JP2008541009A - Apparatus and methods for sample collection and analysis - Google Patents

Abstract

  The present invention provides devices, methods, and kits for the collection of solid or semi-solid samples and analysis for the presence, absence, or amount of analyte. The present invention provides a collection slide having a first card and a second card. The first card has a sample collection area. The first and second cards have orifices that allow passage of fluid through the sampling area, and the cards are connected to each other by hinges. The present invention further provides an assay device having a housing comprising a test element, a result window, and a docking area for receiving and engaging a collection slide. In one embodiment, collection slides and devices can be used to detect the presence of fecal occult blood (human hemoglobin) in a stool sample. Numerous other embodiments are disclosed herein.

Description

  The present invention relates to an apparatus for taking solid or semi-solid biological samples and analyzing those samples for the presence of an analyte.

  The following background of the present invention is intended to facilitate the understanding of the present invention for the reader and is not admitted to be prior art.

  Detection of occult blood in a stool sample is the first method for detecting colon cancer. Traditional methods for detecting hemoglobin in stool samples, such as the guaiac chemical method, cannot distinguish between hemoglobin derived from food (ie from dietary meat) and human hemoglobin The result is a large number of false positive test results. In order to overcome this difficulty, immunoassays specific to human hemoglobin (hHb) have been developed. The antibodies used in these assays can distinguish between hemoglobin from humans and hemoglobin from other animals.

  The collection and analysis of occult blood samples presents the problem that sample collection and analysis is uncomfortable. Currently available devices do not adequately solve these problems. Thus, there is a clear and long-standing need for a device that accurately detects the presence of hHb in a sample while reducing both sample and patient involvement with the sample.

  The present invention provides devices, methods and kits for the collection and analysis of biological samples. In one embodiment, the biological sample is a stool sample. One embodiment of the present invention is a collection slide having two cards connected by a hinge. There is a sample collection area on the inner surface of the card for depositing biological samples. The card further includes an orifice so that the buffer can be passed through the card and sample collection area to elute the analyte from the sample contained on the card. Furthermore, the present invention provides an apparatus for detecting an analyte in a biological sample. The apparatus includes a test element such as a test strip having a reagent for detecting an analyte. The device further includes a docking area for receiving the collection slide. A sample transfer orifice having an absorbent transfer material is present in the docking area, and the absorbent transfer material receives the buffer that has passed through the orifice of the collection slide and passes the eluted fluid to the test element.

  In a first aspect, the present invention provides an apparatus for detecting an analyte in a sample. The apparatus has a housing containing a test element and a docking area on the housing that receives and engages a sampling slide. The docking has a sample transfer orifice, and an absorbent transfer bead disposed within the sample transfer orifice is in fluid communication with the test element. Furthermore, the apparatus has a result window for observing the inspection result.

  The transfer material can be made of various materials or shapes. In various embodiments, the transfer material is ultra high molecular weight polyethylene, polyethylene, polyurethane, nylon, polyester, polypropylene, polytetrafluoroethylene, or a cellulose-based material. In one embodiment, the transfer material is an ultra high molecular weight polyethylene filter.

  In one embodiment, the sample transfer orifice of the device is a well located within the device housing. The well is a recess in the housing and functions to collect fluid overflowing from the absorbent transfer material. Further, the absorbent transfer material can include reagents for improving the transfer of analyte from the collection slide to the test element. In one embodiment, the transfer material comprises a reagent selected from the group consisting of a surfactant, protein, buffer, polymer, and preservative. A “surfactant” is a compound that reduces the surface tension between two liquids. Surfactants can include hydrophilic (attracting water) groups and hydrophobic (water repelling) groups. A “protein” is a macromolecule composed of one or more chains of amino acids in a particular order and folded shape determined by the nucleotide sequence of the gene encoding the protein. The “buffer” is a solution containing a weak acid and a salt thereof, or a weak base or a salt thereof, and is resistant to changes in pH. A “polymer” can be any of a large number of high molecular weight natural and synthetic compounds, usually consisting of millions of repeating chain units, each of which is a relatively light and simple molecule. . A “preservative” is an additive used for protection against deterioration, discoloration, or damage.

  In other embodiments, the transfer material includes a reagent. In various embodiments, the reagent may be any one or more of a blocking agent, surfactant, wetting agent, solubilizer, stabilizer, diluent, and preservative. A “blocking agent” may be any of a number of compounds or substances that block binding of an analyte to a support medium by binding to the analyte or support medium. A “wetting agent” is an organic-based material that typically helps to change the surface tension of a liquid and provide a uniform coating on difficult to wet or hydrophobic surfaces. A “stabilizer” is a compound that prevents degradation of the tertiary structure of the compound. For example, compounds can be added to the collection slide to prevent degradation of Hb molecules in the sample or specific binding molecules in the device.

  In a further embodiment, the transfer beads are BRIJ® 35, Chemical LA-9, Pluronic® L64, Surfactant 10G, Span® 60, Silwet® L7600, Rhodasurf ON- 870, Cremohor (registered trademark) EL, Tween (registered trademark) 20, Tween (registered trademark) 80, Surhynol (registered trademark) 485, Igepal (registered trademark) CA210, Triton (registered trademark) X-45, Triton (registered trademark) ) X-100, Triton (registered trademark) X-305, Bio-Terge (registered trademark) AS-40, Standard pol ES-1, benzalkonium chloride, Tetronic (registered trademark) 1307, Suryn l (registered trademark) 465, Ninate (registered trademark) 411, Pluronic (registered trademark) F69, Zonyl (registered trademark) FSN 100, AEROSOL (registered trademark) OT 100%, Geropon (registered trademark) T77, sodium dodecyl sulfate, taurocol Sodium salt, sodium cholate, CTAB, LDAO, CHAPS, NP40, n-octyl saccharose, n-dodecyl saccharose, n-dodecyl maltoside, octyl glucoside, octyl thioglucoside, n-hexyl glucoside, n-dodecyl Glucoside, Tris (hydroxymethyl) aminomethane buffer, phosphate buffer, borate buffer, tartaric acid buffer, phthalic acid buffer, PVP K-30, PVP K-9 , GANTREZ (registered trademark) AN-119, polyethylene oxide, polyethylene glycol, PEG 800, GANTREZ (registered trademark) AN-119, polyvinyl alcohol, PVP / VA S630, teleost gelatin, crosslinked polyacrylic acid polymer, hydroxypropyl cellulose, Contains a reagent selected from the group consisting of sodium carboxymethyl cellulose, sodium polystyrene sulfate, sodium carrageenin, acrylic acid latex, hydroxyethyl cellulose, bovine serum albumin, ovalbumin, casein, ProClin® 300, and sodium azide .

  In other embodiments, the test element is an absorptive matrix that resides within the housing and has a sample application area in fluid communication with the absorbent transfer material. The test element has a reagent region that contains a reagent for performing the assay and a detection region that has a test line and visually detects the presence or absence of the analyte at the test line. The test line can have specific binding molecules for the analyte immobilized on the matrix. In one embodiment, the analyte is human hemoglobin and a specific binding molecule on the test line binds to human hemoglobin. The reagent region is an antibody in one embodiment, but can include a labeled specific binding molecule for the analyte. Specific binding molecules can be present in a dry state and can be solubilized by passing through the sample fluid. In other embodiments, the test line has a reagent for performing a chemical test.

  In certain embodiments, the docking area has one or more mating locks for holding the sample collection slide in place within the docking area. For example, the docking area can have a protrusion for securing the sample collection slide in place above the absorbent transfer pad. By “fit lock” is meant one or more protrusions that tightly fit a collection slide. That is, when the collection slide is moved to a predetermined position, the collection slide passes the “fitting lock” and “fits” into the predetermined position. The protrusion can protrude into the area of the docking area. Further, the docking area may be an area in which the collection slide is inserted by a slide motion. In either embodiment, the eluent orifice of the collection slide is placed in fluid communication with the absorbent transfer material. The docking area can exist as a recess or recess in the housing that is at least partially surrounded by an elevated area of the housing. Alternatively, the docking area may be present as an elevated part of the housing.

  In another aspect, the present invention provides a collection slide for sample collection and transfer. The collection slide has a first card having an inner surface and an eluent orifice, and a second card connected to the first card by a hinge and having an inner surface and a solvent orifice. The collection slide has an open position and a closed position, and the solvent orifice and the eluent orifice are aligned when the collection slide is in the closed position. The collection slide further has a sample collection pad on the first card on which the sample is applied for collection. In one embodiment, a sample collection pad is present between the solvent orifice and the eluent orifice when the collection slide is in the closed position. The first and second cards can be made of a water resistant material or a water impermeable material. In one embodiment, the first and second cards are made of plastic.

  In one embodiment, the sample collection area further comprises a collection pad overlying the eluent orifice of the first card, and the sample application area is at least partially surrounded by a sealing structure on the first card. It is. The second card can have a cover pad overlying the solvent orifice, and the second card has a sealing structure that is complementary to the structure on the first card. In one embodiment, the structure on the first card is a gasket and engages the structure on the second card that is a groove when the sampling slide is in the closed position. Two structures "engage" means that their interaction forms a barrier that prevents sample movement into and out of the sample collection area. The “sealing structure” is a structure that prevents movement of the sample entering and exiting the sample collection area when engaged. In other embodiments, the first card can have a groove and the second card can have a gasket. Some embodiments also utilize other structures, such as a heel or other structure that is generally sealed when the first and second cards are in the closed position. In a further embodiment, in order to keep the slide in the closed position, the first card or the second card includes one or more holes for receiving protrusions from the second card or the first card, respectively. . The cover pad and sample collection pad can be made of any suitable material. In some embodiments, the cover pad and sample collection pad are made of a fibrous material or an absorbent material.

  In other embodiments of the collection slide, the cover pad and / or the collection pad contain reagents for eluting the analyte from the sample. In certain embodiments, the reagent is one of a surfactant, buffer, protein, polymer, and preservative, or a blocking agent, surfactant, wetting agent, solubilizer, stabilizer, diluent, and preservative. There may be more than one. Examples of useful reagents include BRIJ® 35, Chemical LA-9, Pluronic® L64, Surfactant 10G, Span® 60, Silwet® L7600, Rhodasurf ON-870, Cremohor ( (Registered trademark) EL, Tween (registered trademark) 20, Tween (registered trademark) 80, Surhynol (registered trademark) 485, Igepal (registered trademark) CA210, Triton (registered trademark) X-45, Triton (registered trademark) X-100 Triton (registered trademark) X-305, Bio-Target (registered trademark) AS-40, Standapol ES-1, benzalkonium chloride, Tetronic (registered trademark) 1307, Surynol (registered trademark) 465, inate <(R)> 411, Pluronic <(R)> F69, Zonyl <(R)> FSN 100, AEROSOL <(R)> OT 100%, Geropon <(R)> T77, sodium dodecyl sulfate, sodium taurocholate, sodium bileate, CTAB, LDAO, CHAPS, NP40, n-octyl saccharose, n-dodecyl saccharose, n-dodecyl maltoside, octyl glucoside, octyl thioglucoside, n-hexyl glucoside, n-dodecyl glucoside, tris (hydroxymethyl) aminomethane buffer, Phosphate buffer, borate buffer, tartaric acid buffer, phthalate buffer, PVP K-30, PVP K-90, GANTREZ (registered trademark) AN-119, polyethylene Koxide, polyethylene glycol, PEG 800, GANTREZ (registered trademark) AN-119, polyvinyl alcohol, PVP / VA S630, teleost gelatin, cross-linked polyacrylic acid polymer, hydroxypropylcellulose, sodium carboxymethylcellulose, sodium polystyrene sulfate, sodium carragee Nin, acrylic acid latex, hydroxyethyl cellulose, bovine serum albumin, ovalbumin, casein, ProClin® 300, and sodium azide.

  In another aspect, the present invention provides a method for detecting the presence or absence of an analyte in a sample contained in a sample collection slide. The method includes placing a collection slide containing a sample into a docking region of a device for detecting an analyte in the sample. The devices and collection slides used in the method are any of the devices and collection slides described herein. Further steps of the method include adding extraction buffer to the solvent orifice of the collection slide, allowing passage of the extraction buffer through the sample area to the absorbent transfer beads and test element, and checking in the result window. Including observing the results.

  In other embodiments, the present invention provides kits for the collection and analysis of biological samples. In one embodiment, the kit includes at least one collection slide as described herein, and a device for detecting an analyte in a fluid as described herein. These are provided in a package. In a further embodiment, the kit is provided in a package with one or more sample collectors as described herein, a bag for containing the collection device after collection, and for use Instructions can be included. In various embodiments, the kit can include a sample collection slide, a device, and any one or more of the additional components described above. Either kit can further include one or more bottles containing a buffer for performing the assay according to the instructions for use. In one embodiment, the instructions for use are instructions for detecting the presence of hemoglobin in the stool sample.

  In another aspect, the present invention provides a method for collecting a sample. The method includes contacting a sample applicator loaded with a sample to a sample collection pad of a collection slide as described herein, and placing the collection slide in a closed position. In some embodiments, the method further comprises placing a closed collection slide containing the collected sample in a bag or drying chamber. Placing the collection slide in the closed position means pressing the first card and the second card together to engage one or more protrusions into one or more holes and place the collection slide in the closed position. A fixing step can be included. By placing the collection slide in the closed position, excess sample can be removed from the sample collection pad.

  In one embodiment, the sample collection applicator is a tool having a portion for collecting a sample, and the portion for collecting the sample has a plurality of holes for discharging a fluid portion of the sample. . In one embodiment, the site for collecting the sample is primarily flat.

  The present invention includes various other useful aspects that are described in detail herein. Those aspects of the invention can be realized by using the products and compositions described herein. It will be further understood by reference to this disclosure that various aspects of the invention can be combined to create desirable embodiments of the invention. Furthermore, various other aspects and embodiments of the invention are described herein.

  The summary of the invention described above is not intended to limit the invention, and other features and advantages of the invention will be apparent from the following detailed description, and from the claims.

  In the following detailed description, references are made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration specific embodiments in which the invention may be implemented. It should be understood that other embodiments may be utilized and structural changes may be made without departing from the scope of the present invention.

Collection Slide The present invention provides a collection slide for collecting a solid or semi-solid sample. In some embodiments, the sample is a biological sample, such as a stool sample. Furthermore, the present invention provides an apparatus for detecting the presence of an analyte in a sample and a method for taking a sample.

  Referring to FIGS. 1 to 5, the collection slide 110 has a first card 114 and a second card 112. The first and second cards can be made of any suitable material. For example, the card can be made of an elastic, water resistant or water impermeable material such as plastic, coated paper, metal, or glass. In one embodiment, the cards are hingedly connected to each other, for example by a hinge 224 (FIG. 2). “Hinged connection” means that two cards are connected to each other at their first end and the free ends can be moved towards each other by movement about the hinge and moved away from each other Means that you can. A wide variety of hinge connections can be used to advantage. In the illustrated exemplary embodiment, the collection slide is manufactured by plastic injection molding, and the two cards are connected by a living hinge as shown in FIG. In other embodiments, the hinge may be one or more flaps of material that tie the two cards together and allow one card to be folded into the other. In another embodiment, the card exists as a separate card that can be secured together, for example by a locking mechanism. The second card has a buffer or solvent orifice 116 through which the extraction buffers 510, 512 can be added to the collected sample (FIGS. 1 and 5).

  The collection slide has an open position and a closed position (compare FIGS. 1 and 2). As shown in FIG. 2, the first card has an eluent orifice 210 and the second card has a solvent orifice 116. The buffer orifice and eluent orifice are positioned on the card so that the two orifices are aligned when the collection slide is in the closed position. Orifice “alignment” means that a sufficient amount of liquid added to the solvent orifice of the second (ie, upper) card passes through the sample collection area and the eluent orifice.

  Referring to FIG. 2, a cover pad 218 is present on the inner surface of the second card and overlies the buffer orifice 116. The cover pad and sample collection pad can be made of any suitable material that holds the sample and allows fluid to pass through. Examples of suitable materials for the cover pad and / or sampling pad are polyester mesh, fibrous or absorbent material, paper or paper-based material, synthetic fiber, mesh and wool, coated paper or supported paper Polyester, nylon film, nitrocellulose, glass wool, treated paper, absorbent paper, or a material mainly made of cellulose. In the illustrated embodiment, the cover pad 218 is surrounded by the gasket 220. By referring to the present disclosure, one of ordinary skill in the art will appreciate numerous other materials suitable for the cover pad and / or sample application pad.

  The first card has an eluent orifice 210, and a sample collection pad 216 is overlaid on the eluent orifice 210. The sample collection pad 216 can be made of any suitable material that holds the sample and allows fluid to pass through. In various embodiments, the sample collection pad 216 is made of the same type of material as the cover pad. The sample collection pad can be surrounded by ridges 214 and grooves 212, or can be surrounded by a series of ridges and grooves. The cover pad and collection pad can be made of any suitable material that holds the sample and allows fluid to pass through. Examples have been described above for cover pad materials. In addition, the material must be sufficiently resilient to withstand the mechanical pressure of sample application. Preferably, it should not deteriorate or tear due to wetting.

  A common difficulty in collecting stool samples is that patients tend to overcoat samples onto collection slides, which can cause interference when the assay is an immunoassay. The collection slide of the present invention limits the amount of sample that can be applied to the slide, while the technician performing the test does not need to manipulate the sample directly. When the slide is in the closed position, the amount of sample collected is limited to the sample collection area because the cover pad and sample collection pad are surrounded by a sealing structure (eg, gasket and groove). When moving the collection slide to the closed position, due to the interaction of the sealing structure (eg interaction with gasket grooves and ridges), the sample in the sample application area separates from the sample applied outside the sample area Is done. After the sample has been applied to the sample collection area, the collection slide is closed and held in the locked position so that when the two cards are pressed together, excess sample is squeezed out and held in the sample area. The amount of sample that can be used is limited. The sealing structure may be a structure other than a gasket, a ridge, and a groove. For example, this structure is present on or around the sample collection pad and / or cover pad, and a pressure sensitive adhesive that seals the sample collection pad when two cards are closed and pressed together Or it may be (one or more) wax beads. The “sealing” does not necessarily need to be a tight seal, but only generally prevents the sample from entering or exiting the sample collection area when the collection slide is in the closed position. With reference to this disclosure, one of ordinary skill in the art will recognize numerous other structures that may be used in other embodiments of the present invention.

Cover pads and / or collection pads can be treated with reagents that improve the flow of aqueous liquid therethrough. Furthermore, such treatment improves the elution of the analyte of interest from the dry sample in the sample area. In one embodiment, the pad is treated with a surfactant to inhibit protein adhesion to the pad and promote protein solubilization. A variety of commonly used anionic and nonionic surfactants can be advantageously used at various concentrations. Several cationic and amphoteric surfactants can also be used in the present invention. Some examples of surfactants that can be used to treat pads include, but are not limited to, polyoxyethylene fatty acid ethers derived from various alcohols such as lauryl, cetyl, stearyl, and oleyl (eg, BRIJ (Registered trademark) series of surfactants (ICI US, Inc.)). Other useful surfactants include the series of octylphenol ethoxylate surfactants (eg, polyethylene glycol mono-p-iso-octylphenyl ether, and other Triton® (Rohm & Haas, Philadelphia, PA) Surfactants), polyoxyethylene derivatives of sorbitan esters (for example, surfactants of the series Tween® (ICI Americas, Inc.)), and HO (C ₂ H ₄ O based on ethylene oxide and propylene oxide). _{) a (C 3 H 6 O} ) b (C 2 H 4 O) a block copolymer represented by _a H (e.g., Pluronic (R) (BASF) as the series of surfactants) and the like. With reference to the present disclosure, known surfactant activity, such as using commercially available surfactant tool kits (eg, Reagent Developer's Tokyo Kit (Pragmatics, Inc., Elkhart, Indiana), or similar kits) Surfactants can be conveniently selected using agent selection techniques. These kits provide a convenient way to test a large number of surfactants for specific applications in order to optimize protein extraction and flow-through.

  In some embodiments, the pad can be treated with a buffer that includes components that enhance the stability of the analyte. In addition, the buffer can adjust the sample to facilitate optimal binding between the analyte and a particular binding reagent (eg, antibody or antibody fragment) that can be used in the assay. This can be done, for example, by adjusting the pH of the analyte. Buffers having such useful properties include, but are not limited to, tris (hydroxymethyl) aminomethane buffer, phosphate buffer, borate buffer, tartrate buffer, and phthalate buffer.

  A “specific binding molecule” refers to a molecule that binds to an analyte of interest (eg, human hemoglobin) and does not substantially bind to other molecules present in the sample. In some embodiments, a specific binding molecule may bind to a molecule that correlates with the presence of the analyte of interest in the sample or a molecule that indicates the presence of the analyte in the sample. Substantial binding means that the binding will affect the results of the assay performed by the specific binding molecule, ie, to the extent that results in suboptimal or less accurate results. Small amounts of non-specific binding that may occur but do not change the results of the assay are not considered substantial binding. In some embodiments, the specific binding molecule is an antibody or antibody fragment (eg, an antibody Fab region), an antigen, a receptor or a fragment of a receptor that binds a ligand, or a biotin-streptavidin pair or others. May be a member of any type of binding pair.

  Furthermore, the cover pad and / or the sample application pad can be treated with one or more polymers that can also have properties that improve analyte stability and dissolution. Polymers sometimes used in protein purification can be used for this purpose. Examples of useful polymers include, but are not limited to, polyvinyl pyrrolidone (PVP), poly (methyl vinyl ether-co-maleic anhydride), polyethylene oxide (PEO), polyethylene glycol (PEG), methyl vinyl ether And maleic anhydride copolymers (eg, poly (methyl vinyl ether-co-maleic anhydride)), polyvinyl alcohol (PVA), vinyl pyrrolidone / vinyl acetate, teleost (from the teleost class fish) Gelatin, cross-linked polyacrylic acid polymer, hydroxypropyl cellulose (HPC), sodium carboxymethyl cellulose (CMC), sodium polystyrene sulfate, sodium carrageenan, acrylic acid latex, and hydroxyethyl cellulose (HEC) It is below. These polymers are commercially available (eg, from Pragmatics, Inc., Elkhart, Indiana) and are conveniently formulated in polymer toolkits. They can therefore be used systematically to determine the advantages of a particular polymer in a particular application.

  To improve analyte extraction, the pad can be further treated with a non-specific protein that functions as a blocking agent. Any protein can be used for this purpose such as, but not limited to, bovine serum albumin, ovalbumin, and casein.

  Furthermore, the cover pad and sample application pad can be treated with preservatives to extend the shelf life of the collection slide. A “preservative” is a natural or artificial chemical that is added to inhibit microbial growth or undesirable chemical changes. Any preservative that provides a preservative effect and does not interfere with the assay can be used. Examples of useful preservatives include, but are not limited to, 5-chloro-2-methyl-isothiazol-3-one (eg, ProClin® 300 (Supelco, Inc., Bellefonte, PA)). By reference to the present disclosure, one of ordinary skill in the art will appreciate many other preservatives that can be used in the present invention.

  The cover pad and sample collection pad function to form the upper and lower walls of the sample collection area and remove excess samples from the sample collection area. If the structure on the card is a gasket, ridge, or groove, they may be placed on a card opposite to the card described above.

  In certain embodiments, one of the cards on the collection slide is provided with a structure for securing the first and second cards in the closed position. In one embodiment, short pins 316 (FIG. 3B) are present on the inner surface of one card. The other card is provided with holes 318 that match these pins. When the collection slide is closed, a pin is inserted into the hole and caught with sufficient resistance to hold the collection slide in the closed or “locked” position. In one embodiment, this action can advantageously produce a snapping sound that informs the patient that the collection slide has been properly closed. Other methods of securing the collection slide in the closed position can be incorporated into the slide. For example, in one embodiment, a clip can be used that is attached to the outside of two cards to hold the two cards together, or in other embodiments, a snap that is present on the inner surface of the two cards. Can be used. By referring to the present disclosure, one of ordinary skill in the art will appreciate other structures for holding the collection slide in the closed position.

Sample Collector The present invention also provides a sample collector 134 (FIG. 1). The sample collector has a handle 314 (FIG. 3B) and a spatula 312 for moving the sample. In one embodiment, the spatula is perforated with a plurality of holes that serve to reduce the amount of sample liquid and also reduce the application of excess sample to the sample collection pad. In various embodiments, the spatula portion of the device has four, five, six, seven, eight, nine, ten, eleven, twelve, or more holes. The spatula portion of the harvester may be generally flat or may have a curved (spoon-like) shape. The device can be made of any suitable material (eg, plastic). In one embodiment, the spatula portion of the device is made of a flexible plastic and the handle is made of a harder plastic. This allows the spatula to bend when the sample is applied to the sample collection pad and smeared onto the pad. The holes in the spatula part also serve as an aid in applying the sample evenly to the pad.

Collection Method Another aspect of the present invention is a sample collection method. In one embodiment, the sample is a stool sample. The method of sample collection and the operation of the collection slide and the assay device are shown in FIGS. 3A-3C.

  One embodiment of the method is shown in FIG. 3A. The patient opens the collection slide to expose the inner surfaces of the first and second slides, exposing the cover pad and sample collection pad. A small amount of stool sample is applied to the sample collection pad 216. The collection slide is then closed (FIG. 3C). The collection slide of the present invention removes excess samples by providing a sample collection area with a design such that only samples within the sample collection area are taken into the assay. When the collection slide is closed, the structure of the first card engages the structure of the second card, forming a wall surrounding the sample collection area. In one embodiment, the structure on one card is a gasket and the structure on the other card is a groove and a ridge. When the collection slide is in the closed position, the solvent or buffer orifice, the sample area, and the eluent orifice are all aligned vertically. In this state, when buffer is added to the buffer orifice, the buffer flows through the cover pad to the sample collection area and then out of the eluent orifice, thereby washing the sample in the process and into the sample. The analytes of interest included are solubilized. In addition, the buffer dilutes the sample and adjusts the sample for optimal binding of the analyte by a specific binding reagent on the test element. After passing through the eluent orifice, the liquefied sample passes to the absorbent transfer beads of the assay device.

  It is known that human hemoglobin degrades rapidly when left in wet samples. To prevent analyte degradation, the method can incorporate a step of drying the sample. This step can include leaving the collection card exposed to air for a period of time to allow air drying, or drying the sample in a 45 ° C. oven. This stage may also include placing the closed collection slide in a container containing a desiccant. The container may be a sealable bag (eg, a mailing bag). After drying (or after the collection slide is placed in a sealable bag with a desiccant), the collection slide can be presented to a medical health facility for analysis.

Assay Device Another aspect of the present invention relates to an assay device 120 for analyzing a sample in a collection slide for the presence or absence of the analyte of interest (see FIGS. 1 and 2). One embodiment of the assay device is shown in FIGS. In this embodiment, the assay device has a housing composed of an upper part 122 and a lower part 124 that are engaged with each other and fixed together. The housing can be composed of any suitable material such as, for example, plastic, pressed paperboard, metal, ceramics, polymers (eg, polycarbonate, polypropylene, cycloolefin), and other materials. In the illustrated embodiment, the housing is made of molded plastic. The top and bottom can be engaged with each other by any convenient means such as mating parts, adhesives, microwelds, and other means. In the embodiment shown in FIG. 2, the top has a series of pins (not shown) on the inner surface that fit snugly into a corresponding series of raised rings 228 on the bottom inner surface 230; The upper and lower parts of the assay device are fixed in a locked state.

  A docking area 126 for receiving the sampling slide and engaging with the sampling slide is located on the assay device. The collection slide can be “loaded” in the sense of containing the sample to be analyzed. The docking area can be of any shape and can coincide with the portion of the collection slide that holds the sample collection area. In one embodiment, the docking area can receive and engage an external collection slide. An external collection slide is a collection slide that can be loaded away from the assay device and is not physically connected to the device at the time of sample loading. “Receiving and engaging with” the collection slide means that the assay device and the collection slide are in the “test position”. The “inspection position” is a state where the sample application pad and the absorbent transfer material are in fluid communication.

  In addition, the docking area can accept the collection slide in a reversible manner, i.e., after the sample is eluted from the collection slide by applying a buffer, the collection slide can be removed from the device. As shown in FIG. 4, in this embodiment, the collection slide is fitted into the docking area by placing the hinged edge of the collection slide below the tongue 410. The collection slide is then pushed down into the docking area and snapped into the locked position below one or more protrusions 412. A protrusion holds the collection slide flush with the docking area. In other embodiments, the docking area is slid to the assay device. In one embodiment, the docking area may have a site that fits above the collection slide to hold the collection slide in place. When in place, the sample collection pad and the absorbent transfer material are in fluid communication. The buffer orifice is exposed to receive the buffer, and the buffer applied to the buffer orifice passes through the sample collection pad to the absorbent transfer material. In one embodiment, the docking area is configured to receive the collection slide against the outer surface of the assay device such that the sample collection area and the absorbent transfer member are in fluid communication. The docking area may have a protrusion for holding the collection slide and fixing it in the inspection position.

  In other embodiments, the docking area can receive the collection slide into the interior of the device. In another embodiment, the sample transfer orifice is the only orifice of the assay device for receiving the sample or assay fluid, and both the sample and the assay fluid pass through the sample transfer orifice. “Assay fluid” refers to a buffer or other reagent utilized in the assay. Thus, in these embodiments, the sample transfer orifice is the only orifice for receiving sample and fluid into the device.

  As shown in FIG. 1, in one embodiment, the docking region includes a recess or well 130 having a transfer material 132 disposed therein. The absorbent transfer material can take any form, such as a bead, cube, cylinder, ellipse, or any shape, and can be located inside the well. As shown in FIG. 2, the transfer material protrudes through the top of the housing and the orifice 226 and is generally coplanar with the plane of the docking area or slightly through the plane of the docking area. Sticks out. In the present embodiment, the absorbent transfer material is absorbent transfer beads. Referring to FIG. 6, when the collection slide is inserted into the docking area, the buffer orifice, cover pad, sample collection pad, eluent orifice, and absorbent transfer beads are all aligned generally perpendicular to each other. In this embodiment, the absorbent transfer bead protrudes into the plane of the docking region or passes through the plane of the docking region, so the absorbent transfer bead and the outer surface of the sample collection pad are It is placed in fluid communication through the eluent orifice. “Fluid communication” means that fluid passing through the sample collection area and sample collection pad is passed to the absorbent transfer material. The sample collection pad and absorbent transfer material may be in direct physical contact, or may be kept in fluid communication, although slightly separated from each other.

  The absorbent transfer material can be comprised of a variety of useful absorbent materials. This material must be able to carry liquid from the collection slide to the test element of the assay device without changing the sample in such a way as to interfere with the assay results. Examples of suitable materials for absorbent transfer materials include, but are not limited to, filter paper or other paper based filter materials, nylon mesh filters, cellulose filters (or made of cellulose based materials). Filter), polyester filter, and glass wool filter. In other embodiments, the absorbent transfer beads are made of ultra high molecular weight polyethylene (UHMWPE), polyethylene, polyurethane, nylon, polyester, polypropylene, or polytetrafluoroethylene. In a further embodiment, the transfer material is a filter made of an ultra high molecular weight polyethylene filter.

In various embodiments, the absorbent transfer material can be treated with a reagent that improves analyte transfer from the collection slide to the test element of the assay device. The transfer material can be treated with any of the reagents described above with respect to collection slide cover pad and sample collection pad processing. Examples of reagents that can be used to treat cover pads, sample collection pads, and absorbent transfer materials include, but are not limited to, polyoxyethylene (23) dodecyl ether, polyoxyethylene (9) lauryl alcohol, Poly (oxyethylene-cooxypropylene) block copolymer, p-isononylphenoxy-poly (glycidol), anhydrous sorbitol monostearate, polydimethylsiloxane methyl ethoxylate, polyethoxylate (20) oleyl alcohol, polyethoxylate (35) Castor oil, polyoxyetherene (20) sorbitan monolaurate, octylphenol ethoxylate (1.2), octylphenoxypolyethoxy (5) ethanol, octylphenoxypolyethoxy (9-10) Ethanol, octylphenoxy polyethoxy (30) ethanol, sodium olefin _(C 14 _{-C 16)} Soruhon salt, sodium polyoxyethylene (1) lauryl sulfate, benzalkonium chloride, ethylene diamine alkoxylate block copolymer, 2,4 , 7,9-tetramethyl-5-decyne-4,7-diol ethoxylate (10), 2,4,7,9-tetramethyl-5-goodwetter decyne-4,7-diol ethoxylate (30 ), Amine alkylbenzene sulfonate, poly (oxyethylene-co-oxypropylene) block copolymer, telomer B monoether, sodium dioctylsulfo-succinate, poly (vinyl methyl ether / maleic anhydride) copolymer, sodium N -Oray Ru-N-methyl taurate, dodecyl sulfate, sodium taurocholate, sodium bile acid, N-citrtrimethylammonium bromide, N, N-dimethyldodecylamine N-oxide, 3- [3- (colamidopropyl) dimethylammonio ] 1-proan sulfonate, alcohol ethoxylate, n-octyl saccharose, n-dodecyl saccharose, n-dodecyl maltoside, octyl glucoside, octyl thioglucoside, n-hexyl glucoside, n-dodecyl glucoside, tris (hydroxymethyl) amino Methane buffer, phosphate buffer, borate buffer, tartrate buffer, phthalate buffer, polyvinylpyrrolidone homopolymer, poly (vinyl methyl ether / maleic anhydride), polyethylene oxide, poly Ethylene glycol, polyvinyl alcohol, 1-ethenyl-2-pyrrolidinone, teleost gelatin, crosslinked polyacrylic acid polymer, hydroxypropylcellulose, sodium carboxymethylcellulose, sodium polystyrene sulfate, sodium carrageenan, acrylic acid latex, hydroxyethylcellulose, bovine serum Examples include albumin, ovalbumin, casein, 5-chloro-2-methyl-isothiazol-3-one, and sodium azide.

  As shown in FIGS. 2 and 6, the test element 222 includes a housing, and in this embodiment, is accommodated in the housing. The test element can be permanently located within the housing of the device, i.e. cannot be removed and inserted in the performance of the assay and can be an integral part of the assay device. Referring to FIG. 6, absorbent transfer beads are in fluid communication with the test element. In one embodiment, the test element is an absorbent test strip suitable for performing a lateral flow assay. Various test strips are suitable for the assay device. In one embodiment, the test strip consists of an absorbent matrix such as nitrocellulose and / or other suitable material. The matrix can have a sample introduction region, a reagent or label region, and a detection region. Such types of test strips are known in the art, and by reference to the present disclosure, one of ordinary skill in the art will understand the various test strips useful in the present invention. In some embodiments, a sample introduction region is present at one end of the test strip to apply the sample to the test strip. The sample introduction region is a portion of the test piece that is in fluid communication with the transfer material. Also, reagents for performing the assay or preparing the sample may be present in the sample introduction region, or may be present in a separate reagent or labeling region. These reagents can serve a variety of purposes, such as pre-treatment of the sample for optimal binding to a specific binding molecule, or improving the stability of the analyte of interest. “Adjusting” a sample means adjusting the properties of the sample to promote or improve the reaction that results in the detection of the presence of the analyte. For example, a buffer can be included to adjust the pH of the sample. If the sample contains a substance that competes for binding to the specific binding molecule used in the assay, a secondary blocking antibody can be included to bind to that substance, or specific for the analyte. If there is an enzyme in the sample that can degrade the binding molecule, one or more enzyme inhibitors can be added to the reagent region.

  The sample introduction zone is located at the upstream end 232 of the test strip. A reagent region exists and a detection region continues toward the downstream end of the test piece 234. The reagent area is a reagent for sample preparation, a reagent for analyte labeling (eg, a specific binding molecule if the assay is a sandwich format immunoassay), or a labeled assay. Product analogs (eg, where the assay is a competitive format immunoassay). In some embodiments, the reagent region comprises a labeled specific binding molecule for the analyte on the matrix in a dried form, which is allowed by the sample fluid passing along the matrix. Can be solubilized. In one embodiment, the specific binding molecule is an antibody or antibody fragment. In one embodiment, the analyte is human hemoglobin (hHb) and the labeled specific binding molecule is an antibody that binds to hHb. The antibody can be labeled by any suitable method, such as metal sols, colored latex beads, and dyes. In some embodiments, the sample introduction region and the reagent region overlap. In other embodiments, a series of reagent regions are present on the test strip.

  The detection area is an area where the presence of the analyte is detected in the test piece. In some embodiments, the detection region includes a test line, and the presence or absence of the analyte of interest on the test line is visually detected. The test line may be of any shape and need not be a single line. The test line can have a specific binding molecule for the analyte. When human hemoglobin is the analyte, a specific binding molecule on the test line binds to hHb. In this embodiment, the specific binding molecule binds to human Hb to prevent false positive results, but not to hemoglobin that may be present due to food.

Detection Method Another aspect of the invention provides a method for detecting the presence or absence of an analyte in a sample contained in a sample collection slide. In one embodiment of the method, a collection slide containing the sample is placed into the docking area of the assay device as shown in FIG. Extraction buffer 512 is added to the buffer or solvent orifice of the collection slide. The extraction buffer elutes the analyte from the sample if the analyte of interest is present. The buffer applied to the buffer orifice flows through the cover pad to the sample collection area containing the dried sample. Moisture is added back to the dried sample and a portion of the sample elutes from the collection slide through the eluent orifice. In one embodiment, the buffer is drawn through the collection pad and into the absorbent transfer material by capillary action. Excess buffer eluting from the collection slide is collected in a well surrounding the absorbent transfer material. The eluate in the transfer material flows by capillary action to the test strip introduction region and then to the downstream end of the test strip. As the eluate flows from the transfer material to the test strip, excess eluate retained in the well may be absorbed by the transfer material and carried to the test strip.

  As the eluate flows through the sample introduction region and reagent region of the test strip, it dissolves the reagents present in the introduction region or reagent region to perform the assay. In one embodiment, these reagents are dried on the test strip. As already mentioned, reagents for adjusting the eluate for optimal detection may further be included. For example, if the assay is a sandwich format immunoassay, the reagent may include a specific labeled binding molecule for the analyte, such as an antibody or antibody fragment. In one embodiment, the specific binding molecule is an anti-hHb antibody or antibody fragment labeled with gold. When an analyte is present in the sample, the labeled specific binding molecule captures the analyte to form a labeled soluble complex that is detected in the detection region. The eluate continues to flow through the test strip to a detection region that includes a test line with specific binding molecules for the analyte. For example, the specific binding molecule may be an unlabeled antibody to the analyte that binds at a different epitope than the labeled reagent. If the assay is a sandwich assay, the specific binding molecule on the test line will capture a labeled antibody-analyte complex and will display a visually detectable line that signals the presence of the analyte in the sample. Form. In this way, the inspection result appears in the result window 128 located at the top of the housing.

  In other embodiments, the assay is a competitive format immunoassay. In this embodiment, the label or reagent region of the test strip includes an analog of the labeled analyte, such as a hHb analog labeled with gold. If no analyte is present in the sample, the labeled analyte analog binds to the antibody on the test line. Thus, a positive result on the test line indicates that no analyte is present in the sample. If the analyte is present, it will compete with the labeled analog and bind to the antibody on the test line. The higher the concentration of analyte in the sample, the less analog will bind to the test line. As a result, the thinning or disappearance of the line indicates the presence of the analyte in the sample.

  Furthermore, control of the procedure can be included in the detection area. The control of the procedure can exist as a line and always appears whether or not there is an analyte in the sample. If there is no positive result from procedural control, the test is invalid.

  In other embodiments, the eluate is examined by means other than immunoassay. For example, the eluate containing the analyte can be detected using chemical means, such as guaiac testing or other chemical means.

Samples and Analyte Types A “sample” is any substance that is tested for the presence, absence, or amount of an analyte. In one embodiment, the sample is a biological sample such as a stool sample. However, any type of sample can be assayed using the method of the present invention, so long as the analyte to be detected is solubilized and included in the assay device through the collection slide. it can. Samples can be in a number of forms, such as solid, semi-solid, or highly viscous materials (such as feces, soil, tissue, blood, body fluids, or organs softened by immersion in liquid). The sample may also be an oral swab or a vaginal swab.

  A variety of analytes can be examined using the apparatus of the present invention. Examples of analytes that can be detected using the present invention include, but are not limited to, hemoglobin or other blood components, creatinine, bilirubin, nitrite, protein (unspecified), hormone (eg, human chorionic Gonadotropins, luteinizing hormones, follicle stimulating hormones, etc.), white blood cells, sugars, heavy metals or toxins, bacterial components (eg, E. coli O157: H7, Staphylococcus aureus, Salmonella, Salmonella typhi, Shigella, Clostridium perfringens, Clostridium difficile, Campylobacter Bacteria, Helicobacter pylori, Listeria monocytogenes, Vibrio parahaemolyticus, cholera, or Bacillus cereus, etc., specific proteins, sugars, or antigens), eggs and parasites, and pH and specific gravity of urine samples Physical Gender, and the like. Any analyte that can design a reliable assay can be detected. By referring to this disclosure, one of ordinary skill in the art will understand that various antigens can be detected using various assay principles applicable in the present invention.

Test Kits A further aspect of the present invention includes a kit comprising one or more collection slides of the present invention, and / or one or more assay devices of the present invention, and instructions for using them in the performance of the assay. provide. The test kit can be packaged in various formats depending on the needs of the user. In one embodiment, the instructions provided with the kit are instructions for detecting the presence of hemoglobin in the stool sample.

  In one embodiment, the kit includes three collection slides, three assay devices, three applicators, a dry mailing bag having three sealable compartments, and instructions for collecting samples. These are provided in a package. The package may be any suitable container. In various embodiments, the package may be a box, a bag, a bag, or simply a packaging material that constrains the items of the kit together.

  In other embodiments, the kit includes one or more collection slides and assay devices individually packaged in a foil bag, and further includes one or more bottles and instructions for the extraction buffer, which are packaged Provided by. In another embodiment, the kit includes three individually packaged collection slides, an extraction buffer for performing three tests, and instructions for use. In a health care facility where multiple tests are expected to be performed, the kit includes a large number of individually packaged test devices, one or two large bottles of extraction buffer, and only one piece of instructions for use. be able to.

  Further embodiments provide a kit comprising two “mini-kits”, where one mini-kit correctly collects three collection slides, three applicators, a dry mailing bag, and a sample. Includes instructions to the patient explaining the packaged together. The second mini-kit can include three test devices, three extraction buffers sufficient to perform the three tests, and instructions for use, packaged together for the physician.

Example 1-Effect of Transfer Bead Processing with Surfactant on Buffer Flow Rate This example describes the use of surfactant transfer material (Triton® X-100 (synonymous) in the manufacture of an assay device. : Octylphenol ethoxylate, polyoxyethylene, octylphenyl ether).

  Absorbent transfer material in the form of beads was treated with a solution of Tris-Casein-PVP buffer containing 0, 1, 2, 3, 4, or 5% Triton® X-100. Thereafter, the saturated transfer beads were completely dried at 55 ° C., and then each bead was inserted into the bead orifice of an assembled test device containing the test strip. A collection slide (unfilled) with a sample pad treated with 0.06 ug Triton® X-100 is engaged with the test device and 200 μl to 240 μl of buffer into each buffer orifice. added. The time until the control line appeared in the result window was measured. In all cases, the buffer passed an empty collection slide in 5 seconds. If the transfer beads did not contain Triton® X-100 (0%), it took 68 seconds for the control line to appear on the test strip. However, the time was shortened from 19 seconds to 26 seconds by setting the concentration of Triton (registered trademark) X-100 to 1% to 5%. Therefore, Triton® X-100 at a concentration of 1% to 5% greatly reduces the length of time that the sample flows.

Example 2-Effect of Surfactant Concentration of Collection Slide Cover Pad on Buffer Flow Rate This Example Treats Collection Slide Cover Pad with Surfactant to Obtain Faster Buffer Flow Rate Explain the benefits.

  All test devices contained transfer beads treated with 1.2 μg Triton® X-100. The sample collection pad of the collection slide was not processed. Cover pads were treated with 0, 0.31, 0.63, 1.25, 2.5, or 5% Triton® X-100 (20 μl). An empty collection slide was engaged with the test apparatus and 200 μl of buffer was added to each buffer orifice to create lateral flow. When the cover pad was not treated with surfactant (0% Triton® X-100), the buffer could not flow to the collection slide. As the concentration of Triton® X-100 increased, the flow rate increased. When the cover pad was treated with 0.31% Triton® X-100, the control line appeared in 20 seconds. When the concentration of Triton® X-100 was 0.63%, 1.25%, 2.5%, and 5%, control lines appeared at 17, 16, 15, and 12 seconds, respectively. However, at higher surfactant concentrations (ie, 1.25% and 5% Triton® X-100), it was found that the buffer leaked out of the sample area of the collection slide.

Experiment 3-Effect of sample cover pad and transfer beads on test sensitivity This example illustrates that the cover pad and sample collection pad have the ability to allow the passage of hemoglobin and therefore do not interfere with the sensitivity of the assay.

  Solutions containing 0, 50, 100, and 200 ng hHb per ml were prepared. Collection slides with cover pads treated with 0.53% Triton® X-100 (20 μl) with transfer beads treated with 1.2 μg Triton® X-100 Engaged with the docking area of the assay device. 200 μl of the hHb solution was applied to the buffer orifice of the sampling slide, and the strength of the test line was measured at a constant incubation time of 5 minutes. As a control, 140 μl of hHb solution was applied directly to a test strip housed in a test device without transfer beads. The strength of the test line of this control test was also measured in 5 minutes.

  It was found that the test sample and the control sample produced the same result. At a 0 ng hHb concentration per ml, both the test and control gave negative results. At 50 ng hHb per ml, both the device containing the treated pad / bead and the control device gave a weak positive signal. At 100 ng hHb per ml, both the device containing the treated pad / bead and the control device produced a moderate positive signal. At 200 ng hHb per ml, both the device containing the treated pad / bead and the control device produced a moderate positive signal. Thus, the cover pad and transfer beads do not retain hHb and have no significant effect on the sensitivity of the test.

Example 4-Use of collection slides and assay device for analysis of hBh in stool Three collection slides of the present invention are prepared by a patient. In a medical health facility, each card is placed in the docking area of the assay device of the present invention. Place the collection slide into the docking area so that the hinged side of the slide is inserted below the tongue and the elution orifice of the collection slide is in fluid communication with the absorbent transfer material of the device. Is pushed downward and fitted into a predetermined position in the docking area.

  Three drops (about 200 μl) of extraction buffer are added to the solvent orifice of the collection slide. During a short (eg, 5 minute) incubation period, the buffer is sucked through the sampling pad and absorbent transfer material into the test element of the device, where detection of analyte (hHb) occurs. The test element is a test strip having a test line with a specific binding molecule for hHb and a reagent region with a labeled antibody for hHb. After the incubation period, the detection area of the assay device is observed and confirmed to show both positive results (red line) on the control line and test line, and a positive result for hHb in the stool sample Is shown.

  The invention described herein by way of example can be practiced without any one or more components or one or more limitations not specifically disclosed herein. The expressions and phrases used are used as descriptive expressions and not as limiting expressions, and the use of such terms and phrases may include features and portions thereof illustrated and described. It is understood that the equivalents are not intended to be excluded, and that various changes can be made in the technical scope of the present invention described in the claims. Thus, although the present invention has been specifically disclosed by various embodiments and optional features, those skilled in the art can rely on modifications and variations of the concepts disclosed herein, and such modifications and Variations are considered to be within the scope of the invention as defined by the appended claims.

  The contents of the articles, patents, and patent applications mentioned or cited herein, as well as all other literature and electronically available information, are incorporated by reference in their entirety as if each individual publication And to the same extent as specifically and separately indicated, are hereby incorporated by reference. Applicants reserve the right to physically incorporate any and all materials and information from such papers, patents, patent applications, or other documents into this application.

FIG. 4 presents perspective views of various aspects of the present invention 100 including a sample collection slide 110 and an inspection device 120 that engages the collection slide. Also shown is a sample collection tool 134 for applying the sample to a collection slide. An exploded view of the device shown in FIG. 1 is presented. Shows application of sample to slide for collection. Shown is an open collection slide, with cover pad 218 and collection pad 216 shown. Shows application of sample to slide for collection. Fig. 3 shows application of sample 310 to a collection pad. Shows application of sample to slide for collection. A closed collection slide is shown. A collection slide 110 is shown engaging the docking area 126 of the inspection device. FIG. 10 illustrates application of extraction buffer 512 to solvent orifice 116 of the collecting slide after engagement. A cross-sectional view of the sampling slide 110 engaged with the inspection device 120 is presented.

Claims (30)

An apparatus for detecting an analyte in a sample,
A test element;
For receiving and engaging an external collection slide with an absorbent transfer material disposed therein and having a sample transfer orifice in fluid communication with the test element. Docking area,
A device comprising a housing including a result window for observing a test result.   The apparatus of claim 1, wherein the absorbent transfer material is a material selected from the group consisting of ultra high molecular weight polyethylene, polyethylene, polyurethane, nylon, polyester, polypropylene, polytetrafluoroethylene, and cellulose-based materials. .   The apparatus of claim 2, wherein the absorbent transfer material comprises an ultra high molecular weight polyethylene filter.   4. The device of claim 3, wherein the sample transfer orifice includes a well in the device housing and the absorbent transfer material is located in the well.   The apparatus of claim 3, wherein the absorbent transfer material comprises a surfactant.   The absorbent transfer material is polyoxyethylene (23) dodecyl ether, polyoxyethylene (9) lauryl alcohol, poly (oxyethylene-cooxypropylene) block copolymer, p-isononylphenoxy-poly (glycidol), Anhydrous sorbitol monostearate, polydimethylsiloxane methyl ethoxylate, polyethoxylate (20) oleyl alcohol, polyethoxylate (35) castor oil, polyoxyetherene (20) sorbitan monolaurate, octylphenol ethoxylate (1.2 ), Octylphenoxypolyethoxy (5) ethanol, octylphenoxypolyethoxy (9-10) ethanol, octylphenoxypolyethoxy (30) ethanol, sodium olefin (C14-C16) so Phosphonate, sodium polyoxyethylene (1) lauryl sulfate, benzalkonium chloride, ethylenediamine alkoxylate block copolymer, 2,4,7,9-tetramethyl-5-decyne-4,7-diol ethoxylate ( 10), 2,4,7,9-tetramethyl-5-goodweterdecyne-4,7-diol ethoxylate (30), amine alkylbenzene sulfonate, poly (oxyethylene-co-oxypropylene) block copolymer Telomer B monoether, sodium dioctyl sulfo-succinate, poly (vinyl methyl ether / maleic anhydride) copolymer, sodium N-oleyl-N-methyl taurate, dodecyl sulfate, sodium taurocholate, sodium bileate, N-citrt Limethylammonium bromide, N, N-dimethyldodecylamine N-oxide, 3- [3- (colamidopropyl) dimethylammonio] -1-proansulfonate, alcohol ethoxylate, n-octyl saccharose, n-dodecyl saccharose, n-dodecyl maltoside, octyl glucoside, octyl thioglucoside, n-hexyl glucoside, n-dodecyl glucoside, tris (hydroxymethyl) aminomethane buffer, phosphate buffer, borate buffer, tartrate buffer, phthalate buffer, polyvinylpyrrolidone alone Polymer, poly (vinyl methyl ether / maleic anhydride), polyethylene oxide, polyethylene glycol, polyvinyl alcohol, 1-ethenyl-2-pyrrolidinone, teleost gelatin, cross-linked polyacrylate Luric acid polymer, hydroxypropylcellulose, sodium carboxymethylcellulose, sodium polystyrene sulfate, sodium carrageenin, acrylic acid latex, hydroxyethylcellulose, bovine serum albumin, ovalbumin, casein, 5-chloro-2-methyl-isothiazole-3- 4. The apparatus of claim 3, comprising a reagent selected from the group consisting of on and sodium azide. A test element is contained within the housing;
Sample application area in fluid communication with the absorbent transfer material,
A resorbable matrix comprising a reagent region containing reagents for performing the assay, and a test line, the detection region having a detection region for visually detecting the presence or absence of an analyte in the test line. The apparatus according to 1.   8. The apparatus of claim 7, wherein the test line further comprises a specific binding molecule for the analyte immobilized on the matrix.   8. The device of claim 7, wherein the specific binding molecule on the test line binds to human hemoglobin.   The device of claim 1, wherein the analyte is human hemoglobin.   The apparatus of claim 7, wherein the reagent region comprises a labeled specific binding molecule for the analyte.   The device according to claim 8, wherein the specific binding molecule is an antibody.   The apparatus of claim 1, wherein the docking area further comprises one or more mating locks for holding the sample collection slide in position within the docking area.   The apparatus of claim 1, wherein the docking region includes one or more protrusions for securing the sample collection slide in place above the absorbent transfer pad.   The apparatus of claim 1, wherein the docking area comprises a recess in the housing that is at least partially surrounded by an elevated area of the housing. A device for collecting and transferring samples,
A first card having an inner surface and an eluent orifice;
Hinged to the first card, having an inner surface and a solvent orifice, the collection slide has an open position and a closed position, and the solvent orifice and elution when the collection slide is in the closed position An apparatus comprising: a second card aligned with a liquid orifice; and a sample collection area on the first card to which a sample is applied for collection. Sample collection area
A sample collection pad overlying the eluent orifice of the first card, and a cover pad overlying the solvent orifice located on the second card;
The sample application region is at least partially surrounded by a sealing structure on the first card;
The apparatus of claim 16, wherein the second card further comprises a sealing structure complementary to the structure on the first card.   The structure on the first card is a gasket, the structure on the second card is a groove, and when the sampling slide is in the closed position, the gasket on the first card is a groove on the second card. 18. The device of claim 17, wherein the device engages.   18. The apparatus of claim 17, wherein the cover pad and / or collection pad includes a reagent for eluting the analyte from the sample.   20. The device of claim 19, wherein the reagent is selected from the group consisting of a blocking agent, a surfactant, a wetting agent, a solubilizer, a stabilizer, a diluent, and a preservative.   The reagent is polyoxyethylene (23) dodecyl ether, polyoxyethylene (9) lauryl alcohol, poly (oxyethylene-cooxypropylene) block copolymer, p-isononylphenoxy-poly (glycidol), sorbitol monostearate Rate, polydimethylsiloxane methyl ethoxylate, polyethoxylate (20) oleyl alcohol, polyethoxylate (35) castor oil, polyoxyetherene (20) sorbitan monolaurate, octylphenol ethoxylate (1.2), octylphenoxy Polyethoxy (5) ethanol, octylphenoxy polyethoxy (9-10) ethanol, octylphenoxy polyethoxy (30) ethanol, sodium olefin (C14-C16) sulfonate, na Lithium polyoxyethylene (1) lauryl sulfate, benzalkonium chloride, ethylenediamine alkoxylate block copolymer, 2,4,7,9-tetramethyl-5-decyne-4,7-diol ethoxylate (10), 2 , 4,7,9-tetramethyl-5-good wetterdecin-4,7-diol ethoxylate (30), amine alkylbenzene sulfonate, poly (oxyethylene-co-oxypropylene) block copolymer, Telomer B mono Ether, sodium dioctylsulfo-succinate, poly (vinyl methyl ether / maleic anhydride) copolymer, sodium N-oleyl-N-methyl taurate, dodecyl sulfate, sodium taurocholate, sodium bile acid, N-citrtrimethyl Ammo Nitrobromide, N, N-dimethyldodecylamine N-oxide, 3- [3- (colamidopropyl) dimethylammonio] -1-proansulfonate, alcohol ethoxylate, n-octyl saccharose, n-dodecyl saccharose, n- Dodecyl maltoside, octyl glucoside, octyl thioglucoside, n-hexyl glucoside, n-dodecyl glucoside, tris (hydroxymethyl) aminomethane buffer, phosphate buffer, borate buffer, tartaric acid buffer, phthalic acid buffer, polyvinylpyrrolidone homopolymer , Poly (vinyl methyl ether / maleic anhydride), polyethylene oxide, polyethylene glycol, polyvinyl alcohol, 1-ethenyl-2-pyrrolidinone, teleost gelatin, cross-linked polyacrylic acid polymer Hydroxypropylcellulose, sodium carboxymethylcellulose, sodium polystyrene sulfate, sodium carrageenan, acrylic acid latex, hydroxyethylcellulose, bovine serum albumin, ovalbumin, casein, 5-chloro-2-methyl-isothiazol-3-one, and azide 20. The device according to claim 19, selected from the group consisting of sodium hydride.   The apparatus of claim 16, wherein the first card and the second card are comprised of plastic.   The apparatus of claim 16, wherein the sample is a stool sample. A method for detecting the presence or absence of an analyte in a sample contained on a sample collection slide, comprising:
A collection slide containing a sample, having a first water-resistant card having an eluent orifice and a second water-resistant card having a solvent orifice connected to the first card by a hinge and open A collection slide, further comprising a sample collection surface having a position and a closed position and existing between the solvent orifice and the eluent orifice when in the closed position;
Includes a test element contained in the housing, a docking area for receiving a sampling slide, and a result window for observing the test results, the docking area having an absorbent transfer material disposed therein for absorption Placing an agent transfer material into a docking region of an apparatus for detecting an analyte in a sample, including a sample transfer orifice in fluid communication with a test element;
Adding extraction buffer to the solvent orifice of the collection slide;
Allowing the passage of the extraction buffer to the absorbent transfer beads and test element through the sample region, and observing the test results in a result window. The test element is
Sample application area in fluid communication with the transfer bead,
25. The method of claim 24, comprising an absorbent matrix having a reagent region containing a reagent for performing the assay, and a detection region comprising a test line for detecting the presence or absence of the analyte.   26. The method of claim 25, wherein the test line comprises a specific binding molecule for the analyte.   26. The method of claim 25, wherein the test line includes a reagent for performing a chemical test.   25. The method of claim 24, wherein the analyte is human hemoglobin. A kit for collecting biological samples,
A first water-resistant card having an inner surface and an eluent orifice, a second water-resistant card hinged to the first card and having an inner surface and a solvent orifice, and a sample applied for collection A sample slide with a sample collection area on the first water-resistant card having an open position and a closed position, wherein the solvent orifice and the eluent orifice are aligned when in the closed position; Collection slides,
A housing including a test element, a docking area for engaging the sampling slide, and a result window for observing a test result, wherein the docking area has an absorbent transfer material disposed therein; An apparatus for detecting an analyte in a fluid, comprising a sample transfer orifice in which the replacement material is in fluid communication with the test element;
Sample collector,
A kit containing a collection device after collection and instructions for use, which are supplied in a package.   30. The kit of claim 29, further comprising one or more bottles comprising a buffer for performing the assay according to the instructions for use.

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