Testing System For Pathogens and Analytes

A device to detect pathogens and/or analytes in a test sample is designed to include a core, which may have first and second chambers. The first chamber is designed to accept a combination of a test specimen and a buffer liquid. A piston is designed to slideably engage into the first chamber of the core, wherein the end of the piston may engage with the bottom of the first chamber and be capable of grinding the test specimen. A plunger is designed to slideably engage with the second chamber of the core, and is in fluid communication with the first chamber. An assay section is attached to the core, and is in fluid communication with the second chamber. The assay device is designed to include a test strip that is capable of detecting and indicating the presence of pathogens and/or analytes in the combination of the test sample and buffer liquid.

BACKGROUND

The present disclosure relates to a testing system for pathogens.

BRIEF DESCRIPTION

In general, a testing device and related method is designed with a piston, which may include a piston chamber, a first retention portion, an annular lower portion, a pierceable layer spanning the annular lower portion's center, a textured surface at a bottom end of the piston, the piston chamber capable of retaining a fluid. A testing device may include a core, with a first core chamber, a second core chamber, a second retention portion, at least one lower drain hole, an annular grinding surface, an assay opening, and a piercing element. A testing device may include a plunger, with at least one hole plug protruding from a top portion of the plunger, a circumferential sealing element, and a retaining element; and may also include an assay section, with a test strip, an indicator window, and a plunger retaining element.

The piston may be operatively connectable to the core such that pressing the piston into the first core chamber causes the piercing element to pierce the pierceable layer, with the piston capable of rotating inside of the core chamber. The plunger may be operatively connectable to the core such that extending the plunger relative to the core removes the at least one hole plug from the at least one drain hole. The first core chamber may be capable of receiving a test specimen prior to the piston being inserted into the core, allowing the test specimen to be ground between the textured surface and the grinding surface.

The textured surface may contact the grinding surface when the piston is pressed fully into the core. The buffer liquid contained in the piston chamber may flow into the core chamber when the pierceable layer is pierced. Extending the plunger relative to the core may allow a combination of the buffer liquid and the test specimen to flow through the at least one hole from the first core chamber to the second core chamber. A combination of the buffer liquid and the test specimen may pass through the assay opening to make fluid contact with the test strip. The test strip may be configured to detect and indicate the presence of pathogens in a combination of the buffer liquid and the test specimen, where the indication may be visual and viewable on the test strip through the indicator window. Pathogens detected may be from a test specimen that is a tick.

The piercing element may include a sculpted surface. The plunger may include a base which allows the testing device to stand in a vertical position. The textured surface may be contained on a texture plate, the texture plate affixable to the annular lower portion of the piston. The pierceable layer may be positioned between the texture plate and the annular lower portion of the piston. Rotation of the piston, with the piston fully compressed into the core, may cause the test specimen to be ground and biological contents to be released into the buffer liquid. The piston's first retention portion may engage with the core's second retention portion. The assay's plunger retaining element may engage with the core's retaining element to prevent the plunger from being removed from the core.

There is also a testing device that may include a vial with a first closed end and an opposing open end, the open end capable of receiving a test specimen and a buffer liquid; a sliding member with a cap end and an opposing cylindrical end, the two ends connected by a rod, the cap end containing a slot, with a filter positioned at the end of the slot facing the cylindrical end. The sliding member may be configured to be slidable inside of the vial and capable of crushing the test specimen against the first closed end. In conjunction with the above, a lateral flow assay device may be used, with an elongated tip, the tip configured to enter the filter through the slot, the lateral flow assay device configured to detect and indicate the presence of pathogens in a combination of the buffer liquid and the test specimen.

DETAILED DESCRIPTION

The present system relates to a testing system for pathogens or analytes that may be present in a test specimen. In one embodiment, the device may be used to determine whether test specimens such as ticks contain pathogens that can cause diseases including but not limited to Anaplasmosis, Babesiosis, Ehrlichiosis, Heartland Virus, Lyme Disease, Powassan Virus, Rickettsiosis, Rocky Mountain Spotted Fever, Southern Tick Associated Rash Illness, Tick-Borne Relapsing Fever, and Tularemia. In another embodiment, the device may be used to determine whether other biological test specimens contain analytes such as pharmaceutical drugs, allergens, narcotics, non-microbial contaminants, toxins, ions, or other small organic or non-organic molecules.

The device may also be used for the preparation and testing of other test specimen and biological matter types, including but not limited to: various insect types, fecal samples, meat, fish, vegetables, legumes or fruits, grain, dirt, minerals, water, bodily tissue (as in a biopsy sample), renal calculus, hair, blood, serum, saliva, semen, synovial fluid, cerebrospinal fluid, lotion, leaf, grass, vegetation, flower, root, or stem, any which may carry a variety of pathogen types. Thus, reference to tick or insect may be interchanged with at least any of the above types for purposes of this disclosure.

Through this disclosure buffer, or buffer liquid, may refer to a common solution as known in the art. It may include buffering agents to stabilize pH, lysing agents, surfactants, and other ingredients as appropriate for an application. Embodiments in the disclosure may be manufactured by any means in the art, such as but not limited to plastic injection molding, machining, 3-D printing, etc.

Referring toFIG.1, in one embodiment there may be a vial15, which includes a closed end bottom17, with the opposing end open. Sliding member10includes two ends: at one end is cap25, and at the other is second end30, with rod20connecting the two ends. A plurality of ridges35may be present on the bottom of second end30. Filter40may be affixed to the underside of cap25. As seen inFIG.2, there may be a slot27that penetrates the depth of cap25. Slot27is positioned to align with filter40. Sliding member10is capable of sliding inside of vial15, with end30abutting bottom17, when the sliding member is fully inserted into the vial. Bottom17may include ridges18, which creates a coarse surface inside of vial15to aid in the crushing of an insect.

The inside of the closed end of vial15may be conical-shaped. Similarly, second end30with ridges35may have a similar curved surface to accelerate the process of grinding a test specimen when cap25is inserted, closed, and moved back-and-forth and/or rotated in a circular motion. Cap25may include a closure that locks into the top of vial15to ensure no spillage if the vial-sliding member assembly is in a non-vertical position.

FIG.3shows a lateral flow assay device. This includes body100with an elongated tip. The elongated tip may comprise connector115, and paper strip110. Window120may be present to display test results, as will be explained.FIG.4shows remover200, which may have two ends. At one end may be tweezer arms210, and the other end may include claw220. Claw220may have a curved fulcrum profile.

A first step in testing, such as testing a tick for various pathogens, involves crushing and sample preparation. A tick or insect is placed into vial15, and approximately 1 mL of buffer liquid is added into vial15. The buffer liquid may be provided in ampoule or other suitable container. Sliding member10is inserted into vial15, with cap25inserted into vial15and closed securely. A user then holds vial15upright and rotates (or uses and up-and-down motion) cap10a plurality of times, thereby crushing the insect and releasing its inner biological contents and any bacteria potentially within.

The next testing step involves placing tip110of the lateral flow assay device into slot27. The assembly of vial15and sliding member10is then turned 90 degrees onto its side to allow the crushed insect liquid to flow onto filter40, thereby making contact with paper tip110. Insect bacteria is carried by the buffer liquid, with any solid matter from the insect not capable of passing through filter40and reaching paper tip110. The assay device includes, internally, suitable analytic chemicals and/or mechanisms to determine the presence of pathogens of interest absorbed by paper tip110. Different analytics are used to detect pathogens of interest for specific applications. The user then waits a predetermined amount of time until a result appears in the viewing window120, either positive or negative, indicating presence or absence of a pathogen.

If an insect to be tested is attached to the body of a creature (human, dog, etc.) remover200may be used to help remove the insect. Claw20may be wedged between an insect and a creature's skin, with the insect pried away. Tweeze ends210may also be used.

FIG.5shows a perspective view of a different embodiment of a test system. Piston400may include a piston chamber435. Piston chamber400is capable of retaining a fluid, such a buffer liquid. A pierceable layer410may span the center of the annular lower portion425. Thus piston chamber435may be filled with fluid through the center of annular lower portion425(such as when the piston in is an inverted position to that shown), with pierceable layer410placed across the center opening of annular lower portion425, thus sealing the piston chamber435. Pierceable layer410may be in the form of an adhesive sticker or other suitable type. A gripping portion420may be present on piston400.

Piston400may be configured with a textured surface405its bottom end. The textured surface may be part of piston400itself, or may be a separate texture plate422that can be affixed to piston400. Texture plate422may be affixed to piston400after the pierceable layer410is applied to the annular lower portion425. A separate texture plate422can be seen inFIG.6andFIG.9.

The exploded view ofFIG.6shows that piston400may be configured to slideably engage with a first core chamber475of core440. The lower portion of first core chamber475is configured to include an annular grinding surface485, best seen inFIG.8. A piercing element450is configured in the center of annular grinding surface485, extending upwards. Piercing element450may be configured to include sculpted surface455which may aid in the grinding of a test specimen600(test specimen600not shown in other views, for clarity), as will be detailed. At least one lower drain hole460is present on annular grinding surface485—with four holes shown in the various figs herein.

FIG.6also shows first retention portion430(on piston400) with second retention portion470(on core440). First retention portion430may be wedged-shaped, using a ramped profile that allows430to snap into second retention portion470, when piston400is inserted into core440. Second retention portion470may be in the form of a circumferential groove on the inside of core440. This allows piston400to be inserted into core440one-time, with the piston not readily removable once the protruding first retention portion430engages into the groove of second retention portion470.

Core440may be configured with a second core chamber480, positioned below first core chamber475. The two chambers475and480are in fluid communication with each other through at least one lower drain hole460. Second core chamber480is configured with an assay opening465, which allows fluid communication with assay section518, including test strip520. Test strip520may be of any suitable type known in the art. It may be made of nitrocellulose paper, or other suitable material.

The exploded view ofFIG.6also shows that plunger490may be configured to slideably engage with a second core chamber480of core440. Plunger490may be configured to include at least one hole plug495protruding from a top portion. The number of plugs495matches the number of drain holes460, with plugs495sealing holes460when plunger490is fully inserted into core440. A circumferential sealing element500sits in a grove on the upper portion of plunger490, to create a seal inside second core chamber480. Element500may be in the form of an O-ring, made from rubber, plastic, or other suitable material. Plunger490may also include gripping hole505, and base510—the latter allowing the overall device to stand in a vertical orientation.

ReferencingFIG.8, assay section518may be configured to include test strip520, and indicator window525. Assay section518is affixed to the side of core440. Assay opening465(on core440) allows test strip520to be in fluid communication with second core chamber480.FIG.7shows plunger retaining element515(on plunger490), and retaining element530(on assay518)—these elements work together to limit travel and prevent plunger490from being fully removed from core440, with retaining element530not allowing plunger retaining element515to travel past. In manufacturing, plunger490is inserted into core440prior to assay section518being affixed to core440.

The system may be designed to function in a number of different ways, including the following. A user begins with the system as configured from manufacturing with plunger490fully seated into core440, assay section518affixed to core440, with piston400separated from core440. Piston chamber435contains an appropriate amount of buffer liquid, which was installed during manufacturing, with pierceable layer410sealing the buffer liquid in piston chamber435.

A user places a test specimen such as600into first core chamber475, wherein it rests on annular grinding surface485, which may include a textured surface. Piston490is then fully inserted to first core chamber475. Such insertion causes piercing element450to pierce pierceable layer410, causing the buffer liquid to be released into first core chamber475. Sculpted surface455on piercing element450in part allows the buffer liquid to flow into the chamber.

A user imparts motion to piston400, while holding the core in place. Motion may be rotations of piston400and/or an up-and-down motion—both serve to grind the test specimen between textured surface405and annular grinding surface485. The dimension of first retention portion430relative to the groove on second retention portion470may be such that a small amount of up-and-down motion is possible, with430movable within470. After the test specimen is ground as desired, the inner biological contents of the test specimen (such as insect internal matter and pathogens) will form a combination with the buffer liquid.

The user then extends plunger490relative to core440, which removes the at least one hole plug495from the at least one lower drain hole460, causing the combination to drain into second core chamber480. The combination may then travel through assay opening465. This allows the combination to be in fluid contact with test strip520. Retaining element515in combination with plunger retaining element530prevents plunger490from being over-extended and removed from core440.

The test strip includes, internally, suitable analytic chemicals and/or mechanisms to determine the presence of pathogens of interest absorbed by the test strip. Different analytics are used to detect pathogens of interest for specific applications. The user then waits a predetermined amount of time until a result appears in the indicator window525, either positive or negative, indicating presence or absence of a pathogen.

Although the present system has been described with respect to one or more embodiments, it will be understood that other embodiments of the present system may be made without departing from the spirit and scope of the present system. Hence, the present system is deemed limited only by claims and the reasonable interpretation thereof.