing from the spirit and scope of the present disclosure. For example, the support859can instead be generally cylindrical in shape. In addition, in the embodiment illustrated inFIG. 14, the support859has a length greater than its width to allow it to be positioned in the port832, while allowing it to be able to extend below the bottom of the lid806, and particularly, below a bottom of the lid806that is adapted to be coupled to a container and/or a liner. However, the proportions of the support859are shown inFIG. 14by way of example only, and one or ordinary skill in the art should understand that the support859could instead be coupled to a different portion of the lid806or another component or portion of the sample preparation system800and can include a different shape having different proportions, without departing from the spirit and scope of the present disclosure. For example, in some embodiments, the support859can be coupled to an inner surface of the lid806below the port832, and the support859can be dimensioned more closely to the diameter of a container and/or liner to which the lid806is coupled, rather than being dimensioned to fit in the port832.

Furthermore, in some embodiments, the support859can be hollow, and an inner surface of the support859, in addition to or in lieu of its outer surface861, can be functionalized to capture the analyte(s) of interest. In addition, in some embodiments, the support859can include one or more fluidic channels, a porous material or a collection filter (such as those described in greater detail below).

The support859can be formed of a variety of materials, including, but not limited to, one or more of polymers (e.g., polycarbonate, polyester, etc., combinations thereof), composites, elastomers, porous materials (e.g., cellulosics), ceramics (e.g., ceramic membranes or ceramic membrane filters), any of the materials described above with respect to the filter134, and combinations thereof.

In use, following any of the above-described agitation, enrichment, incubation, lysing, and/or filtering steps, the lid806can be decoupled from the other components of the sample preparation system800, and any analyte(s) of interest that has been collected by the support859can be eluted into a new receptacle, for example, using an elution solution adapted to disrupt the bond or interaction between the analyte(s) of interest and the moieties or molecules immobilized on the support859, or a lysis reagent to lyse cells captured by the support859. A variety of elution solutions known in the art can be used and can be specific to the interaction at hand, or can be a general nonspecific elution solution that is capable of disrupting a variety of bonds and interactions.

Any analyte(s) of interest collected by the support859can be eluted into a new receptacle, device or system for a variety of downstream processes. For example, the analyte(s) of interest can be eluted into a test tube, a centrifugation tube, a flask, a fresh sample preparation system, a culture device, or another receptacle for further processing, including, but not limited to, concentration, incubation, enrichment, analysis, etc. Alternatively, or in addition, the analyte(s) of interest can be eluted into a detection system adapted to identify and/or quantitate the analyte(s) of interest.

In some embodiments, the lid806and the sample collection system857can be coupled to the mating components of another sample preparation system in which the reservoir of a container or liner has been filled with a fresh diluent (e.g., an elution solution and/or enrichment media), such that when the lid806is coupled to the new sample preparation system, the support859is positioned in fluid communication with the reservoir of that sample preparation system and the media contained therein.

Because the support859is functionalized for specific capture of the analyte(s) of interest, the sample collection system857is configured to collect a sample from the sample preparation system800that includes substantially only the analyte(s) of interest. Other contaminants from the liquid composition, particularly contaminants having similar functionalities/moieties as the analyte(s) of interest, may be present in the sample collected, but the sample collection system857is designed to capture substantially only the analyte(s) of interest.

FIG. 15illustrates a sample preparation and collection system907according to another embodiment of the present disclosure, wherein like numerals represent like elements. For simplicity,FIG. 15shows only a lid906of the sample preparation system900. The sample preparation and collection system907shares many of the same elements and features described above with reference to the illustrated embodiment ofFIG. 14. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIG. 14are provided with the same reference numerals in the900series. Reference is made to the description above accompanyingFIG. 14for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 15.

The sample preparation and collection system907includes a sample preparation system900and a sample collection system957coupled to the sample preparation system900, and particularly, to the lid906. The sample collection system957includes a capsule990having a hollow interior991. The sample collection system957further includes one or more magnets993positioned with the interior991of the capsule990. The magnets993can be used to capture analyte(s) of interest that have been magnetized, for example, by being allowed to interact with magnets (e.g., magnetic beads) that are functionalized to bind or interact with the analyte(s) of interest. Examples of suitable magnetic beads or particles include, but are not limited to, DYNAL® DYNABEADS® (Invitrogen, Inc., Carlsbad, Calif.), MAGNABINDO Streptavidin Beads (Pierce Biotechnology, Inc., Rockford, Ill.), etc., and combinations thereof.

Magnets can be used to capture analytes of interest, for example, when paramagnetic beads that have been functionalized with molecule or moieties known to bind or interact with the analyte of interest (e.g., with antibodies, steptavidin, etc.) are added to the source and/or liquid composition. For example, paramagnetic beads that have been functionalized with oligonucleotide capture probes can be added to a liquid composition to capture any nucleic acids having a nucleic acid sequence that is complementary to the probe. The same paramagnetic beads that are capable of capturing the nucleic acids of interest from the liquid composition will be attracted to the magnets993in the capsule990and will be collected from the liquid composition by the sample collection system957. Alternatively, the functionalized paramagnetic beads can first be immobilized against the capsule990by virtue of their magnetic attraction to the magnets993, and then the sample collection system957can be placed in fluid communication with the liquid composition. The collected nucleic acid sequences of interest can then be removed from the sample collection system957(e.g., by elution), transferred to another receptacle, device or system, and/or further processed (e.g., resuspended, concentrated, analyzed, etc.). The capture of nucleic acids is described above by way of example only; however, the magnetic beads can exploit any of the above-described bonds or interactions. For example, in some embodiments, the magnetic beads are functionalized with antibodies and form an antibody-antigen complex with the analyte(s) of interest, and in some embodiments, the magnetic beads form an electrostatic (charge-charge) interaction with the analyte(s) of interest.

The capsule990is shown inFIG. 15as being coupled to a port932of the lid906and as being dimensioned to be received in the port932, and particularly, in an opening954defined in the port932. However, the sample collection system957and the capsule990is shown inFIG. 15by way of example only, and it should be understood that the capsule990can have a variety of sizes and proportions and can be coupled to other portions of the lid906or other components of the sample preparation system900without departing from the spirit and scope of the present disclosure.

In use, the liquid composition and/or the sample preparation and collection system907can be agitated to facilitate bringing the liquid composition into contact with the sample collection system957. The sample preparation and collection system907can also be tipped or inverted to bring the liquid composition into contact with the sample collection system957. Furthermore, in embodiments in which the sample preparation system900employs a liner (or a deformable self-supporting receptacle), pressure can be applied to the liner (e.g., positive pressure can be applied to the exterior of the liner or negative pressure can be applied to the interior of the liner) to move the liquid composition into contact with the capsule990of the sample collection system957.

Because the capsule990is adapted for magnetic capture of the analyte(s) of interest, the sample collection system957is configured to collect a sample from the sample preparation system900that includes substantially only the analyte(s) of interest. Other contaminants from the liquid composition, particularly contaminants having similar functionalities/moieties as the analyte(s) of interest (e.g., that may have become magnetized), may be present in the sample collected, but the sample collection system957is designed to capture substantially only the analyte(s) of interest.

In addition, in the embodiment illustrated inFIG. 15, the capsule990includes two closed ends. However, in some embodiments, the capsule990includes an open upper end, such that the interior991of the capsule990can be accessed for positioning of and removal of the magnets993. Furthermore, in some embodiments, the magnets993are electromagnets, and the magnets are coupled (e.g., via an open upper end of the capsule990) to an electrical circuit. In some embodiments, the magnets993comprises rare-earth magnets. In embodiments employing a capsule990having an open upper end, the sample preparation and collection system907can include a cover (not shown) that can be dimensioned to be coupled to the open upper end of the capsule990via any of the above-described removable, permanent or semi-permanent coupling means. In some embodiments, the sample collection system957functions by employing magnets, but does not include a capsule990. That is, in some embodiments, the sample collection system957includes a magnet that is coupled to a portion of the sample preparation system900without being contained within any type of capsule.

The capsule990can be formed of a variety of materials, including, but not limited to, one or more of polymers, metals (e.g., non-magnetic metals), ceramics, composites, glass, elastomers, and combinations thereof.

FIG. 16illustrates a sample preparation and collection system1007that includes a sample preparation system1000and a sample collection system1057. For simplicity,FIG. 16shows only a cover1009of the sample preparation system1000. The other components of the sample preparation system1000can be assumed to include any of the other respective components of the sample preparation systems described above and illustrated inFIGS. 2-13, and thus for simplicity, are not shown inFIG. 16. However, by way of example only, the sample preparation system1000can be assumed to be the same as that of the sample preparation system600described above and illustrated inFIGS. 9-12.

The sample collection system1057includes one or more antibodies1094that are coupled to the cover1009of the sample preparation system1000. Particularly, in the embodiments illustrated inFIG. 16, the antibodies1094have been coupled to (i.e., immobilized onto) an inner surface1011of the cover1009. The antibodies1094can be adapted to form an antigen-antibody complex with the analyte(s) of interest, and the sample collection system1057can be positioned in fluid communication with a reservoir of the sample preparation system1000when the cover1009is coupled to a lid, a container, and/or a liner of the sample preparation system1000.

In use, the sample preparation and collection system1007can be used to prepare a liquid composition comprising a source and a diluent, and the sample preparation and collection system1007can be closed with the cover1009of the sample preparation system1000to position the sample collection system1057in fluid communication with a reservoir of the sample preparation system1000containing the liquid composition, such that the antibodies1094can capture the analyte(s) of interest from the liquid composition, or a filtrate thereof. For example, a filter similar to that of the filter634described above and illustrated inFIGS. 9-11can be employed in the sample preparation system1000to pre-filter the liquid composition.

Because the antibodies1094are adapted for specific capture of the analyte(s) of interest, the sample collection system1057is configured to collect a sample from the sample preparation system1000that includes substantially only the analyte(s) of interest. Other contaminants, particularly contaminants having similar functionalities/moieties as the analyte(s) of interest, may be present in the sample collected, but the sample collection system1057is designed to capture substantially only the analyte(s) of interest.

In addition, the liquid composition and/or the sample preparation and collection system1007can be agitated to facilitate bringing the liquid composition into contact with the sample collection system1057. In addition, the sample preparation and collection system1007can be tipped or inverted to bring the liquid composition into contact with the sample collection system1057. Furthermore, in embodiments in which the sample preparation system1000employs a liner, pressure can be applied to the liner (e.g., positive pressure can be applied to the exterior of the liner or negative pressure can be applied to the interior of the liner) to move the liquid composition into contact with the antibodies1094of the sample collection system1057.

After the liquid composition has been allowed to interact with the antibodies1094of the sample collection system1057, the cover1009can be removed from the remainder of the sample preparation system1000, and any captured analyte(s) of interest can be removed from the antibodies1094of the sample collection system1057(e.g., by elution), transferred to another receptacle, device or system, and/or further processed (e.g., resuspended, concentrated, enriched, incubated, analyzed, lysed, etc.).

The sample collection system1057, and particularly, the antibodies1094are illustrated inFIG. 16as being coupled to the inner surface1011of the cover1009. However, it should be understood that the antibodies1094can be instead be coupled to one or more of the other components of the sample preparation system1000without departing from the spirit and scope of the present disclosure.

As mentioned above,FIG. 17illustrates a sample preparation and collection system1107according to one embodiment of the present disclosure. The sample preparation system1100shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and7. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 2-3and7are provided with the same reference numerals in the1100series. Reference is made to the description above accompanyingFIGS. 2-3and7for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 17.

The sample collection system1157is coupled to the sample preparation system1100, such that the sample collection system1157is in fluid communication with the sample preparation system1100, and such that a fluid path1192is defined at least partially by the sample preparation system1100and the sample collection system1157. The fluid path1192allows a liquid composition, its filtrate, or a portion of the liquid composition or filtrate to be moved from the sample preparation system1100to the sample collection system1157by moving in the fluid path1192and not being exposed to ambience during the transfer between the sample preparation system1100and the sample collection system1157.

In the sample preparation and collection systems807,907and1007described above and illustrated inFIGS. 14-16, the sample collection system857,957,1057is positioned to be in fluid communication with a reservoir of the sample preparation system800,900,1000, such that a fluid path can be thought to be at least partially defined by the sample preparation system800,900,1000and the respective sample collection system857,957,1057. However, because the sample collection system857,957,1057is generally positioned within the interior of the sample preparation system800,900,1000, transfer of a sample from the sample preparation system800,900,1000to the respective sample collection system857,957,1057is not necessarily required. Still, the sample preparation and collection systems807,907and1007can also be thought to provide means for preparing and collecting a sample without necessarily exposing the sample to ambience, or at least not until after the collection process.

In some embodiments, the phrase “without exposing to ambience” and derivations thereof refers to not removing a sample (i.e., at least a portion of the liquid composition or filtrate) during the transfer between the sample preparation system and the sample collection system (e.g., to prevent spills or contamination), such that the sample remains in the fluid path1192of the sample preparation and collection system1107from preparation to collection, or even to another downstream step, but does not necessarily mean that the sample preparation and collection system1107is closed to gas-exchange or that other liquids cannot get into the sample preparation and collection system1107. For example, in some embodiments, a lid, a cover, a container and/or a liner, or a portion thereof, is gas-permeable, or includes a gas-permeable film or membrane (e.g., for aerobic bacteria to continue to have access to oxygen).

In some embodiments, a plurality of sample preparation systems1100can be coupled to and in fluid communication with the same sample collection system1157, such that samples from the plurality of sample preparation systems1100are pooled together prior to collection or any downstream analysis or further processing.

The sample preparation system1100includes a container1102having a first reservoir1120, a liner1104having a second reservoir1122and dimensioned to be received in the first reservoir1120of the container1102, and a lid1106. The sample preparation system1100can also include a collar (not shown) to further secure the components of the sample preparation system1100together. The second reservoir1122is adapted to contain a liquid composition1114comprising a source1112and a diluent1113.

The lid1106includes two upwardly-extending projections1139to which the sample collection system1157is coupled. The lid1106further includes a port which is substantially similar to the port432described above and illustrated inFIG. 7and which is not shown inFIG. 17, because the sample collection system1157is coupled to the lid1106of the sample preparation system1100and, particularly, is coupled over the port and to the upwardly-extending projections1139of the lid1106. The lid1106further includes a filter1134that is substantially similar to the filter334shown inFIGS. 5-6and described above. The filter1134is adapted to filter the liquid composition1114to form a filtrate1116that comprises the analyte of interest (if present). However, it should be understood that the filter1134can take on any of the previously-described forms instead.

As shown inFIG. 17, the sample collection system1157is shaped and dimensioned to be coupled to the port and the upwardly-extending projections1139of the lid1106. The sample collection system1157is shown in greater detail inFIG. 18. The sample collection system1157includes a housing1196, an inlet1186, and an outlet1188. The housing1196includes a first portion1196a, a second portion1196b, and a third portion1196c. The first, second and third portions1196a,1196band1196ccan be coupled together by any of the above-described coupling means, or two or more of the first, second and third portions1196a,1196band1196ccan be integrally formed. The housing1196includes a bore1197and an inner surface1198, each of which is defined at least partially by the first portion1196aand the second portion1196bof the housing1196.

The third portion1196cincludes one or more apertures1182in fluid communication with the bore1197and a seat1199positioned upstream of the apertures1182in which a collection filter1184can be positioned. Alternatively, the seat1199can be formed between the third portion1196cand the second portion1196b. The collection filter1184can be sized and/or functionalized to collect the analyte(s) of interest. In addition, a filter support (e.g., a mesh, such as a wire mesh, or other similar structure) can be positioned in the seat1199to support the collection filter1184and inhibit the collection filter1184from being displaced from the seat1199during operation. The filter support can also include a plurality of pores or apertures so as not to significantly disrupt the fluid flow through the sample collection system1157. In some embodiments in which the collection filter1184is adapted to collect the analyte(s) of interest based on size, the collection filter1184can have an average pore size of less than 1 μm.

In some embodiments, the third portion1196cis removably coupled to the second portion1196bto allow the collection filter1184to be removed from the sample collection system1157, e.g., to retrieve the collected analyte(s) of interest, to replace the collection filter1184, etc. In the embodiment illustrated inFIG. 18, the third portion1196cis coupled to the second portion1196bvia a screw-type engagement, and an inner surface of the third portion1196cand an outer surface of the second portion1196binclude mating threads. However, it should be understood that the third portion1196ccan be coupled to the second portion1196busing any of the above-described coupling means.

The inner surface1198of the housing1196can be coupled to the port of the sample preparation system1100by any of the coupling means described above, for example, by press-fit engagement with. By way of example, the port can include one or more ridges similar to the ridges441described above and illustrated inFIG. 7to facilitate a press-fit or snap-fit engagement with the inner surface1198of the housing1196. Alternatively, or in addition, the inner surface1198can include one or more mating structures, such as ribs or ridges to matingly engage with the outer surface (and/or any coupling structures formed thereon) of the port of the lid1106.

The housing1196further includes one or more projections or threads1195adapted to allow the sample collection system1157to be screwed onto the port of the sample preparation system1100and secured underneath a radially-inwardly projecting portion of each of the projections1139of the lid1106. The embodiment illustratedFIGS. 17 and 18includes two threads spaced apart circumferentially to allow the sample collection system1157to be moved downwardly over the port of the lid1106(e.g., with both of the threads1195positioned out of contact with the projections1139) and then rotated with respect to the lid1106to allow each of the radially-inwardly projecting portions of the projections1139to cam along an upper surface of one of the threads1195until the sample collection system1157is secured under the projections1139of the lid1106(e.g., such that the sample collection system1157is inhibited from being pulled from the sample preparation system1100, and from being rotated either relative to the sample preparation system1100any further in the same direction, or in the opposite direction without sufficient force).

The housing1196can be formed of a variety of materials, including any of the materials listed above with respect to the container102and the collar108.

The bore1197and the apertures1182define at least a portion of the fluid path1192, such that the inlet1186can be in fluid communication with the sample preparation system1100. The container1102of the sample preparation system1100includes a base1127, and an aperture1124defined in the base1127. Pressure can be applied to the liner1104(e.g., positive pressure can be applied to the exterior of the liner1104(e.g., to a base1126of the liner1104, e.g., via the aperture1124in the base1127of the container1102) or negative pressure can be applied to the interior of the liner1104) to move the liquid composition through the filter1134and into the sample collection system1157. In embodiments employing the filter1134, the filter1134can function as a pre-filter to remove unwanted relatively large insoluble matter (e.g., large particles or debris) from the liquid composition1114. Pre-filtering the liquid composition1114can be advantageous to enhance the purity of the material passing through the sample collection system1157and enhance the capture of the analyte(s) of interest. In addition, pre-filtering can help avoid clogging any portion of the sample collection system1157or other downstream devices, but pre-filtering is not necessary, and in some embodiments, the liquid composition1114will be moved into the sample collection system1157without being pre-filtered.

In some embodiments, negative pressure can be applied to the interior (e.g., the second reservoir1122) of the liner1104by applying a vacuum to the outlet1188of the of the sample collection system1157, which can be accomplished by fluidly coupling the third portion1196cof the housing1196to a vacuum source, such as mechanical pump that creates a reduced pressure, or a manual pump such as a syringe-plunger combination. When negative pressure is applied to the outlet1188of the sample collection system1157, the liquid composition1114is moved through the filter1134(optionally) to form a filtrate1116, and the filtrate1116is forced through the sample collection system1157, particularly, through the bore1197and the apertures1182. As the filtrate1116passes through the collection filter1184, the analyte(s) of interest can be trapped in the collection filter1184, and the portions of the filtrate1116that are not trapped by the collection filter1184can pass through the collection filter1184, and optionally to waste or another receptacle. For example, the housing1196can be fluidly coupled to a vacuum source via a receptacle adapted to collect the portions of the filtrate1116that pass through the collection filter1184. The sample preparation system1100can further include an aperture1158which can function as a vent during suction, or to which a port or valve can be coupled. Alternatively, the liner1104can deform in response to the negative pressure and the suction can continue until the liner1104has collapsed.

In some embodiments, the sample collection system1157, or at least a portion thereof, can be coupled to another portion of the sample preparation system1100, such as the base1127of the container1102(e.g., via the aperture1124in the base1127; such embodiments may not employ a liner1104). In such embodiments, at least a portion of the container1102can be removable to facilitate coupling the sample collection system1157to the sample preparation system1100and/or removing the sample collection system1157, or a portion thereof (e.g., the collection filter1184).

In some embodiments, one or more portions or components of the sample preparation and collection system1107can include means for agitating the liquid composition1114and/or the filtrate1116. For example, in some embodiments, the lid1106, the container1102and/or the liner1104can include one or more means for agitating the liquid composition. By way of example only, in some embodiments, the sample preparation and collection system1107can include a first lid (or other removable portion of the sample preparation system1100) that includes means for agitating the liquid composition1114, and a second lid1106, as shown inFIG. 17, that can be coupled to the sample collection system1157. In such embodiments, the first lid can be coupled to the container1102and/or the liner1104to agitate the liquid composition1114, and then the first lid can be replaced with the second lid1106ofFIG. 17to collect one or more analytes of interest.

In some embodiments, the sample collection system1157can be positioned at one end of the sample preparation and collection system1107(e.g., at the lid1106or the base1127of the container1102of the sample preparation system1100), and means for agitating the liquid composition1114(and/or the filtrate1116) can be positioned at another (e.g., opposite) end. In such embodiments, the liquid composition1114(and/or the filtrate1116) can be agitated by orienting the sample preparation and collection system1107in a first orientation (e.g., toward blending blades), and the sample preparation and collection system1107can then be oriented in a second orientation (e.g., inverted) to move at least a portion of the liquid composition1114(or filtrate1116) in the fluid path1192to the sample collection system1157. Such an embodiment is illustrated inFIG. 26and described in greater detail below.

As mentioned above, the collection filter1184can be sized and/or functionalized to collect the analyte(s) of interest. As a result, the collection filter1184can be adapted for specific or non-specific collection of the analyte(s) of interest. In some embodiments, the collection filter1184can include a depth filter. The collection filter1184can be formed of a variety of materials, including those listed above with respect to the filter134shown inFIGS. 2-3, and additionally including, but not limited to, carbon, particle-loaded materials (e.g. 3M™ EMPORE™ solid phase extraction products (3M Company, St. Paul, Minn.)), and combinations thereof. The collection filter1184can include a variety of filter types, including, but not limited to, depth filters, surface filters, membrane filters, or the like, or combinations thereof.

In embodiments in which the collection filter1184is functionalized to bind or interact with the analyte(s) of interest, the sample collected by the sample collection system1157, and particularly by the collection filter1184, can include substantially only the analyte(s) of interest. However, in embodiments in which the collection filter1184is not functionalized, and the analyte(s) of interest are collected nonspecifically (e.g., by size and/or charge), the sample collected by the collection filter1184may not necessarily include substantially only the analyte(s) of interest, but rather may include other material from the liquid composition1114from which the analyte(s) of interest can be isolated in subsequent processing steps (e.g., enrichment, incubation, inoculation, etc.).

FIGS. 19-20illustrate a sample collection system1257according to another embodiment of the present disclosure. The sample collection system1257shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 17-18. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 17-18are provided with the same reference numerals in the1200series. Reference is made to the description above accompanyingFIGS. 17-18for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIGS. 19-20.

The sample collection system1257functions similarly to the sample collection system1157described above. The sample collection system1257includes a housing1296, an inlet1286and an outlet1288. The housing1296includes projections or threads1295that are adapted to be coupled to a lid of a sample preparation system, and particularly, to projections of the lid. The housing1296includes a bore1297and an inner surface1298. The inner surface1298can be coupled to a port of a lid of a sample preparation system to couple the inlet1286of the sample collection system1257to a sample preparation system and position the bore1297in fluid communication with a reservoir of the sample preparation system.

The housing1296includes a chamfered portion1296awhich can facilitate coupling of the sample collection system1257with other devices (e.g. a vacuum source). The bore1297of the housing1296narrows toward the outlet1288to form an upper portion1297aof the bore1297that has a smaller diameter, and which can form a seat in which a collection filter1284(not shown inFIG. 20) can be positioned. As shown inFIG. 20, a plurality of channels1293are defined in the inner surface1298at the top of the housing1296, and the housing1296further includes a port1294that defines an aperture or bore1282(shown inFIG. 20) which can function as the outlet1288of the sample collection system1257. The channels1283facilitate fluid flow from the collection filter1284to the aperture1282. In the embodiment illustrated inFIGS. 19-20, the sample collection system1257includes three diametric channels1283spaced equally about the central aperture1282; however, a variety of other channel configurations suitable for facilitating fluid flow from the collection filter1284to the aperture1282can be employed without departing from the spirit and scope of the present disclosure.

The bore1297, the channels1293, and the aperture1282define at least a portion of a fluid path1292(shown inFIG. 20), such that the inlet1286can be in fluid communication with a sample preparation system. In some embodiments, negative pressure can be applied to the outlet1288of the of the sample collection system1257(e.g., by fluidly coupling at least a portion of the housing1296to a vacuum source). When negative pressure is applied to the outlet1288of the sample collection system1257, a liquid composition can be moved into the sample collection system1257(or the liquid composition can be moved through a pre-filter to form a filtrate, and the filtrate can be forced through the sample collection system1257), particularly, through the bore1297, the collection filter1284, the aperture1282and possibly, the channels1293. As the liquid composition (or filtrate) passes through the collection filter1284, the analyte(s) of interest can be trapped in the collection filter1284, and the portions of the liquid composition (or filtrate) that are not trapped by the collection filter1284can pass through the collection filter1284, and optionally to waste or another receptacle. The collection filter1284can be sized, charged and/or functionalized to collect the analyte(s) of interest.

FIGS. 21-22illustrate a sample preparation and collection system1307according to another embodiment of the present disclosure, the sample preparation and collection system1307including a sample preparation system1300and a sample collection system1357. The sample preparation system1300share many of the same elements and features described above with reference to the illustrate embodiment ofFIGS. 9-12, and the sample collection system1357shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 17-18. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 9-12and17-18are provided with the same reference numerals in the1300series. Reference is made to the description above accompanyingFIGS. 9-12and17-18for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIGS. 21-22.

The sample preparation system1300includes a lid1306and a cover1309substantially similar to that described above with respect toFIGS. 9-12, except that the cover1309does not include a frangible barrier. The cover1309includes an upper wall1310and an aperture1382defined in the upper wall1310. The lid1306includes a port1332that defines at least a portion of a bore1397that can be positioned in fluid communication with a reservoir of a sample preparation system by coupling the lid1306to a container and/or liner of the sample preparation system. The cover1309can be coupled to the lid1306via any of the above-described coupling means and is shown as being removably coupled to the lid1306via a screw-type engagement by way of example only.

The sample collection system1357includes a collection filter1384that can be coupled between the cover1309and an upper surface of the port1332of the lid1306, as shown inFIGS. 21-22, such that the collection filter1384is positioned in fluid communication with the bore1397of the lid1306and a reservoir (not shown) of the sample preparation system1300. All of the components shown inFIGS. 21-22are considered to form a portion of the sample preparation and collection system1307, and the cover1309and the lid1306are described as being a portion of the sample preparation system1300by way of example only. In some embodiments, the cover1309and the lid1306can be thought of as a portion of the sample collection system1357that is coupled to a sample preparation system (e.g., a container and/or a liner/deformable self-supporting receptacle), and in such embodiments, the sample collection system1357can define an inlet1386and an outlet1388of the sample collection system1357.

The bore1397in the lid1306and the aperture1382in the cover1309define at least a portion of a fluid path1392(shown inFIG. 22), such that the inlet1386can be in fluid communication with a sample preparation system. In some embodiments, negative pressure can be applied to the outlet1388of the of the sample collection system1357(e.g., by fluidly coupling at least a portion of the cover1309and/or the lid1306to a vacuum source). When negative pressure is applied to the outlet1388, a liquid composition can be moved into the bore1397(or the liquid composition can be moved through a pre-filter to form a filtrate, and the filtrate can be moved into the bore1397), through in the lid1306, the collection filter1384, and the aperture1382in the cover1309.

As the liquid composition (or filtrate) passes through the collection filter1384, the analyte(s) of interest can be trapped in the collection filter1384, and the portions of the liquid composition (or filtrate) that are not trapped by the collection filter1384can pass through the collection filter1384, and optionally to waste or another receptacle. The collection filter1384can be sized, charged and/or functionalized to collect the analyte(s) of interest.

FIGS. 23-24illustrate a sample collection system1457according to another embodiment of the present disclosure. The sample collection system1457shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 17-18. Accordingly, elements and features corresponding to elements and features in the illustrated embodiment ofFIGS. 17-18are provided with the same reference numerals in the1400series. Reference is made to the description above accompanyingFIGS. 17-18for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIGS. 23-24.

The sample collection system1457functions similarly to the sample collection system1157described above. The sample collection system1457includes a housing1496, an inlet1486and an outlet1488. The housing1496includes a first portion1496a, a second portion1496b, and a third portion1496c. The first portion1496a, the second portion1496b, and the third portion1496ccan be coupled via any of the above-described coupling means but the first and second portions1496aand1496bare shown inFIG. 24as being removably coupled via a screw-type engagement by way of example only. Particularly, in the embodiment illustrated inFIGS. 23-24, the second portion1496bis adapted to receive at least an upper portion of the first portion1496aof the housing1496, and each of the first portion1496aand the second portion1496binclude mating threads to allow the second portion1496bto be screwed down over at least an upper portion of the first portion1496aof the housing1496. In addition, the second portion1496bincludes an aperture1454dimensioned to received a least a portion of the third portion1496cof the housing1496, as shown inFIG. 23.

The first portion1496aof the housing1496includes a base1490with two opposing flat faces1491and two opposing cylindrical projections1495. The base1490is adapted to be coupled to a lid of a sample preparation system, and particularly, to a port and projections of the lid. The housing1496includes a bore1497and an inner surface1498defined at least partially by the first and third portions1496aand1496cof the housing1496. The inner surface1498can be coupled to a port of a lid of a sample preparation system to couple the inlet1486of the sample collection system1457to a sample preparation system and position the bore1497in fluid communication with a reservoir of the sample preparation system. Particularly, the base1490of the first portion1496aof the housing1496can be dimensioned to receive the port of the lid, and the inner surface1498can be coupled to an outer surface of the port of the lid. In addition, the sample collection system1457can be moved downwardly into position over the port of the lid (e.g., with both of the cylindrical projections1495positioned out of contact with the projections1139) and then rotated with respect to the lid to position the cylindrical projections1495under radially-inwardly projecting portions of projections on the lid (e.g., similar to the projections1139shown inFIG. 17), for example, to inhibit the sample collection system1457from being pulled from the sample preparation system.

The third portion1496cof the housing1496includes a base structure similar to that of the base1490of the first portion1496a, such that the base structure of the third portion1496ccan be dimensioned to receive an upper portion of the first portion1496aof the housing1496and can be coupled between the first and second portions1496aand1496bwhen the second portion1496bis coupled to the first portion1496a. The first portion1496aof the housing1496defines the inlet1486to the sample collection system1457, and the third portion1496cincludes a port that defines an aperture1482that functions as the outlet1488of the sample collection system1457. A collection filter1484can be positioned at the junction between the main body of the third portion1496cand the port. As shown inFIG. 23, the collection filter1484is dimensioned to fit at the entrance to the port. Alternatively, however, the collection filter1484can be positioned at the base of the main body of the third portion1496cand can be dimensioned more closely to the bore1497through the main body, rather than to that of the port. In addition, at least a portion of the inner surface1498in the third portion1496cof the housing1496can include channels (e.g., similar to the channels1293described above and illustrated inFIG. 20) positioned behind (i.e., downstream) of the collection filter1484to facilitate fluid flow between the collection filter1484and the aperture1482.

The bore1497and the aperture1482define at least a portion of a fluid path1492(shown inFIG. 24), such that the inlet1486can be in fluid communication with a sample preparation system. In some embodiments, negative pressure can be applied to the outlet1488of the of the sample collection system1457(e.g., by fluidly coupling at least a portion of the housing1496to a vacuum source). When negative pressure is applied to the outlet1488of the sample collection system1457, a liquid composition can be moved into the sample collection system1457(or the liquid composition can be moved through a pre-filter to form a filtrate, and the filtrate can be forced through the sample collection system1457), particularly, through the bore1497, the collection filter1484, and the aperture1482. As the liquid composition (or filtrate) passes through the collection filter1484, the analyte(s) of interest can be trapped in the collection filter1484, and the portions of the liquid composition (or filtrate) that are not trapped by the collection filter1484can pass through the collection filter1484, and optionally to waste or another receptacle. The collection filter1484can be sized, charged and/or functionalized to collect the analyte(s) of interest.

In the embodiment illustrated inFIGS. 23-24and by way of example only, the first and second portions1496aand1496bare formed of metal, and particularly, of stainless steel, and the third portion1496cis formed of a translucent polymeric material, and particularly, of polypropylene. Forming the third portion1496cof a more transparent or translucent material can facilitate visualization of a collected sample. However, these materials are illustrated by way of example only, and one or ordinary skill in the art should understand that the first, second, and third portions1496a,1496band1496cof the housing1496can be can be formed of a variety of materials, including those listed above with respect to the container102or the collar108. One or more of the portions1496a,1496b,1496ccan be formed of the same or a different material.

After the liquid composition (or filtrate) has passed through the sample collection system1457, and the collection filter1484has been allowed to capture any analyte(s) of interest, the second portion1496bof the housing1496can be decoupled from the first portion1496aof the housing1496, and the third portion1496ccomprising the collection filter1484and the collected sample (and any captured analyte(s) of interest) can be removed from the sample collection system1457. The collection filter1484can be removed from the third portion1496cfor further processing and/or analysis, or the third portion1496citself can be transferred to another device for concentration, enrichment, incubation, analysis (e.g., a detection device), etc. For example, the third portion1496ccan be placed in a tube containing enrichment media, and following enrichment of the captured analyte, a sample can be added to a tube strip, which can then be positioned in automated processing equipment adapted to automatically handle the tube strip and add any necessary reagents for further processing, etc. (e.g. an enriched sample can be placed in the receiving tube (“SPR”) of a VIDAS® instrument (VIDAS, bioMerieux, Hazelwood, Mo.)).

FIG. 25illustrates a sample preparation and collection system1507according to another embodiment of the present disclosure. The sample preparation system1500shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and7. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 2-3and7are provided with the same reference numerals in the1500series. Reference is made to the description above accompanyingFIGS. 2-3and7for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 25.

The sample preparation and collection system1507includes a sample preparation system1500and a sample collection system1557. The sample collection system1557is coupled to the sample preparation system1500, such that the sample collection system1557is in fluid communication with the sample preparation system1500, and such that a fluid path1592is defined at least partially by the sample preparation system1500and the sample collection system1557. The fluid path1592allows a liquid composition, its filtrate, or a portion of the liquid composition or filtrate to be moved from the sample preparation system1500to the sample collection system1557by moving in the fluid path1592and not being exposed to ambience during the transfer between the sample preparation system1500and the sample collection system1557.

The sample preparation system1500includes a container1502having a first reservoir1520, a liner1504having a second reservoir1522and dimensioned to be received in the first reservoir1520of the container1502, and a lid1506. The sample preparation system1500can also include a collar (not shown) to further secure the components of the sample preparation system1500together. The second reservoir1522is adapted to contain a liquid composition1514comprising a source1512and a diluent1513.

The lid1506includes a first aperture1558aand a second aperture1558b. The sample collection system1557includes an inlet1586, defined by a first conduit1594aand an outlet1588defined by a second conduit1594b. The sample collection system1557further includes a flow cell1591which can include any of the above sample collection elements or features described in the embodiments above to capture the analyte(s) of interest via any of the above described bonds or interactions, including, but not limited to, magnets, immobilized molecules or moieties (e.g., antibodies and/or oligonucleotides), a collection filter that can be sized, charged and/or functionalized, etc., and combinations thereof.

The first and second conduits1594aand1594bare coupled to the lid1506of the sample preparation system1500via the first and second apertures1558aand1558b, respectively, using standard fluid connectors. At least a portion of the fluid path1592is defined by the first and second conduits1594aand1594bof the sample collection system1557. A variety of tubing and connectors known to those of ordinary skill in the art can be used to fluidly couple the flow cell1591of the sample collection system1557to the sample preparation system1500.

In the embodiment illustrated inFIG. 25, the liquid composition1514can be recirculated in the sample preparation system1500. That is, the liquid composition1514can be moved from the second reservoir1522into the inlet1586of the sample collection system1557, through the first conduit1594a, into the flow cell1591, and any analyte(s) of interest can be captured from the liquid composition as the liquid composition is moved through the flow cell1591. The liquid composition (e.g., minus some captured analyte(s) of interest, if present) can then be moved into the second conduit1594bout the outlet1588of the sample collection system1557, and back into the second reservoir1522of the liner1504. The liquid composition1514can continue to be recirculated between the sample preparation system1500and the sample collection system1557in this manner to enhance the removal and collection of any analyte(s) of interest. Furthermore, the flow cell1591or any portion of the fluid path1592can include enrichment media (e.g., coated or adsorbed onto an inner surface of a structure that defines at least a portion of the fluid path1592).

The liquid composition1514can be moved between the sample preparation system1500and the sample collection system1557in a variety of ways. In some embodiments, the flow cell1591is coupled to or is part of a mechanical pump (e.g., a peristaltic pump), which can drive the movement of the liquid composition1514. In some embodiments, the liner1504can be deformed to encourage the movement of the liquid composition1514from the sample preparation system1500and can be returned to its original shape as the liquid composition1514returns to the sample preparation system1500, and so on. The liner1504can be deformed in any of the above-described ways, including applying positive pressure to exterior of the liner1504(e.g., manually by hand, manually with another device such as a plunger, or automatically with a another device), and the exterior of the liner1504(e.g., the base1526of the liner1504) can be accessed, for example, via an aperture1524in a base1527of the container1502. Alternatively, or in addition, negative pressure can be applied to the interior of the liner1504, e.g., by fluidly coupling a vacuum source to the sample collection system1557and the second reservoir1522of the liner1504. The vacuum source can be any of those described above, including, but not limited to, mechanical pumps, manual devices (e.g., a syringe-plunger combination), etc., and combinations thereof.

The sample preparation and collection system1507can further include a pre-filter (not shown) similar to any of the above-described filters (e.g., one or more of filters134,234,334, etc.) positioned in the fluid path1592. For example, one or more filters (e.g., similar to the filter134ofFIGS. 2-3, a planar filter, a foam, a sponge, etc., and combinations thereof) can be dimensioned to be coupled to or within the first conduit1594aat a variety of locations, including the inlet end, the outlet end, or at some location between the inlet and the outlet of the first conduit1594a. By way of further example, a filter substantially similar to that of the filter234or the filter534can be positioned in the second reservoir1522, such that the source1512is contained by the filter, and the filtrate can be positioned outside of (e.g., and in fluid communication with), the filter in the second reservoir1522to be recirculated.

In the embodiment illustrated inFIG. 25, the flow cell1591includes one or more magnets (not shown) which can function similarly to the magnets993described above and illustrated inFIG. 15(e.g., to attract functionalized paramagnetic beads). The liquid composition1514can come into direct contact with the magnets and/or magnetic beads in the flow cell1591, or the magnets can be positioned inside some type of capsule, similar to the capsule990described above and illustrated inFIG. 15.

FIG. 26illustrates a sample preparation and collection system1607according to another embodiment of the present disclosure. The sample preparation and collection system1607includes a sample preparation system1600and a sample collection system1657. The sample preparation system1600shares many of the same elements and features described above with reference to the illustrated embodiments ofFIGS. 2-3and7; and the sample collection system1657shares many of the same elements and features described above with reference to the illustrated embodiment ofFIGS. 21-22. Accordingly, elements and features corresponding to elements and features in the illustrated embodiments ofFIGS. 2-3,7,21and22are provided with the same reference numerals in the1600series. Reference is made to the description above accompanyingFIGS. 2-3,7,21and22for a more complete description of the features and elements (and alternatives to such features and elements) of the embodiment illustrated inFIG. 26.

The sample collection system1657is coupled to the sample preparation system1600, such that the sample collection system1657is in fluid communication with the sample preparation system1600, and such that a fluid path1692is defined at least partially by the sample preparation system1600and the sample collection system1657. The fluid path1692allows a liquid composition, its filtrate, or a portion of the liquid composition or filtrate to be moved from the sample preparation system1600to the sample collection system1657by moving in the fluid path1692without necessarily being exposed to ambience during the transfer between the sample preparation system1600and the sample collection system1657.

As shown inFIG. 26, the sample preparation system1600includes a lid1606and a container1602that defines a reservoir1620. The sample preparation and collection system1607further includes an agitation system1680coupled to the lid1606of the sample preparation system and positioned in the fluid path1692and in fluid communication with the reservoir1620when the lid1606is coupled to the container1602. The agitation system1680shown inFIG. 26includes one or more blades1681rotatable about an axis and positioned to agitate (e.g., blend) a liquid composition in the sample preparation and collection system1607(e.g., in the container1602) when the lid1606is coupled to the container1602. In some embodiments, the agitation system1680can be adapted to be connected to a power source or can include a power source. In some embodiments, the agitation system1680can be adapted to be driven by an external drive (e.g., an external motor, rotor, etc. to which the agitation system1680can be coupled to cause the blades to rotate about a central axis and into contact with the liquid composition). The blades1681are illustrated by way of example only; however, it should be understood that any means for performing any of the above-described agitation methods can be employed in the agitation system1680instead of or in addition to the blades1681. By way of example only, the agitation system1680can include a blending device similar to the blending device of U.S. Pat. Nos. D532,253, 6,338,569, 6,854,875, 7,147,365, 7,168,845, and 7,309,156, each of which is incorporated herein by reference.

The container1602includes a base1627and an aperture1624formed therein. In some embodiments, as shown inFIG. 26, the sample collection system1657can be coupled to the container1602via the aperture1624. Particularly, the sample collection system1657includes or is coupled to a port1632that is in fluid communication with the interior of the container1602via the aperture1624. The sample collection system1657further includes a collection filter1684adapted to be coupled to the port1632. The collection filter1684can be secured to the port1632(and therefore to the container1602) with a cover1609. The cover1609includes an upper wall1610and an aperture1682defined in the upper wall1610. The cover1609can be coupled to the port1632via any of the above-described coupling means and is shown as being removably coupled to the port1632via a screw-type engagement by way of example only.

The collection filter1684can be coupled between the cover1609and an upper surface of the port1632of the lid1606, such that the collection filter1684is positioned in fluid communication with the reservoir1620of the sample preparation system1600. The cover1609, the collection filter1684and the port1632are shown and described as being a part of the sample collection system1657; however, in some embodiments, the sample collection system1657can also include a lower portion of the container1602, the aperture1624and the base1627, and in some embodiments, the sample collection system1657can include the collection filter1684and the other components can form a portion of the sample preparation system1600. Such categorization of components or parts is not critical, and all components shown inFIG. 26can instead form a portion of the sample preparation and collection system1607. In the embodiment illustrated inFIG. 26, the sample collection system1657includes an inlet1686and an outlet1688of the sample collection system1357.

The port1632coupled to or forming the base1627of the container1602and the aperture1682in the cover1609define at least a portion of a fluid path1692, such that the inlet1686can be in fluid communication with the sample preparation system1600. In some embodiments, negative pressure can be applied to the outlet1688of the of the sample collection system1657(e.g., by fluidly coupling at least a portion of the cover1609to a vacuum source). When negative pressure is applied to the outlet1688, a liquid composition can be moved into the port1632(or the liquid composition can be moved through a pre-filter to form a filtrate, either prior to or in the port1632), through the collection filter1684, and the aperture1682in the cover1609. As the liquid composition (or filtrate) passes through the collection filter1684, the analyte(s) of interest can be trapped in the collection filter1684, and the portions of the liquid composition (or filtrate) that are not trapped by the collection filter1684can pass through the collection filter184, and optionally to waste or another receptacle. The collection filter1684can be sized, charged and/or functionalized to collect the analyte(s) of interest.

As mentioned above, the sample collection system1657shown inFIG. 26is similar to that of the sample collection system1357ofFIGS. 21 and 22; however, it should be understood that any of the sample collection systems857,957,1057,1157,1257,1357,1457and1557described above can be used in the sample preparation and collection system1607instead.

In use, a liquid composition can be positioned in the reservoir1620of the container1602. In some embodiments, the sample preparation and collection system1607, or a portion thereof, can be oriented in a first orientation in which the liquid composition is directed toward the agitation system1680for agitation (e.g., oriented so that the agitation system1680is at the bottom of the sample preparation and collection system1607). After the liquid composition has been agitated, the sample preparation and collection system1607, or a portion thereof, can be oriented in a second orientation (e.g., inverted) in which the liquid composition is directed toward the sample collection system1657for capture of one or more analytes of interest (e.g., oriented so that the sample collection system1657is at the bottom of the sample preparation and collection system1607). Said another way, the liquid composition can be moved in the fluid path1692to the agitation system1680for agitation without being exposed to ambience, and the liquid composition can then be moved in the fluid path1692to the sample collection system1657without being exposed to ambience.

The sample preparation and collection system1607ofFIG. 26is shown as not including a filter for pre-filtering the liquid composition prior to collection, or a liner, but it should be understood that such features can be employed in the sample preparation and collection system1607similar to how such features are employed in various embodiments described above. For example, in some embodiments, the agitation system1680can instead be formed in a base of a liner, and the sample collection system1657can be employed in the lid1606(e.g., such as the case for the sample collection system1357described above and illustrated inFIGS. 21 and 22). In such embodiments, the lid1606can be adapted to be coupled to the liner, and following use of the sample preparation and collection system1607, the lid1606, the liner, the agitation system1680and/or portions of the sample collection system1657that are not used in subsequent processing steps can be discarded.

In the embodiment illustrated inFIG. 26, the agitation system1680is coupled to the lid1606and the sample collection system1657is coupled to the base1627of the container1602. However, it should be understood that the agitation system1680can instead be coupled to the base1627of the container1602(or a base of a liner) and the sample collection system1657can be coupled to the lid1606. Furthermore, in some embodiments, the agitation system1680and the sample collection system1657can be coupled to the same end of the sample preparation and collection system1607. For example, in some embodiments, the agitation system1680can be coupled to the lid1606(or the container1602), as shown inFIG. 26, and the sample collection system1657can also be coupled to the lid1606(or the container1602). In such embodiments, the sample preparation and collection system1607can be oriented in one orientation for agitation and collection. Additionally, a liner can be employed in embodiments in which both the agitation system1680and the sample collection system1657are coupled to the lid1606.

In some embodiments, such as the embodiment illustrated inFIG. 26, the agitation system1680can be positioned in a portion of the sample preparation and collection system1607that is removable (e.g., the lid1606or a removable portion of the container1602), such that the agitation system1680is movable into and out of the fluid path1692and into and out of fluid communication with the reservoir1620and/or the liquid composition. However, in some embodiments, reduced risk of contamination can result when the liquid composition is not exposed to ambience throughout the processing steps (e.g., agitating, and/or pre-filtering, etc.) and the collecting step. However, in some embodiments, the sample preparation and collection system1607can be opened following collection in order to retrieve the sample collection system1657, or a portion thereof, for further processing.

In some embodiments, the sample preparation and collection system1607(e.g., the sample preparation system1600) can include a first lid1606, as shown inFIG. 26, and a second lid, for example, that can resemble the lid106shown inFIG. 2. In such embodiments, after the liquid composition has been agitated, the sample preparation and collection system1607can be inverted (e.g., the liquid composition can be moved away from the agitation system1680), the lid1606can be removed, and the second lid can be coupled to the container1602(and/or a liner). In some embodiments, the container1602includes a first removable portion (e.g., that includes the base1627) that includes the agitation system1680and a second removable portion that can be coupled to the remainder of the container1602after agitation and after removal of the first removable portion. Similarly, in some embodiments, the sample collection system1657can be coupled to a removable portion (e.g., a lid, base, etc.) of the sample preparation and collection system1607(e.g., the sample preparation system1600). While such replaceable components can be employed to accomplish the various processing and collection steps, embodiments that do not require opening of the fluid path1692can provide reduced risk of contamination.

Any of the sample collection systems857,957,1057,1157,1257,1357,1457,1557, and1657described above can include multiple pre-filtering and/or multiple collection filtering steps. For example, a liquid composition can be filtered to form a first filtrate. The first filtrate can then be filtered again to form a second filtrate. This could be accomplished, for example, using the filters234and234′ described above and illustrated inFIG. 4. The second filtrate can then be moved into a sample collection system, and through a first collection filter that includes a first functionality to collect a first analyte of interest. The portion of the second filtrate that passes through the first collection filter can then be passed through a second collection filter that includes a second functionality to collect a second analyte of interest. In this example, the first and second pre-filters and the first and second collection filters are positioned in series. However, one or both of the pre-filters and the collection filters can be used in parallel instead. For example, the second collection filter can be located in a fluid path at the same location as the first collection filter such that a liquid composition or a filtrate can pass through both collection filters at the same time. A variety of other configurations and numbers of pre-filters and collection filters can be conceived of, based on the embodiments described herein and illustrated in the accompanying drawings.

In addition, a sample collection system of the present disclosure (e.g., any of sample collection systems857,957,1057,1157,1257,1357,1457,1557, and1657described above) can be employed in a portion of a sample preparation system (e.g., any of the sample preparation systems100,200,300,400,500,600,700,800,900,1000,1100,1300,1500, and1600described above) that is movable between a first position in which the liquid composition is in fluid communication with the sample collection system and a second position in which the liquid composition is not in fluid communication with the sample collection system. For example, in some embodiments, the sample collection system can be employed in a lid (e.g., any of the lids106,206,306,406,506,606,706,806,906,1106,1306,1506, and1606described above) that is movable between a first position with respect to a container (e.g., any of the containers102,202,402,502,1102,1502, and1602described above) and/or a liner (e.g., any of the liners104,404,504,604,1104,1504) in which the sample collection system is positioned to collected any analyte(s) of interest from the liquid composition, and a second position with respect to the container and/or the liner in which the sample collection system is positioned to elute any collected analyte(s) of interest out of the sample preparation system. By way of example only, the sample collection system can be employed in a lid of a sample preparation system, and the lid can be rotatable between a first position and a second position with respect to the container and/or the liner.

Furthermore, any of the above sample collection systems857,957,1057,1157,1257,1357,1457,1557, and1657can include more than one type of capture or collection, e.g., nonspecific and specific capture can both be utilized in one sample collection system.

Any of the sample preparation and collection systems807,907,1007,1107,1207,1307,1407,1507, and1607comprising any of the sample preparation systems100,200,300,400,500,600,700,800,900,1000,1100,1300,1500, and1600and any of the sample collection systems857,957,1057,1157,1257,1357,1457,1557, and1657described herein, and portions and combinations thereof, can be used together to prepare and collect samples by generally following the sample preparation and collection method10described above and illustrated inFIG. 1. One of ordinary skill in the art will also understand that various components from one sample preparation system described herein can be used in combination with other components from another sample preparation system described herein, without departing from the spirit and scope of the present disclosure. For example, the receptacle604can be used in place of the liner1104in the sample preparation system1100. Similarly, various components from one sample preparation and collection system can be used in combination with other components from another sample preparation and collection system, and various components from one sample collection system can be used in combination with other components from another sample collection system. For example, any of the above-described sample collection systems can be coupled to a lid of a sample preparation system and/or to a base of the sample preparation system.

An exemplary method will now be described in detail using the sample preparation system600ofFIGS. 9-12, the sample collection system1057ofFIG. 16, and the sample collection system1357ofFIGS. 21-22. In the following example, however, the sample collection system1057will be assumed to be coupled to the base626of the receptacle604, rather than to the cover609. The base626of the receptacle604will be assumed to be removable and replaceable (e.g., by a base626that does not include the sample collection system1057), if necessary.

A source can be positioned within the filter634, the filter634can be coupled to the lid606(which is coupled to the receptacle604), and a diluent can be poured through the filter634to form a liquid composition in the reservoir622comprising the source and the diluent. Nutrients for one or more bacteria of interest can be coated or adsorbed onto an inner surface of the receptacle604, and can become hydrated when the diluent is added to the reservoir622.

The liquid composition can be agitated to mix the source and the diluent (including the rehydrated nutrients) and to dissolve, disperse, suspend and/or emulsify the source in the diluent. Agitation may include any of the above-described processes, and for example, can be linear, in a circular orbit, an elliptical orbit, a random orbit, a combination thereof, or of other means to ensure effective and efficient mixing of the source and the diluent. The sample preparation system600may be further secured by clamping or other means during agitation to minimize spillage and/or loss of the liquid composition.

In some embodiments, the liquid composition can be agitated by coupling the sample preparation system600to a Burell Model 75 Wrist Action Shaker (Burrell Scientific, Pittsburgh, Pa.), and agitating the sample preparation system600at a frequency of 10 to 2000 cycles/minute, and in some embodiments, at a frequency of 200 to 500 cycles/minute for a selected duration of time. In some embodiments, the sample preparation system600can be mounted at a distance from the shaker arm from between 5 cm and 50 cm, and in some embodiments, between 10 cm and 20 cm. In some embodiments, the sample preparation system600can inscribe an arc of 5 degrees to 30 degrees, and in some embodiments, between 15 degrees and 20 degrees. The liquid composition may be agitated for at least 10 seconds, in some embodiments, at least 15 seconds, in some embodiments, at least 30 seconds, in some embodiments, at least 40 seconds, and in some embodiments, at least 60 seconds. In some embodiments, the liquid composition can be agitated for at most 15 minutes, in some embodiments, at most 10 minutes, in some embodiments, at most 5 minutes, and in some embodiments, at most 3 minutes.

In some embodiments, the liquid composition can be vortexed in a VX-2500 Multi-Tube Vortexer (VWR Scientific Products, West Chester, Pa.) at an agitation frequency of 200 to 5000 rpm, and in some embodiments, of 1000 to 3000 rpm for a selected duration of time. The vortex orbit can be linear, circular, elliptical, random, or a combination thereof. In some embodiments, the orbit is between 0.25 cm and 5 cm, and in some embodiments, between 1 cm and 3 cm.

A plurality of sample preparation systems can be agitated simultaneously, by being placed on a plate, an arm or other device, and secured by gravity, clamping or other means for subsequent agitation. For example, in some embodiments, one to about fifty sample preparation systems are agitated simultaneously, and in some embodiments, about 10 to about 25 sample preparation systems are agitated simultaneously on a single agitation device or with multiple agitation devices.

In some embodiments, the liquid composition can be agitated by the addition of a mechanical stirrer having a shaft and stirring blades, which may be inserted through any of the possible apertures described above that are not occupied. In some embodiments, the liquid composition can be agitated by employing a lid (e.g., lid1106) or a base (e.g., base1127of container1102) that includes means for agitating (e.g., blending blades); coupling such a lid or base to the container (e.g., container1102) and/or liner (e.g., liner1104, if employed); orienting the sample preparation and collection system (e.g.,1107) toward the means for agitating; and operating the means for agitating. In some embodiments, agitation of the liquid composition can be accomplished with steel ball bearings, magnetic stirring bars, blades, and other means to assist in breaking up and/or dispersing the source in the diluent to release any analyte(s) of interest from the source. The agitation methods described above are included by way of example only and are not intended to be limiting. One of ordinary skill in the art will understand that other similar agitation methods can be employed.

The filter634can act as a pre-filter (and need not include the lower portion635bof the frame635) to catch relatively large insoluble matter and to filter the liquid composition to form a filtrate that is positioned in the reservoir622below the filter634. The filtrate can then be allowed to interact with the sample collection system1057, and particularly, with the antibodies1094that are immobilized at the base626of the receptacle604. In some embodiments, the antibodies1094can be immobilized on a removable strip that is coupled to an inner surface of the base626of the receptacle604, and the removable strip, after being allowed to interact with the antibodies1094, can be removed and transferred to another device for subsequent processing.

After the filtrate has been formed in the reservoir622of the receptacle604, the cover609can be coupled to the lid606to close the sample preparation system600and to allow the filtrate to interact with the antibodies1094. The sample preparation system600can be transferred to an incubation environment to further enrich the filtrate. Prior to or after incubation, the filter assembly633can be removed from the reservoir622; however, the filter assembly633need not be removed.

In some embodiments, after the bacteria of interest have been captured by the antibodies1094, the bacteria can be further processed. For example, the filter assembly633and any uncaptured filtrate can be removed from the reservoir622of the receptacle604, such that all that remains in the reservoir622are the captured bacteria of interest (alternatively, the base626or a removable strip in the base626can be removed and positioned in a new sample preparation system600). A lysing agent and, optionally, an elution solution (e.g., a second diluent comprising one or more of these items) can then be added to the reservoir622to lyse the bacteria that have been captured by the antibodies1094, and, optionally, to elute the bacteria from the antibodies1094.

Then, the sample collection system1357comprising the collection filter1384can be coupled between the lid606and the cover609(alternatively, a new lid606/1306and cover609/1309can be coupled to the receptacle604). The collection filter1384can be functionalized to capture specific nucleic acid sequences from the bacteria of interest. The filter assembly633(and, likely a new filter assembly633) can be positioned in the reservoir622to filter any cellular debris resulting from the lysing process. A vacuum can be applied to the outlet1388of the sample collection system1357, the liquid composition comprising the second diluent and the lysed bacteria of interest can be forced through the filter634to form a filtrate, and the filtrate can be forced through the collection filter1384to collect the nucleic acids of interest from the bacteria of interest. As described above, positive pressure can be applied to the receptacle604to move the liquid composition through the filter634and the collection filter1384, rather than negative pressure, using any of the above-described techniques.

The cover609can then be decoupled from the sample preparation system600, and the collection filter1384with the captured nucleic acids of interest can be removed and transferred to another device or location for subsequent processing.

The above detailed example is included by way of example only and is not intended to be limiting. Based on the above descriptions of the sample preparation and collection method10, and the various embodiments of the sample preparation and collection system of the present disclosure, one of skill in the art should understand the various ways in which the sample preparation and collection system of the present disclosure can be used to prepare and collect samples.