Patent Abstract:
A liquid testing assembly for testing a liquid, the assembly comprising a test vessel and a stopper adapted to fit into a free end of the vessel. The stopper substantially hermetically seals the test vessel from the ambient. Further, the assembly includes a support coated with one or more identifying materials for identifying one or more constituents of the liquid. The support is fixed in the stopper and/or the vessel and extends into its interior for a predetermined distance. The liquid testing assembly when assembled is pre-evacuated to a predetermined vacuum sufficient to draw a predetermined volume of liquid to be sampled into the test vessel. The predetermined volume is of such an amount that it wets the one or more identifying materials ensuring identification of one or more constituents present in the liquid. A kit employing the liquid testing assembly is also discussed.

Full Description:
CROSS REFERENCE TO RELATED APPLICATION 
       [0001]    The present application claims priority rights from U.S. Provisional Application 60/881,846 filed Jan. 23, 2007 and U.S. Provisional Application 60/960,634 filed Oct. 9, 2007. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to a liquid testing assembly for use in identifying constituents of liquids. 
       BACKGROUND OF THE INVENTION 
       [0003]    Culturing microorganisms found in bodily fluids, including urine, to determine an illness is known in the art. Originally, such culturing was carried out in laboratories by collecting urine from a patient in a collection container, dipping a transfer utensil into the urine in the cup, streaking a culture medium in a Petri dish with the dipped transfer utensil, and then incubating the dish for a predetermined amount of time. After incubation, microbial colonies appeared on the medium and qualitative and quantitative results were determined. 
         [0004]    Currently, dipslides are used for culturing urine samples in laboratory and non-laboratory settings, the latter including doctors&#39; offices or medical clinics. Dipslides are culture (growth) medium coated, generally paddle-like, supports which are dipped directly into the urine collected in a collection container. Typically the paddle is coated with a different culture medium on each of its two sides; it comes with a container and stopper into which it fits during incubation after it has been dipped into the urine. The dipslides are typically incubated at the sample collection site, typically at about body temperature 37° C. Culturing generally requires that the stopper not be tightly sealed so that air can enter allowing for the growth of aerobic microorganisms. After initial incubation at the sample collection site, the dipslides are sent to a clinical laboratory for further incubation. If the results of culturing are negative, nothing further is done. If the results are positive, the dipslide is touched by a transfer utensil which in turn is used to streak agar in a Petri dish. The dish is then incubated at the laboratory, and, after a sufficient incubation period, examined to verify the previous positive results. 
         [0005]    Dipslides are produced by many producers such as Oxoid Ltd., Basingstoke UK and Accepta Ltd., Manchester, UK. Several variants of dipslides are available, such as the Diaslide™ and Dipstreak™ produced by NovaMed Ltd. of Jerusalem Israel. These operate essentially in the same way as the simpler dipslides but with slight variations. In all cases, a urine collection container containing urine must be opened and the culture (growth) medium coated paddle must be dipped directly into the open container. After withdrawing the paddle, it is placed in a test tube and incubation is begun on-site. The whole process is performed by personnel not necessarily trained in handling potentially bio-hazardous materials, such as may be present in the urine. 
         [0006]    Urinalysis today is done in a manner very similar to microbial culturing of urine discussed above. Urine is collected from the patient in a sample collection vessel. A test strip impregnated or coated with one or more reagents that react with one or more components often found in urine is dipped into the collection vessel. Changes in the reagent coated strip are then noted either visually or instrumentally. Typical urine test strips for use in urinalysis are manufactured by Roche Diagnostics, Basel, Switzerland, Bayer Corporation, Tarrytown, N.Y., (Multistix®) and Dialab GmbH, Vienna, Austria. Typical instrumental analyzers for reading dipped urine test strips are manufactured, for example, by Greiner Bio-One GmbH, Kremsmunster, Austria and Roche Diagnostics, Basel, Switzerland. 
         [0007]    The problems with this type of urinalysis are similar to those encountered when culturing uropathogens as described above. A collection cup containing a potentially bio-hazardous liquid, urine, must be opened and a urine test strip must be dipped by a member of the medical staff or a laboratory technician into the liquid. In the case of urinalysis, instruments used for reading the urine test strip must be cleaned often since there is direct contact between the dipped test strip and the electronic reader and other parts of the instrument. When visually reading a urine test strip, the strip is compared to a chart provided by the manufacturer typically positioned on the bottle in which the strips are sold. Often, when comparing the color of the strips to the colors on the chart, the strip is brought near to the chart actually touching it. This allows for the spread of pathogenic organisms. 
         [0008]    In view of the above, it would be advantageous to develop a closed system for microbial culturing and/or analysis of bodily fluids which reduces the dangers of contamination. Additionally, it would be advantageous to develop a closed system, which persons not necessarily trained in microbiological procedures could use without increasing the attendant health risks to them. There is also a need for a product that would allow dipslides to be sent for further testing in laboratory settings without escape of the liquid from the container and without it rewetting the medium coated paddle. It would also be advantageous to develop a system that is disposable and low cost. 
       SUMMARY OF THE PRESENT INVENTION 
       [0009]    It is an object of the present invention to provide a liquid test assembly which reduces sample contamination while also reducing potential health hazards to health care workers. 
         [0010]    It is an object of the present invention to provide a liquid testing assembly which does not expose a urine sample to the ambient when the sample is transferred from a collection container to a urine test strip assembly used for urinalysis or to a microbial culturing liquid testing assembly (dipslide) used for uropathogen culturing. 
         [0011]    It is a further object of the present invention to provide a low cost liquid testing assembly for use in microbial culturing which requires less attention and training on the part of the personnel carrying out the culturing procedures. 
         [0012]    It is a further object of the invention to provide an assembly for liquid testing usable at the site of sample collection and not necessarily in a laboratory setting. 
         [0013]    It is yet another object of the present invention to provide a liquid testing assembly kit which includes a liquid testing assembly together with a sample collection container and a means for transferring the sample liquid from the collection container to the test vessel of the liquid testing assembly. 
         [0014]    It is a further object of the present invention to provide a liquid testing assembly wherein the results of testing can be measured by an instrumental reader without removing the identifying material coated support of the assembly from its test vessel. 
         [0015]    While what is discussed herein is described in terms of microbial culturing or chemical identification of urine samples, the liquid testing assemblies taught herein can be used for testing constituents of other bodily fluids or even liquids in other environments. If appropriately modified with the proper identifying materials, the assemblies can be used to identify constituents of other bodily fluids, such as blood or saliva. These constituents inter cilia may include drugs, alcohol, and pregnancy markers. Similarly, the identifying materials can be modified to be used in industrial environments, such as food processing or waste management. Also similarly, the assemblies of the present invention may be used for testing biological fluids of species other than humans. 
         [0016]    In one aspect of the present invention there is provided a liquid testing assembly for testing a liquid. The assembly comprises a test vessel having a free end and a closed end and a stopper having first and second ends and adapted to fit into a free end of the test vessel. The first end faces into the interior of the test vessel, and substantially hermetically seals the interior of the test vessel from the ambient. The assembly also includes a support coated with one or more identifying materials for identifying one or more constituents of the liquid. The support is fixed to one or more of the stopper and the test vessel and extends into the interior of the test vessel by a predetermined distance when the stopper is positioned in the free end of the vessel. The liquid testing assembly when assembled is pre-evacuated to a predetermined vacuum sufficient to draw a predetermined volume of a liquid to be sampled into the test vessel from a liquid collection container. The predetermined volume is of such an amount that it wets the one or more identifying materials to ensure identification of one or more predetermined constituents present in the liquid. 
         [0017]    In one embodiment of the assembly of the present invention, the liquid testing assembly also includes one or more liquid traps positioned proximate to the closed end of the test vessel and distal from its free end. The liquid trap is configured, sized and operative to prevent the liquid from flowing in the direction of the stopper. 
         [0018]    In another embodiment of the assembly of the present invention, the one or more identifying materials is one or more culture media for culturing and determining the presence and nature of microbes present in the liquid. In some embodiments, the pre-evacuated test vessel includes a pre-selected gas composition artificially introduced into the test vessel to control the rate of microbial growth. In some embodiments, the trap is positioned at a distance from the stopper greater than the distance that the culture media coated support extends into the interior of the test vessel when the stopper is positioned in the free end of the test vessel. 
         [0019]    In a further embodiment of the assembly of the present invention, the one or more traps are at least two traps. In some cases, the two or more traps are each a different type of trap. 
         [0020]    In embodiments using traps, the traps are selected from one or more of the group of traps consisting of: conical plastic traps, floating plastic traps, liquid absorbing traps, and hydro-gel traps. In some cases, the liquid absorbing traps are formed of hydrophilic sponge foam. 
         [0021]    In a further embodiment of the assembly of the present invention, one of the one or more traps is a slow release trap and is positioned proximate to the free end of the test vessel and distal from the closed end of the test vessel. Liquid drawn from the liquid collection container forms a reservoir on a side of the slow release trap proximal to the stopper, the liquid slowly percolating from the reservoir through the slow release trap onto the assembly&#39;s support. 
         [0022]    In another embodiment of the assembly of the present invention, the test vessel is a test tube and the stopper is a tube stopper. 
         [0023]    In a further embodiment of the present invention, the one or more identifying materials are one or more chemical reagents for determining the presence of a chemical constituent of the liquid. In some embodiments, the identifying material is a plurality of chemical reagents positioned on a urine test strip. 
         [0024]    In a further embodiment of the assembly of the present invention, the test vessel includes a bar code identification label which contains patient identifying information. 
         [0025]    In yet another embodiment of the assembly of the present invention, the assembly further includes a means for distributing the drawn liquid. The means aids in the distribution of the drawn liquid as it passes over the identifying material coated support. 
         [0026]    In another embodiment of the assembly of the present invention, the support is affixed in the stopper so that it is eccentrically positioned at its point of attachment with relation to the center of the stopper. The support therefore does not interfere with the insertion of a cannula which transfers liquid from the collection container to the test vessel. 
         [0027]    In other embodiments of the assembly of the present invention, the test vessel further includes a permanently affixed identification tag. 
         [0028]    In still another embodiment of the assembly of the present invention, the one or more identifying materials are culture media and the support has a first side and a second side. The support is formed to include a divider having an aperture therein and further constructed so that the liquid flushes only the first side of the support. The assembly further includes: 1. one or more liquid traps which are fixedly attached to a side of the divider proximate to the one or more culture media; 2. one or more liquid traps positioned proximate to the closed end of the test vessel and distal from the free end, the one or more liquid traps configured, sized and operative to receive liquid and prevent the liquid from flowing in the direction of the stopper; and 3. one or more inoculating elements which after they are in contact with, and wetted by, the one or more liquid traps attached to the divider are operative to inoculate the one or more culture media coating the second side of the support. In some versions of this embodiment, the side of the support that includes the culture medium that is inoculated contains a track on which the one or more inoculating elements travel when inoculation is effected. In other versions of this embodiment, the support is coated with one or more culture media only on the second side of the support. In such cases, the side of the support that lacks a culture medium is constructed as a channel to bring the liquid to the one or more traps positioned proximate to the closed end of the test vessel. 
         [0029]    In another aspect of the present invention there is provided a disposable liquid testing kit. The kit comprises a liquid testing assembly for testing a liquid. The assembly comprises a test vessel having a free end and a closed end and a stopper having first and second ends and adapted to fit into the free end of the test vessel such that the first end faces into the interior of the test vessel. The stopper substantially hermetically seals the interior of the test vessel from the ambient. The assembly also includes a support coated with one or more identifying materials for identifying one or more constituents of the liquid. The support is fixed to one or more of the stopper and the test vessel. The support extends into the interior of the test vessel by a predetermined distance when the stopper is positioned in the free end of the test vessel. The kit also includes a liquid collection container for collecting a liquid and a cannula having one or more sharpened ends for piercing the stopper and transferring liquid from the container to the test vessel of the assembly. The liquid testing assembly of the kit when assembled is sterilized and pre-evacuated to a predetermined vacuum sufficient to draw a predetermined volume of a liquid to be sampled into the test vessel from the liquid collection container via the cannula. The predetermined volume is of such an amount so that it wets the one or more identifying materials to ensure identification thereby of one or more predetermined constituents present in the liquid. 
         [0030]    In yet another aspect of the present invention there is presented a liquid testing system. The system comprises a liquid testing assembly defined as above and a reader for measuring and analyzing the results of a test done on a liquid by the assembly. The reader reads and analyzes the test results by optical measurement of the identifying material coated support; while the support is positioned in the test vessel. The reader comprises one or more spectroscopic detectors and a bar code reader for detecting electromagnetic radiation. The reader further includes a test vessel holder where the holder is configured to receive one or more test vessels and the holder is positioned to allow the spectroscopic detector and bar code reader to measure electromagnetic radiation. The reader also includes a microprocessor in electronic communication with the one or more spectroscopic detectors and the bar code reader to analyze the detected radiation. The microprocessor is also in electronic communication with one or more output means operative to present the test results and patient identifying data. 
         [0031]    In an embodiment of the liquid testing system of the present invention the output means is selected from one or more of the following group of output means: a display, a printer, a patient file and a communications network. 
         [0032]    In another embodiment of the liquid testing system, the test vessel holder is configured to hold a plurality of test vessels when reading and analyzing test results. The test vessel holder is rotatable bringing each test vessel into position for reading and analyzing by the one or more spectroscopic detectors and the bar code reader. 
         [0033]    In yet another embodiment of the liquid testing system, the reader is a digital reader. 
       Definitions and Terminology Usage 
       [0034]    Proximal—The direction closest to the stopper of the test vessel, the vessel typically, but without being limiting, being a test tube. 
         [0035]    Distal—The direction furthest from the stopper of the test vessel, the vessel typically, but without being limiting, being a test tube. 
         [0036]    Top—The direction or end of the test vessel that is closest to its stopper. 
         [0037]    Bottom—The direction or end of the test vessel that is furthest from the stopper. 
         [0038]    Constituent of a liquid—As used herein, the term can refer either to a chemical constituent or to a microbial constituent or to both as the context of the discussion requires. 
         [0039]    Culture media—Media, and not medium, will generally be used herein. Typically, there is a plurality of such growth substances coating the liquid testing assembly supports discussed. This, however, is not to be understood as precluding the use of a single microbial growth substance should the user desire to use a single such substance. 
         [0040]    Liquid testing assembly—The present invention contemplates two closely related assemblies, a microbial culturing liquid testing assembly and a chemical analysis liquid testing assembly. The former is for qualitative and semi-quantitative detection of microbes in a liquid while the latter is for qualitative and semi-quantitative detection of chemical species in a liquid. When not specifically indicated, the term liquid testing assembly applies to both types of assemblies. In view of the fact that urine testing is usually being discussed, urine strip liquid testing assembly is often used instead of chemical analysis liquid testing assembly. 
         [0041]    Identifying material—The term refers either to a reagent to react with a chemical in the liquid being tested or to a culture medium for growing microbes in the liquid being tested. Whether a chemical reagent(s) or growth medium (media) is being referred to will be obvious from the context of the discussions. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0042]    The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in greater detail than is necessary for a fundamental understanding of the invention. The description taken with the drawings make apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
           [0043]    In the drawings: 
           [0044]      FIGS. 1A-1C  are schematic side views of a liquid testing assembly constructed according to various embodiments of the present invention, the assembly shown herein including a collecting trap; 
           [0045]      FIGS. 1D and 1E  are schematic side views of the liquid testing assembly constructed according to the embodiments in  FIGS. 1A-1C  drawing off a liquid from a collection container; 
           [0046]      FIGS. 2A and 2B  are schematic side views of the liquid testing assembly constructed according to a first embodiment of the present invention using a slow release trap and a top view of the slow release trap, respectively; 
           [0047]      FIGS. 2C and 2D  are schematic side views of the slow release trap constructed according to the embodiment of the present invention shown in  FIGS. 2A and 2B ; 
           [0048]      FIGS. 2E and 2F  are two schematic views of the slow release trap constructed according to an embodiment of the present invention shown in  FIGS. 2A and 2B ; 
           [0049]      FIG. 3  is a schematic side view of a liquid testing assembly constructed according to a second embodiment of the present invention, an embodiment without using the slow release trap; 
           [0050]      FIG. 4  is a schematic side view of a liquid testing assembly constructed according to a third embodiment of the present invention, the embodiment employing a double collecting trap; 
           [0051]      FIG. 5  is a schematic side view of a liquid testing assembly constructed according to a fourth embodiment of the present invention, the embodiment also including a hydrophilic foam trap; 
           [0052]      FIGS. 6A and 6B  are schematic side views of a liquid testing assembly constructed according to fifth and sixth embodiments of the present invention; 
           [0053]      FIG. 7  is a schematic side view of a liquid testing assembly constructed according to a seventh embodiment of the present invention; 
           [0054]      FIGS. 8A and 8B  are schematic side views of a liquid testing assembly constructed according to an eighth embodiment of the present invention and a stand for its use, respectively; 
           [0055]      FIGS. 9A and 9B  are schematic side views of a liquid testing assembly constructed according to a ninth embodiment of the present invention; 
           [0056]      FIGS. 10A and 10B  are schematic front and side views of liquid testing assemblies constructed according to a tenth embodiment of the present invention; 
           [0057]      FIGS. 10C-10H  are schematic views of elements in the liquid testing assemblies constructed according to the embodiment shown in  FIGS. 10A-10B ; 
           [0058]      FIGS. 11A-11E  are schematic front and side views of a liquid testing assembly constructed according to an eleventh embodiment of the present invention; 
           [0059]      FIG. 11F  shows another version of the liquid testing assembly constructed according to the embodiment of the invention in  FIGS. 11A-11E ; 
           [0060]      FIGS. 12A-12B  are schematic front and side views, respectively, of an embodiment of a liquid testing assembly of the present invention wherein the identifying materials are contained on a urine test strip; 
           [0061]      FIGS. 12C-12D  are two additional schematic views of the urine test strip support used in the embodiment of  FIGS. 12A and 12B ; 
           [0062]      FIGS. 12E-12F  are schematic front and side views, respectively, of a second embodiment of a liquid testing assembly of the present invention wherein the identifying materials are contained on a urine test strip; 
           [0063]      FIGS. 12G-12H  are two additional schematic views of the urine test strip support used in the embodiment of  FIGS. 12E and 12F ; 
           [0064]      FIGS. 13A-13C  are three schematic views of a third embodiment of a liquid testing assembly of the present invention using urine test strips as the source of the identifying materials; 
           [0065]      FIGS. 14A and 14B  schematically show an analyzer reader which can be used with the urine strip and culture media embodiments of the present invention; and 
           [0066]      FIG. 14C  shows a schematic block overview of the analyzer shown in  FIGS. 14A and 14B . 
       
    
    
       [0067]    Similar elements in the Figures are numbered with similar reference numerals. 
       DESCRIPTION OF PREFERRED EMBODIMENTS 
       [0068]    The present invention provides a disposable closed sterile liquid testing assembly. Urine for testing is collected in a urine collection container and transferred to the liquid testing assembly for urine chemical testing or urine microbial culturing. The liquid testing assembly is comprised of a test vessel and a stopper/cap for substantially hermetically sealing the test vessel which has been pre-evacuated to a pre-selected vacuum. A support coated with one or more identifying materials is affixed to either the stopper/cap or the walls of the test vessel or both. The transfer of the liquid is effected by the vacuum of the pre-evacuated test vessel without directly exposing the liquid to the ambient. 
         [0069]    Transfer is effected in a single step by using a needle cannula which pierces the stopper of the evacuated test vessel, typically an evacuated test tube, drawing a pre-selected volume of liquid from a urine collection container to the test vessel. Opening the closed collection container or liquid testing assembly is not required. Exposure to the ambient is obviated because the evacuated test vessel has fixed within it a urine strip or a culture (growth) media coated support, the latter also sometimes referred to herein as a dipslide. 
         [0070]    The transfer procedure described above obviates the need for opening the urine collection container. Additionally, it does not require medical personnel to dip a urine test strip or a culture media coated support directly into a urine sample. As a result, the exposure of health care personnel untrained in stringent microbiological procedures to possible bio-hazardous materials is reduced. The transfer procedure also reduces the chance of sample contamination providing false positive readings. 
         [0071]    The liquid testing assembly may also include one or more traps or other elements for preventing spillage of the liquid when the assemblies are handled or shipped. Furthermore, the one or more traps prevent rewetting of the dipslide or urine test strips after incubation has begun, regardless of the position of the liquid test assembly. 
         [0072]    The liquid testing assembly may also include means for distributing the vacuum drawn urine over the culture (growth) medium or over the urine test strip. These means include slow release traps. 
         [0073]    It is contemplated that the liquid testing assemblies of the present invention can be used for preliminary urinalysis or uropathogen culturing which can be carried out in a doctor&#39;s office or medical center. Initial microbial incubation at the site of urine collection is effected at 35-37° C. and then the culture is sent to a clinical laboratory for further incubation. The results can be determined visually or instrumentally at the laboratory. If the results of the microbial culturing are negative, the test tube is discarded. If the results are positive the stopper/cap of the liquid testing assembly is opened and a transfer tool, typically an inoculation loop, gathers material from the culture media coated support for streaking agar in a Petri dish. The dish is incubated and the results are again determined. Similarly, a positive result for the on-site urinalysis often requires that the urine sample in the urine collection container, or the urine sample in the liquid testing assembly, be sent to a laboratory for further analysis. 
         [0074]    As noted above, the stoppered test tube is prepared so that it is under a predetermined vacuum. The vulnerability of the liquid testing assembly to contamination is reduced since the test tube is opened only immediately before gathering a sample for streaking of an agar filled Petri dish with a transfer utensil, such as an inoculation loop. 
         [0075]    The present invention also teaches a kit including the above described liquid testing assembly, a urine collection container and a cannula for transferring a liquid from the collection container to the liquid testing assembly. The pre-determined, pre-calibrated vacuum in the substantially hermetically sealed test vessel allows for drawing off of a liquid sample from the sample collection container. The amount drawn off is approximately the smallest amount of sample required to sufficiently wet the culture media, or in the case of urinalysis, wet the reagent components coated, impregnated, or embedded in or on a urine strip. 
         [0076]    While what is described herein is described with regard to bacteriological or other microbial culturing of urine samples, typically carried out to diagnosis urinary tract infections (UTIs), it should be evident to one skilled in the art that the assembly and kit of the present invention may be used with other bodily fluids such as blood and saliva. Constituents such as drugs and alcohol, in addition to bacteria or other microbes, can be detected in these bodily fluids. It should also be understood that the assembly of the present invention may be used with liquids other than bodily liquids. Wherever the culturing of microorganisms is required, such as with liquid food stuffs, water supply systems or liquid waste deposits, the assembly of the present invention may be used. Before explaining at least one embodiment of the invention 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 the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
         [0077]    It is to be appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. 
         [0078]    Reference is now made to  FIGS. 1A-1C  which show schematic side views of a liquid testing assembly  10  which includes a urine culturing test tube  14  constructed according to any one of several embodiments of the present invention. In all of the Figures, test tube  14  is pre-evacuated to a pre-selected pressure. Test tube  14  may be made of any of many transparent plastics known in the art, such as polystyrene (PS) or polyethylene terephtalate (PET), or even of glass. 
         [0079]    Test tube  14  is covered by a stopper fitted to contain the vacuum for a pre-determined period, typically a period in excess of the shelf life of the culture media discussed below. Tube stopper  12  can typically be made of an elastomer such as moldable rubber, a soft polymeric resin, silicone or any other material that is flexible, liquid impermeable, and pierceable by a needle. The material should preferably be a material that may be self-sealing to liquids after being pierced. The exact shape of the stopper is easily producible by any of many techniques known in the art, such as, but without intending to be limiting, by injection molding. Vacutainers® manufactured by Becton Dickinson &amp; Co. of Franklin Lakes, N.J. may be used as a source of test tubes  14 . 
         [0080]    Test tube  14  contains a support  16  typically coated on both sides with a culture medium. Typically, the medium on each of the sides is a different medium. In some embodiments, the medium on each side of support  16  is the same. In other embodiments, the support may have more than two sides, often four sides, each covered with a different culture medium to encourage growth of different microorganisms. In yet other embodiments, each face of support  16  may be coated with more than one medium and the various media on the individual faces are separated by dividers. Many different culture media are known in the art and are commercially available. Therefore, these media will not be discussed herein. 
         [0081]    Liquid testing assembly  10 , here a microbial culturing assembly, also contains a trap  18  shown here as a conical trap, typically made of plastic. Trap  18  contains a small aperture, typically of the order of 2-3 mm in diameter, and is intended to trap excess liquid and prevent return of the trapped liquid to culture media coated support  16 . This is true regardless of the position of the test tube. Test tube  14  need only be standing vertically when the urine sample is dripping onto and percolating down culture media coated support  16 . After wetting the media, test tube  14  can be held in any position, for example horizontal, vertical or diagonal, because of trap  18 . 
         [0082]      FIGS. 1A and 1B  show two views of the same microbial culturing liquid test assembly  10  in which the culture media coatings on the two sides of the media support  16  are parallel to each other.  FIG. 1C  shows a schematic side view of an embodiment of microbial culturing liquid test assembly  10  where the two faces of support  16  coated with culture media are not parallel to each other. In  FIGS. 1A-1C  (and  FIGS. 1D-1E  discussed below) the connection of media support  16  to test tube  14  or stopper/cap  12  is not shown as these can be any of many different types. These connections, however, will be shown in all of the following Figures. There, it will become apparent that culture media coated support  16  may be supported and connected directly to stopper/cap  12  in any manner known to those skilled in the art. Alternatively, or additionally, support  16  may be attached to and/or supported by the walls of test tube  14 . 
         [0083]      FIGS. 1D and 1E  show the transfer of urine or other liquid from collection container  22  to microbial culturing liquid assembly  10 . The only difference between  FIG. 1D  and  FIG. 1E  is that the vacuum in the test tube of  FIG. 1D  allows for entry of a volume of urine only up to culture medium support  16  while in  FIG. 1E  the vacuum allows for entry of a volume of urine that reaches and covers part of culture medium support  16 . Cannula  24  is actually attached to, and part of, closed urine collection container  22  having top  21 . Cannula  24  can be used to pierce stopper  12  and transfer a predetermined volume of sample from collection container  22  to partially evacuated test tube  14 . Collection containers with cannula are known in the art and sold commercially, for example, by Becton Dickinson and Co. of Franklin Lakes, N.J. 
         [0084]    Test tube  14  with stopper  12  and with culture media coated support  16  attached therein is prepared so as to be under a pre-determined vacuum. The pre-determined vacuum is empirically determined and is intended to draw off a pre-determined volume of sample from urine sample collection container  22  through cannula  24 . 
         [0085]    The predetermined vacuum obviates the need for the technician to open the urine collection container  22  and to dip the identifying material coated support  16  into collected urine  28 . 
         [0086]    It is expected that a vacuum of 1-3 inches of Hg (approximately 25-76 Torr or about 0.033-0.100 bar) in a 10 ml tube will be sufficient to draw about 1 ml of sample into the pre-evacuated test tube  14  which forms part of liquid testing assembly  10 . This is expected to be sufficient to wet culture media coated support  16 . 
         [0087]    Becton-Dickenson&#39;s 10 ml Vacutainers® are typically produced so as to have a vacuum of about 18-20 inches Hg (about 500 Torr or about 0.66 bar) when about 9 ml of urine is to be drawn from a urine collection cup into a 10 ml test tube. Such volumes are far in excess of what is required for microbial culturing of urine samples with the liquid testing assemblies of the present invention. In the present cases, typically, approximately 0.7-1.5 ml of urine is required. This can be obtained with a vacuum of 2-5 inches of Hg, a vacuum the magnitude of which still leaves a significant amount of air in the test tube. 
         [0088]    Liquid testing assembly  10  ( FIGS. 1A-1C ), with their pre-calibrated vacuums, draw off sample liquid in a manner similar to that shown and discussed in U.S. Pat. No. 6,921,395 to Carano et al; U.S. Pat. No. 4,927,605 to Dorn et al; U.S. Pat. No. 4,116,066 to Mehl et al; and U.S. Pat. No. 4,300,404 to Mehl et al, all herein incorporated by reference in their entireties. In these patents, an evacuated test tube is mated with a sample collection vessel. Sample liquid moves under vacuum from the collection vessel to the test tube via a needle cannula which pierces a stopper of the test tube. The covered sample collection container typically possesses a recess in its cover which contains the cannula used in the liquid transfer. The recess functions as a female structure to receive the evacuated test tube, the male structure, during sample transfer. 
         [0089]    In some embodiments, the pre-vacuum includes other gases that are artificially introduced to accelerate or decelerate microbial growth on culture media coated support  16 . These gases could be oxygen, nitrogen, etc. as the case dictates. This results in a gas mixture with component percentages different from ambient atmospheric percentages. 
         [0090]    It should be noted that when microbial culturing is being effected using the liquid testing assemblies of the present invention, the stopper or cap must be partially opened. This enables aerobic or aerophilic microbes to be cultured. 
         [0091]    It should be noted that the liquid testing assemblies of the present invention allow for gentle shaking of the assemblies to ensure full wetting of the growth medium by the liquid. 
         [0092]    Because culture media coated support  16  is not exposed to the air until, and if, the initial testing is positive, air borne microorganisms only minimally, if at all, contaminate the specimens. If the test is positive, as noted above, a transfer utensil, typically an inoculation loop, is used to gather material from support  16  to streak a culture medium filled Petri dish. The dish is then incubated entirely in a clinical laboratory. Additionally, because the fluid is pulled off by vacuum directly from a closed sample collection vessel to a closed test tube, the risk of infection to the health care personnel is reduced. 
         [0093]    In  FIG. 2A , to which reference is now made, there is presented another embodiment of the present invention. Since the embodiment is similar in structure and operation to the microbial culturing liquid testing assembly  10  shown in the embodiments of  FIGS. 1A-1E , only novel features of the structure in  FIG. 2A  will be discussed. Connectors  15  join culture media coated support  16  to stopper (or cap)  12  by being fixed or implanted in the latter. Alternatively, culture media coated support  16  could be connected to the side walls of test tube  14 . There is a slow release trap  30  positioned near stopper (or cap)  12 . 
         [0094]    Reference is now made to  FIG. 2B  where a top schematic view of a slow release trap is shown. Trap  30  contains slots  32  which allow for slow entry of urine transferred from a collection container as shown in  FIGS. 1D and 1E  into the body of test tube  14 . Slow release trap  30  allows for better wetting of culture media coated support  16 . 
         [0095]      FIGS. 2C and 2D  and  FIGS. 2E and 2F  show additional views of two versions of slow release trap  30  and its slots  32 . Liquid held in reservoir  34  percolates through slots  32  over culture media coated support  16 . Cannula  24  is shown in  FIG. 2D  and is similar to cannula  24  shown and discussed in conjunction with  FIGS. 1D and 1E . 
         [0096]      FIG. 3  is a view of the same embodiment as  FIG. 2A  but without the slow release trap  30 . 
         [0097]      FIG. 4 , to which reference is now made, shows a third embodiment of the present invention, one very similar to the embodiment shown in  FIG. 2A . Structural features which are the same as in previous Figures are labeled with the same numbers and are not discussed again. The novel feature in this third embodiment is the double lower conical trap  18 . Both conical traps  18  are constructed and operative as discussed above in conjunction with  FIGS. 1A-1C . 
         [0098]    Reference is now made to  FIG. 5  where a fourth embodiment of the present invention is shown, one similar to the embodiment shown in  FIG. 2A . The novel feature here is an expanding medical grade hydrophilic cellular foam  40  positioned at the bottom of test tube  14 . The foam expands when absorbing liquids and prevents the flow of liquid toward the top of test tube  14 . The foam acts as a second liquid trap at the bottom of test tube  14 . 
         [0099]    In yet another embodiment, a trap made from a hydro-gel material can be used instead of a foam trap. 
         [0100]    In turning to  FIG. 6A , a fifth embodiment of the present invention is shown. It is very similar to the one shown in  FIG. 2A  and is similarly numbered. The additional feature here is a floating disc  42 , typically made from an elastomeric rubber, silicone or plastic material that serves as an additional trap at the bottom of test tube  14 . It acts in conjunction with conical trap  18  to prevent the backward flow of urine by blocking the small aperture of conical trap  18 . 
         [0101]      FIG. 6B  shows a sixth embodiment of the present invention. There is a double conical trap  18 , each conical trap  18  being covered by a floating disc trap  42 . Typically, both the conical traps and the floating disc traps may be formed of light weight plastic. It can readily be understood by one skilled in the art that in some embodiments the two floating discs  42  by themselves can serve as the trap and the conical collection traps  18  need not be present. 
         [0102]    Reference is now made to  FIG. 7  where another embodiment of microbial culturing liquid testing assembly  10  is shown. The assembly is similar in construction and operation to the embodiment shown in  FIG. 5 . The additional feature here is a hydrogel or solution reservoir  44  which contains material that “captures” liquid not absorbed by foam  40 . 
         [0103]    In turning to  FIG. 8A , another embodiment of the invention very similar to the one shown in  FIG. 5  is illustrated. The additional feature here is a stand element  50  affixed permanently to the bottom of microbial culturing liquid testing assembly  10  allowing for better stability on a level surface. Stand element  50  is shown separately in  FIG. 8B . In other embodiments, stand element  50  may be a separate element into which test tube  14  may be inserted and then withdrawn as needed. 
         [0104]      FIGS. 9A-9B  show yet another embodiment of the present invention.  FIGS. 9A-9B  both show test tube  110  which is very similar to the test tubes of the embodiments shown in previous Figures, for example, in  FIG. 5 . Many of the elements shown in  FIGS. 9A-9B  have been discussed previously and will not be discussed again as their structure and operation is similar. These elements have been numbered as with similar elements in previous Figures but with the addition of an introductory digit “ 1 ”. 
         [0105]    The novel feature in this embodiment is a lateral opening and stopper  119 . This lateral opening allows for inserting an inoculating instrument for touching the culture medium on support  116  and then removing the instrument for streaking on a culture medium in a Petri dish. The difference between  FIGS. 9A and 9B  is the point and method of attaching culture media coated support  116  within test tube  114 . In both  FIGS. 9A and 9B , urine slowly passes attachment elements  117  and  111 , respectively, onto and along culture medium coated support  116 . The liquid then moves through aperture  113  in conical trap  118  and is absorbed by hydrophilic foam  140 . 
         [0106]    Reference is now made to  FIGS. 10A and 10B  which show front and side views, respectively, of yet another embodiment of the present invention. Many of the elements shown in  FIGS. 10A-10B  have been discussed previously and will not be discussed again as their structure and operation is similar. These elements have been numbered as with similar elements in previous Figures but with the addition of an introductory digit “ 2 ”. Microbial culturing liquid testing assembly  210  includes two conical traps  218  and a hydrophilic foam  240 . Culture medium coated support  216  is sloped for better dispersal of the liquid over culture media coated support  216 . There are also liquid dispersing elements  255  to assist in better dispersing the entering liquid over support  216 . Microbial culturing liquid testing assembly  210  has a tightly fitting cover  252  on its side. The embodiment also includes a slow release trap  230  through which the urine passes slowly when leaving reservoir  234 . 
         [0107]      FIG. 10D  shows the housing  260  of microbial culturing liquid testing assembly  210  shown in  FIGS. 10A and 10B . Housing  260  has an opening  268  in its bottom ( FIG. 10D ) into which bottom cover  262  ( FIG. 10E ) fits tightly. Housing  260  also has a lateral opening  266  on which cover  252  ( FIG. 10F ) fits.  FIG. 10H  shows the foam positioned at the closed end of testing assembly  210 . 
         [0108]    Insert  264 , shown in  FIG. 10C , is inserted through bottom opening  268  ( FIG. 10D ) of housing  260 .  FIG. 10C  shows that insert  264  may be, but without intending to be limiting, of a unitary construction. Insert  264  includes dispersing elements  255  for better dispersing the liquid over culture media coated support  216 . Insert  264  also includes double conical traps  218  including small apertures  213 . 
         [0109]    As noted above, the stopper (or cap)  212  of microbial culturing liquid testing assembly  210  must be kept partially open during incubation to allow culturing of the microbes. As a result, volatile substances can escape. In some embodiments, therefore, there is added at the bottom of the liquid testing assembly one or more materials that prevent the escape of volatile gases outside the test tube of the assembly when the test tube is opened. 
         [0110]    Reference is now made to  FIGS. 11A-11E  where front and side views of another embodiment of a microbial culturing liquid testing assembly of the present invention is shown. This embodiment is similar to the ones shown in  FIGS. 5 and 2A . Many of the elements shown in  FIGS. 11A-11E  have been discussed previously and will not be discussed again as their structure and operation is similar. These elements have been numbered as with similar elements in previous Figures but with the addition of an introductory digit “ 5 ”. 
         [0111]    Tube stopper  512 , constructed as described in conjunction with  FIGS. 1A-1C , essentially hermetically seals test tube  514 . A culture medium support  516  is coated with one agar culturing medium  590  on its first side and with a second agar culturing medium  592  on its second side. It should be understood that in some instances, media  590  and  592  may be identical. 
         [0112]    Support  516  is fixedly attached to tube stopper  512 . Support  516  is constructed and positioned so that when the liquid to be tested, typically, but without being limiting, urine, enters test tube  514 , the liquid descends to the bottom of test tube  514  via flushing channel  596  and not through inoculating channel  598  as discussed below. An arrow in  FIGS. 11A and 11E  indicates the direction of liquid flow. 
         [0113]    In all of  FIGS. 11A-11E  (and  FIG. 11F ), support  516  is formed to include a divider  582  which prevents liquid from directly entering inoculating channel  598 . Divider  582  includes an aperture  583  which facilitates the wetting of a hydrophilic cellular foam  541  by liquid which becomes trapped therein, as discussed further below, during the liquid transfer step best seen in  FIG. 11B . Foam  541  is attached to the side of divider  582  proximate to the agar coatings. While divider  582  is generally positioned transverse to the long axis of test tube  514 , divider  582 , in some instances, may be slightly sloped toward flushing channel  596 . 
         [0114]    An expanding medical grade hydrophilic cellular foam  540  is positioned at the bottom of test tube  514 . The foam expands when absorbing liquids and prevents the flow of liquid in the direction of stopper  512  should test tube  514  become inadvertently inverted. Foam  540  acts as a liquid trap at the bottom of test tube  514 . 
         [0115]    The liquid testing assembly of this embodiment also contains an inoculating element  594 , typically, but without being limiting, a bead-like element, that is in contact with foam  540  when test tube  514  is in its orientation as shown in FIGS.  11 A and  11 C- 11 E (and  FIG. 11F ). 
         [0116]    Inoculating element  594  may have many different shapes, for example spherical, cylindrical, and ellipsoidal. These shapes are exemplary only and are not intended to be limiting. Element  594  may be made from glass, substantially inert polymeric materials, or metals. These materials are also not intended to be limiting. 
         [0117]    In some variations of the embodiment in  FIGS. 11A-11E , there may be more than a single inoculating element  594 , that is, for example, more than a single bead or cylinder. Similarly, inoculating element  594  may be constructed so that it has finger-like projections with which to streak culturing medium  592 . 
         [0118]    Inoculating element  594  may move freely in the direction of stopper  512  as in  FIGS. 11A-11E ; alternatively, support element  516  may be constructed with a track (not shown) which guides inoculating element  594  as it moves towards stopper  512 . 
         [0119]    As can be seen in  FIG. 11B , divider  582  and attached foam  541  act as a stop for inoculating element  594  when it moves in the direction of stopper  512 . 
         [0120]    While hydrophilic foam traps  540  and  541  have been shown in  FIGS. 11A-11E  (and  FIG. 11F ), other types of traps such as those described hereinabove may also be used. 
         [0121]    Liquid may be brought to the liquid testing assembly using a collection container  522  and cannula  524  similar to the ones shown in  FIG. 1D , for example, and described in conjunction therewith.  FIG. 11B  shows this transfer of liquid  599  through cannula  524 ; the collection cup is not shown in the Figure. 
         [0122]    Inoculating element  594 , typically a rollable bead-like element, rolls from the foam  540  end of test tube  514  towards the stopper  512  end of test tube  514  when the assembly is inverted as in  FIG. 11B  from its usual orientation as in  FIG. 11A . It is wetted by foam  541 , which has been wetted during the liquid transfer phase as shown in  FIG. 11B , by some of the liquid  599  that has reached foam  541  via aperture  583 . When closed test tube  514  is returned to its original orientation wetted inoculating element  594  moves toward, and then rests on, foam  540 . During its return to foam  540 , inoculating element  594  intermittently streaks culture medium  592  generally at distances more or less equal to the circumference of the bead. These streaks are indicated by crosses  588  in  FIG. 11D . 
         [0123]    The liquid  599  that has wetted foam  541  does not descend via inoculating channel  598  towards foam  540 . When test tube  514  is inverted from its orientation in  FIG. 11B  back to its orientation shown in FIGS.  11 A and  11 C- 11 E (and  FIG. 11F ), liquid  599  enters flushing channel  596  and is absorbed by, and trapped in, foam  540 . 
         [0124]    Typically, but without being limiting, inoculating element  594  deposits less than about 25 microliters on agar culture medium  592  while medium  590  may typically be flushed by about 1-1.5 ml of fluid. 
         [0125]    In yet other variations of the embodiment shown in  FIGS. 11A-11E , and as shown in  FIG. 11F , there may be only one agar medium present, agar medium  592  (not visible) required for streaking. The second side of support  516  may be devoid of any culture medium  590 . 
         [0126]    Flushing of the assembly in  FIGS. 11A-11F  allows for the growth of a large microbial culture and a quick positive/negative determination. If the results obtained in the doctor&#39;s office or the medical center are positive, a more precise culturing is repeated in a professional clinical laboratory. 
         [0127]    When using the microbial culturing liquid testing assembly shown in  FIGS. 11A-11F , the inoculation process may begin in the doctor&#39;s office or in a medical center. Typically, the direct flushing of medium  590  is done with about 1-1.5 ml of liquid and medium  592  is inoculated with about 25 microliters of liquid. 
         [0128]    After a first period of incubation at 35-37° C. in the doctor&#39;s office or medical center, the microbial growth on medium  590  allows for a quick visual determination of whether the results are positive or negative. This can be done using commercially available colony density charts which show colony forming units per milliliter (CFU/ml). Typically, 70 to 80% of the samples are negative and there is no need to open the samples or send them on to a professional clinical laboratory for further testing. 
         [0129]    If the results of the sample in the doctor&#39;s office or medical center are positive, the sealed testing assembly is sent to a professional microbiological laboratory for final incubation and more precise testing. More precise colony counts are made using instrumental methods based on measurements of color and colony density. At the professional laboratory, additional testing is also done on medium  592 . This testing includes the steps of isolation, identification, detection and enumeration of microorganisms and pathogens. 
         [0130]    The worker at the professional laboratory may open the liquid testing assembly, remove the support with its media coatings and test for sensitivity to antibiotics of one or several microorganisms and/or perform dilution studies on these microorganism(s). For these tests, the lab worker may remove a tiny sample of the microorganism(s) on the media coated support and grow them in a controlled manner in a Petri dish. The support may then be returned to the test tube which is then recapped. 
         [0131]    In the following embodiments, a chemical analysis liquid testing assembly for testing chemical constituents of urine using urine test strips will be discussed. As with liquid testing assemblies employing culture media coated supports suitable for microbial culturing discussed above, the test tube used for urine strip liquid testing assemblies need not be opened during urine transfer and testing. Similarly, the cover of a urine collection container need not be opened. Urine can be transferred from the collection container to the test tube using the test tube&#39;s predetermined vacuum. As a result, health care personnel are spared exposure to possibly bio-hazardous urine constituents and the hazards of a wetted urine strip. As with the assembly containing a culture media coated support, the same collection container can be used to supply samples for additional urinalysis testing if the initial on-site reading of the wetted strip is positive. 
         [0132]    In chemical analysis liquid testing assemblies, more specifically, urine test strip liquid testing assemblies, the support can be a support to which a paper urine test strip has been affixed. In other embodiments, the paper of the urine strip is deemed to be the support and the chemical reagent or reagents are coated on or impregnated in the paper. The urine strip or the separate support to which the strip is affixed can be attached in any of many ways known in the art. Attachment may be effected to the stopper or to the walls of the test tube or to both the stopper and walls of the liquid testing assembly. If attached and supported by the walls, the urine strip should be spaced apart from the walls. 
         [0133]    Chemical analysis liquid testing assemblies can be designed to use the full range of traps described above in conjunction with microbial culturing liquid testing assemblies. These include slow release traps positioned proximal to the stopper of the assembly. 
         [0134]    Typically, the urine strip is fixed to, or implanted in, the stopper or walls of the test vessel eccentrically so as not to interfere with the needle cannula when it pierces the stopper during the liquid transfer process. The strip should be spaced apart from the wall of the test tube so as not to be continuously wetted by the urine because of capillary action and to prevent air or liquid bubbles from becoming entrapped between the strip and the walls of the test tube. A support element can be affixed to the strip inside the test tube to keep the strip spaced apart from, and essentially parallel to, the wall of the test tube. In general, the liquid should wet the strip and then fall to the bottom of the test tube. 
         [0135]    The volume of urine transferred to the test tube is governed by the pre-determined vacuum in the test tube. The volume of urine transferred via the needle cannula to the liquid testing assembly which contains the urine strip is less than the volume of the entire test tube. For a 10 cc test tube about 3 cc are drawn into the test tube. It is estimated that about three cc of liquid can be drawn off by a vacuum of about 4 inches of Hg. For a 3 cc test tube, about 0.7-1.2 cc of urine is needed. 
         [0136]    The height of the liquid in the test tube should typically extend to just above the bottom of the urine strip. 
         [0137]    As long as the urine strip is not immersed in liquid, the results of the urine test strip can be read visually while the strip remains in the test tube. The visual reading is typically compared against reagent color charts provided by the manufacturer of the strips. Visual readings can be made regardless of whether the test tube is in its vertical or its horizontal position. 
         [0138]    Excess liquid accumulates at the bottom of the test tube when the test tube is held vertically during and after the urine has wet the urine test strip. After being out of the urine for 60 seconds, the test strip can be visually read. It should be noted that the urine test strip can also be read when the test tube is held horizontally. When the test tube is lying horizontally and a reading is to be made, the liquid should lie between the strip and the wall of the test tube without actually touching the strip. 
         [0139]    In addition to visually reading the urine strip, the results of the test may be obtained by using an instrumental analyzer/reader. In both cases, the reading is made while the identifying material coated support is still inside the test vessel. Typically, the instrumental analyzer/reader, hereinafter “reader”, analyzes the strip optically. The reader typically will contain a receiving inlet into which the entire test tube, except for the stopper, is inserted. The reader reads the results through the transparent walls of the test tube, along the entire length of the test tube. 
         [0140]      FIGS. 12A and 12B , to which reference is now made, illustrate a urine strip liquid testing assembly constructed according to a first embodiment of the present invention.  FIGS. 12A and 12B  show front and side, respectively, schematic views of this first embodiment. 
         [0141]    Liquid testing assembly  310  includes a test tube  314  pre-evacuated to a pre-selected pressure. Test tube  314  is typically made of any one of many transparent plastics known in the art, such as polystyrene (PS) and polyethylene terephtalate (PET), or even of glass. Vacutainers® manufactured by Becton Dickinson &amp; Co. of Franklin Lakes, N.J. may be used as a source of test tubes  314 . 
         [0142]    Test tube  314  is covered by a stopper  312  fitted to contain the vacuum for a pre-determined period, typically a period in excess of the shelf life of the urine test strip. Tube stopper  312  can typically be made of an elastomer such as moldable rubber, a soft polymeric resin, silicone or any other material that is flexible, liquid impermeable, and pierceable by a needle, preferably a material that may be self-sealing to liquids after being pierced. The exact shape of the stopper is easily producible by any of many techniques known in the art, such as, but without intending to be limiting, by injection molding. 
         [0143]    Test tube  314  contains a support  316  to which is affixed a paper urine test strip, coated or impregnated with one or more chemical reagents, here a plurality of reagents. Each reagent is reactive and identifies a different possible constituent of urine, such as glucose, bilirubin, urobilirubin, ketones, nitrites or proteins. This list is typical and not intended to be limiting. Urine test strips suitable for the assemblies of the present invention may be obtained from many commercial sources, such as Roche Diagnostics, Basel, Switzerland, and Becton Dickinson, Franklin Lakes, N.J. 
         [0144]    Urine test strip assembly  310 , also contains a trap  318 , shown here as a conical trap, typically made of plastic. Trap  318  contains a small aperture typically on the order of 2-3 mm in diameter.  FIG. 12C , to which reference is now made, shows a schematic isometric view of an embodiment of a urine strip containing a plurality of chemical reagents  319  affixed to a test strip support  316 . The strip is somewhat recessed in support  316 . Traps, other than conical traps, such as those discussed above in conjunction with microbial culturing liquid testing assemblies can also be used in conjunction with urine strip liquid testing assemblies. This includes the slow release traps discussed above. 
         [0145]    In  FIGS. 12A-12B  support  316  is affixed to, or wedged against, the walls of test tube  314  using the ends  323  of support  316 . Other means of joining the test strip support  316  are possible and these should be evident to one skilled in the art. The method shown in  FIGS. 12A-12C  is not intended to be limiting. 
         [0146]      FIG. 12D  (and  FIG. 12C ) shows that reagents  319  on the reagent strip are positioned in a recess on support  316 . In  FIG. 12D , a passageway  332  is shown running from the top of test tube  314  to its bottom, allowing drawn off urine to percolate down past reagents  319 . Passage  332  is positioned between the wall of test tube  314  and support  316 . The liquid then falls on and passes through trap  318  and remains at the bottom of tube  314 . In order for the liquid to percolate down passageway  332  air must be displaced. Displaced air moves through apertures  325  in support ends  323  from the bottom of test tube  314  to its top. 
         [0147]    Transfer of urine or other liquid from a collection container to urine test strip assembly  310  as in  FIGS. 12A-12D  is effected using a system similar to the system shown in  FIGS. 1D and 1E  and the discussion in conjunction therewith and therefore will not be repeated here. 
         [0148]    Test tube  314  with stopper  312  and with urine strip support  316  affixed therein is prepared so as to be under a pre-selected vacuum. The pre-selected vacuum is empirically determined and is intended to draw off a pre-determined volume of sample from a urine sample collection container ( FIGS. 1D and 1E ) through a cannula  24  ( FIGS. 1D and 1E ). The pre-selected vacuum, and therefore the pre-selected sample volume to be drawn off, is intended to draw off a volume significantly less then the volume of tube  314 . 
         [0149]      FIGS. 12E-12H  show schematic views of another embodiment of the present invention.  FIGS. 12E-12H  map into  FIGS. 12A-12D  of the previous embodiments. The difference between the embodiments is that the plurality of chemical reagents  319  positioned on a urine strip affixed to strip support  316  of  FIGS. 12C and 12D  are recessed on support  316 ; in  FIGS. 12G and 12H  the chemical reagents  319  are coated or embedded on a urine test strip affixed to strip support  316  and project forward from support  316 . Again, there is a passageway  332  that runs the length of support  316  allowing the liquid to percolate past bottom support end  323  and down past trap  318 . As above, in order for the liquid to percolate down passageway  332  air must be displaced. Displaced air moves through apertures  325  in support ends  323  from the bottom of test tube  314  to its top. 
         [0150]    Reference is now made to the embodiments of  FIGS. 13A to 13C . The embodiment of the urine strip assembly shown in these Figures is very similar to that shown in  FIGS. 12A-12H . Similar elements are similarly numbered with the introductory digit of “ 3 ” being replaced by the introductory digit of “ 4 ”. 
         [0151]    The main difference between the embodiment in  FIGS. 13A-13C  and  12 A- 12 H is that there is a foam trap  440  below conical trap  418 . Conical trap  418  is similar in form and construction to the conical trap discussed previously in conjunction with  FIGS. 12A ,  12 B,  12 E and  12 F. As in previous embodiments, aperture  413  is formed in trap  418  and restricts liquid back flow. 
         [0152]    Shown on the test tube of  FIG. 13A  is a permanently affixed printed bar code  429  which serves as a sample identification tag. It should readily be understood that while a bar code has not been shown in previous embodiments of the liquid testing assemblies discussed herein, such a bar code can be a part of any of the test tubes used in previous embodiments. 
         [0153]    Reference is now made to  FIGS. 14A-14C .  FIGS. 14A and 14B  show embodiments of digital readers  800  that can be used to read and analyze the urine strips and/or culture media coated supports while both are still in the test tube of a liquid testing assembly constructed according to the embodiments of the present invention. Reader  800  discussed in conjunction with these Figures allows for a completely closed system after the point of urine collection from a patient into a collection cup. 
         [0154]    In  FIG. 14A , a test tube cassette  806  is shown which can rotate so that all the test tubes positioned in the plurality of tube receiving inlets  805  of cassette  806  can be brought opposite a spectroscopic detector and an optical bar code scanner (both not shown) for readings. The spectroscopic detector determines color changes in closed test tube  710  which contains a urine strip having a plurality of reagents coated or impregnated thereon. It also determines the color changes and microbial colony density on test tube  610  which contains a culture media coated support. The support has been incubated at the site of urine collection with the possibility of continued incubation at a clinical laboratory. Both test tubes  710  and  610  contain bar codes which contain patient related information and are read by the optical bar code scanner. 
         [0155]    The receiving inlet  805  may be formed so as to have a protrusion or a slot along its side. This protrusion or slot is complementary to and mateable with test tubes constructed to include a slot or protrusion, respectively, in the test tubes side. This feature allows for the test tubes inserted into the reader&#39;s (or analyzer&#39;s) receiving inlets to be positioned in one well-defined orientation with respect to the detector of the reader or analyzer. This reduces poor readings resulting from the urine strip or culture medium being improperly aligned against the digital detector. 
         [0156]    It should be evident to one skilled in the art that the sources of radiation and the detectors used in readers employed for urine test strip analysis may be, and typically are, different from the sources and detectors required to read color changes in culture media coated supports. Therefore, it should be evident that separate readers may be required for urine test strip analysis and analysis of culture media coated supports. 
         [0157]    Reader  800  includes an input means  804 , here a key pad, and an LCD display  802 . It also contains a printer which prints the results  808  of the reading and also the bar code information. Reader  800  is activated by on/off switch  878  and is connected to a power source by connection  870 . Reader  800  may also be in electronic communication with at least one of the following elements: a PC or PC network  872 , a remote display  874 , and a remote printer  876 . While the connections here indicate wire connections to these elements, these connections may also be wireless connections. 
         [0158]      FIG. 14B  presents the same reader as in  FIG. 14A , but the reader in  FIG. 14B  has a single test tube receiving inlet  805  instead of a rotating cassette  806  with a plurality of tube receiving inlets  805 . Reader  800  in  FIG. 14B  operates in a manner similar to reader  800  shown in  FIG. 14A . 
         [0159]      FIG. 14C , to which reference is now made, schematically shows a description of the electronics of reader  800  and its associated system in  FIGS. 14A and 14B . Detectors  912  represent: 1. an optical bar code reader and 2. at least one spectroscopic detector for determining color changes of the color bars on the urine strip and color changes in the culture media coated support on which microbial colonies have grown. Detectors  912  are well known to those skilled in the art and are readily available commercially. Measuring by the optical bar code reader and the at least one spectroscopic reader may be done concurrently or done in an alternating fashion. All readings are done directly through the walls of the test tube of the liquid testing assembly. 
         [0160]    Spectroscopy on the culture media may be carried out using chromogenic substances added by some manufacturers to commercially available media. These chromogenic agents react with known specific microbial enzymes producing well-defined detectable color changes. From the detected color changes, qualitative and semi-quantitative determination of microbial cfus can be determined. 
         [0161]    Not all culture media contain chromogenic substances or other agents that generate color changes detectable by visible spectrometry. In many cases with culture media, just cfu counts are made and this is often done using black-gray-white photometric readings. Appropriate photodetectors are readily available commercially for this purpose. 
         [0162]      FIG. 14C  shows a schematic block diagram of the electronics of reader  800  in  FIGS. 14A and 14B . Electromagnetic radiation is received by detectors  912  which, in turn, send signals to microprocessor  914  for processing. After processing, microprocessor  914  sends information related to the detected results to at least one of the following elements: a display  916 , a printer  918 , a communications network or PC  920  and a patient file  922 . Microprocessor  914  may analyze the data in many different ways and integrate it with previously obtained patient test results. 
         [0163]    Since reading is done directly through the walls of the test tube of the liquid testing assembly, there is no contact with a possibly bio-hazardous liquid or wetted urine strip. Since the urine strip and/or culture media coated support does not come in direct contact with the reader when the reading is made, cleaning the reader cassette or tube receiving inlet or other parts of the reader is not required as frequently as with prior art, commercially available, readers. Generally, in prior art readers, wetted urine strips are passed directly through the reader requiring frequent cleaning to prevent contamination. Similarly, in prior art readers bar code readers are absent as identification data is not permanently affixed to the urine strips or culture media dipslides being analyzed. 
         [0164]    The present invention also contemplates a disposable liquid testing kit. The kit comprises a liquid testing assembly as described above, a sample collection container for collecting urine from a patient, and a cannula for transferring a portion of the urine collected in the collection container to the pre-evacuated test tube or vessel of the liquid testing assembly. The liquid testing assembly may be a microbial culturing liquid testing assembly or a chemical analysis liquid testing assembly. 
         [0165]    Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. Therefore, it will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described herein above. Rather, the scope of the invention is defined by the claims that follow.

Technology Classification (CPC): 1