WO2006116917A2 - Dispositifs et procedes de collecte et d'analyse d'echantillons - Google Patents

Dispositifs et procedes de collecte et d'analyse d'echantillons Download PDF

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Publication number
WO2006116917A2
WO2006116917A2 PCT/CN2006/000806 CN2006000806W WO2006116917A2 WO 2006116917 A2 WO2006116917 A2 WO 2006116917A2 CN 2006000806 W CN2006000806 W CN 2006000806W WO 2006116917 A2 WO2006116917 A2 WO 2006116917A2
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WO
WIPO (PCT)
Prior art keywords
sample
collection
card
sodium
analyte
Prior art date
Application number
PCT/CN2006/000806
Other languages
English (en)
Other versions
WO2006116917A3 (fr
Inventor
Jielin Dai
Haipeng Hu
Feier Liao
Weidong Yu
Shaomin Sun
Original Assignee
Oakville Hong Kong Co., Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US11/119,528 external-priority patent/US8062901B2/en
Priority claimed from CN 200510070353 external-priority patent/CN1760672B/zh
Application filed by Oakville Hong Kong Co., Limited filed Critical Oakville Hong Kong Co., Limited
Priority to DE212006000036U priority Critical patent/DE212006000036U1/de
Priority to JP2008508056A priority patent/JP2008541009A/ja
Priority to US11/913,130 priority patent/US20090117660A1/en
Publication of WO2006116917A2 publication Critical patent/WO2006116917A2/fr
Priority to GB0721125A priority patent/GB2440470B/en
Publication of WO2006116917A3 publication Critical patent/WO2006116917A3/fr
Priority to HK08108210.9A priority patent/HK1117594A1/xx

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Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/72—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood pigments, e.g. haemoglobin, bilirubin or other porphyrins; involving occult blood

Definitions

  • the present invention is directed to devices for the collection of solid or semisolid biological samples, and their analysis for the presence of analytes.
  • the present invention provides devices, methods, and kits for collection and analysis of a biological sample.
  • the biological sample is a stool sample.
  • One aspect of the invention is a collection slide having two cards that are hingeably connected. On the inner surface of a card is a sample collection area for deposition of the biological sample.
  • the cards also contain orifices so that buffers can be passed through the cards and through the sample collection area, to elute analytes of interest from the sample contained in the cards.
  • the present invention also provides a device for detecting an analyte in a biological sample.
  • the device contains a test element, such as a test strip, having reagents for detecting the analyte.
  • the device also contains a docking area for receiving the collection slide. In the docking area is a sample transfer orifice having an absorbent transfer material, which receives buffer passed through the orifices of the collection slide, and passes the eluted fluid to the test element.
  • the present invention provides a device for detecting an analyte in a sample.
  • the device has a housing containing a test element, and a docking area on the housing for receiving and engaging a collection slide.
  • the docking has a sample transfer orifice with an absorbent transfer bead disposed therein and in fluid communication with the test element.
  • the device also has a results window for observing a test result.
  • the transfer material can be made of a variety of materials or shapes.
  • the transfer material is ultra-high molecular weight polyethylene, polyethylene, polyurethane, nylon, polyester, polypropylene, polytetrafluoroethylene, or a cellulose-based material.
  • the transfer material is an ultra-high molecular weight polyethylene filter.
  • the sample transfer orifice of the device is a well situated in the housing of the device.
  • the well is an indentation in the housing and serves to collect fluid that overflows from the absorbent transfer material.
  • the absorbent transfer material can also contain reagents for improving the transfer of analyte from the collection slide to the test element.
  • the transfer material includes a reagent selected from the group consisting of: a surfactant, a protein, a buffer, a polymer and a preservative.
  • a "surfactant” is a chemical compound that reduces the surface tension between two liquids. Surfactants can have a hydrophilic (attracted to water) group and a hydrophobic (repelled by water) group.
  • Proteins are large molecules composed of one or more chains of amino acids in a specific order and folded shape determined by the sequence of nucleotides in the gene encoding the protein.
  • a “buffer” is a solution containing either a weak acid and its salt or a weak base and its salt, and is resistant to changes in pH.
  • a “polymer” can be any of numerous natural and synthetic compounds of usually high molecular weight consisting of up to millions of repeated linked units, each a relatively light and simple molecule.
  • a “preservative” is an additive used to protect against decay, discoloration, or spoilage.
  • the transfer material contains a reagent.
  • the reagent can be any one or more of; a blocking agent, a surfactant, a wetting agent, a solubilizer, a stabilizer, a diluent and a preservative.
  • Blocking agents can be any of a number of compounds or substances that bind to an analyte or a support media, and thereby prevent binding of an analyte to the support media.
  • “Wetting agents” are usually organic based materials that modify the surface tension of liquids and help to provide a uniform coating on hard-to-wet or hydrophobic surfaces.
  • Stabilizers are compounds that prevent degradation of the tertiary structure of compounds. For example, compounds can be added to the collection slide to prevent decomposition of the Hb molecules in the sample, or of specific binding molecules in the device.
  • the transfer bead comprises a reagent selected from the group consisting of BRIJ ® 35, Chemal LA-9, Pluronic ® L64, Surfactant 1OG, Span ® 60, Silwet ® L7600, Rhodasurf ON-870, Cremohor ® EL, Tween ® 20, Tween ® 80, Surhynol ® 485, Igepal ® CA210, Triton ® X-45, Triton ® X-100, Triton ® X-305, Bio-Terge ® AS-40, Standapol ES-I, Benzalkonium Chloride, Tetronic ® 1307, Surynol ® 465, Ninate ® 411, Pluronic ® F69, Zonyl ® FSN 100, AEROSOL ® OT 100%, Geropon ® T77, sodium dodecylsulfate, sodium taurocholate, sodium
  • the test element is present within the housing and is a bibulous matrix having a sample application zone in fluid communication with the absorbent transfer material.
  • the test element has a reagent zone containing reagents for conducting an assay, and a detection zone having a test line for visually detecting the presence or absence of the analyte at the test line.
  • the test line can have a specific binding molecule for the analyte immobilized on the matrix.
  • the analyte of interest is human hemoglobin and the specific binding molecule on the test line binds to human hemoglobin.
  • the reagent zone can contain a labeled specific binding molecule for the analyte, which in one embodiment is an antibody.
  • the specific binding molecule can be present in a dried form, and can be solubilized by the passing sample fluid.
  • the test line has reagents for conducting a chemical test.
  • the docking area has one or more snap locks for holding a sample collection slide in position in the docking area.
  • the docking area can have projections for securing a sample collection slide in position above the absorbent transfer pad.
  • “snap lock” is meant one or more projections through which the collection slide fits tightly. Thus, when the collection slide is moved into place, it will “snap” into position past the “snap locks.”
  • the projections can project into the area of the docking area.
  • the docking area can also be an area into which the collection slide is inserted in a sliding motion. In either embodiment, the eluent orifice of the collection slide is brought into liquid communication with the absorbent transfer material.
  • the docking area can be present as a depression or depressed portion of the housing, which is at least partially circumscribed by a raised area of the housing. Alternatively, the docking area can be present as a raised portion of the housing.
  • the present invention provides a collection slide for collecting and transferring a sample.
  • the collection slide has a first card having an inner surface and a eluent orifice, and a second card hingeably connected to the first card and having an inner surface and a solvent orifice.
  • the collection slide has an open position and a closed position, where the solvent and eluent orifices are aligned when the collection slide is in the closed position.
  • the collection slide also has a sample collection pad on the first card, to which sample is applied for collection. In one embodiment the sample collection pad is present between the solvent and eluent orifices when the collection slide is in the closed position.
  • the first and second cards can be made of a water-resistant or water-impermeable material. In one embodiment, the first and second cards are made of plastic.
  • the sample collection area further has a collection pad overlaying the eluent orifice on the first card, with the sample application area at least partially circumscribed by a sealing structure on the first card.
  • the second card can have a cover pad overlaying the solvent orifice, where the second card also has a sealing structure, complementary to the structure on the first card.
  • the structure on the first card is a gasket, which engages the structure on the second card, which is a groove, when the collection slide is in the closed position.
  • “Sealing structures” are those which impede the movement of sample into or out of the sample collection area when engaged.
  • the first card can have the groove and the second card can have the gasket.
  • some embodiments utilize other structures, for example ridges that are generally sealed when the first and second card are in the closed position, or other structures.
  • the first card or second card contains one or more holes for receiving a projection from the second card or first card, respectively, to retain the slide in a closed position.
  • 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 or bibulous material.
  • the cover pad and/or collection pad contain reagents for eluting analyte from the sample.
  • the reagent can be one or more of surfactants, buffers, proteins, polymers and preservatives, or a blocking agent, a surfactant, a wetting agent, a solubilizer, a stabilizer, a diluent and a preservative.
  • Examples of useful reagents include BRIJ ® 35, Chemal LA-9, Pluronic ® L64, Surfactant 1OG, Span ® 60, Silwet ® L7600, Rhodasurf ON-870, Cremohor ® EL, Tween ® 20, Tween ® 80, Surhynol ® 485, Igepal ® CA210, Triton ® X-45, Triton ® X-100, Triton ® X-305, Bio-Terge ® AS-40, Standapol ES-1, Benzalkonium Chloride, Tetronic ® 1307, Surynol ® 465, Ninate ® 411, Pluronic ® F69, Zonyl ® FSN 100, AEROSOL ® OT 100%, Geropon ® T77, sodium dodecylsulfate, sodium taurocholate, sodium cholate, CTAB, LDAO, CHAPS, NP40, n
  • the present invention provides methods of detecting the presence or absence of an analyte in a sample contained in a sample collection slide.
  • the methods involve placing a collection slide containing the sample into a docking area of a device for detecting analyte in a sample.
  • the device and collection slide used in the methods are any as described herein. Additional steps of the methods involve applying an extraction buffer to the solvent orifice of the collection slide, allowing the extraction buffer to pass through the sample area and into the absorbent transfer bead and test element, and observing a test result in the results window.
  • kits for collecting and analyzing a biological sample contain at least one collection slide as described herein, and a device for detecting an analyte in a fluid as described herein, provided in a package.
  • the kits can contain one or more sample collector(s) as described herein, an envelope for containing a loaded collection device, and instructions for use, provided in a package.
  • the kits can contain the sample collection slide, the device, and one or more of any of the additional components described. Any of the kits can also contain one or more bottles containing buffers for conducing an assay according to the instructions for use.
  • the instructions for use are instructions for detecting the presence of hemoglobin in a feces sample.
  • the present invention provides methods of collecting a sample.
  • the methods involve contacting a sample applicator loaded with sample with the sample collection pad of a collection slide as described herein, and placing the collection slide in the closed position.
  • the methods also involve placing the closed collection slide containing the collected sample into an envelope or desiccation chamber.
  • the placing of the collection slide into the closed position can include the step of pressing the first card and second card together to engage the one or more projections into one or more holes and locking the collection slide in the closed position.
  • the placing the collection slide into the closed position can cause excess sample to be excluded from the sample collection pad.
  • the sample collection applicator is a tool having a portion for collecting sample, and the portion for collecting sample has a plurality of holes for the drainage of a fluid portion of the sample.
  • the portion for collecting sample is primarily flat.
  • the present invention includes a variety of other useful aspects, which are detailed herein. These aspects of the invention can be achieved by using the articles of manufacture and compositions of matter described herein. With reference to the present disclosure, it will be further recognized that various aspects of the present invention can be combined to make desirable embodiments of the invention. In addition, a variety of other aspects and embodiments of the present invention are described herein.
  • Figure 1 provides a perspective view of the different aspects of the present invention 100, which includes a sample collection slide 110 and a test device 120 that engages the collection slide. Also shown is the sample collector 134 for applying the sample to the collection slide.
  • Figure 2 provides and exploded view of the devices shown in Figure 1.
  • Figures 3 A - 3 C illustrate application of a sample to the collection slide.
  • Figure 3 A illustrates an opened collection slide, showing a cover pad 218 and a collection pad 216.
  • Figure 3B illustrates application of the sample 310 to the collection pad.
  • Figure 3C illustrates a closed collection slide.
  • Figure 4 illustrates a collection slide 110 engaging the docking area 126 of a test device.
  • Figure 5 illustrates application of extraction buffer 512 to the solvent orifice 116 of the engaged collection slide.
  • Figure 6 provides a cross-sectional view of the collection slide 110 engaged in a test device 120.
  • the present invention provides collection slides for collecting a solid or semisolid sample.
  • the sample is a biological sample, such as a stool sample.
  • the present invention also provides devices for detecting the presence of analytes in the sample, and methods for collecting the sample.
  • the collection slide 110 has a first card 114 and a second card 112.
  • the first and second cards may be made of any appropriate material.
  • the cards can be made of a resilient, water resistant or water-impermeable material, such as plastic, coated cardboard, metal or glass.
  • the cards are hingeably connected to each other, for example by a hinge 224 ( Figure 2).
  • hinge 224 Figure 2
  • hingeably connected is meant that the two cards are connected to each other at their first ends and have free ends movable towards and away from each other by movement about the hinge. A wide variety of hinge connections may be advantageously used.
  • the collection slide is manufactured of injection molded plastic and the two cards are connected by a living hinge, as depicted in Figure 2.
  • the hinge can be one or more flaps of material that bind the two cards together and allow for one card to be folded onto the other card.
  • the cards are present as separate cards that can be secured together, for example by a locking mechanism.
  • the second card has a buffer or solvent orifice 116, through which an extraction buffer 510, 512 can be applied to a collected sample ( Figures 1 and 5).
  • the collection slide has an open position and a closed position (compare Figures 1 and 2).
  • the first card has an eluent orifice 210 and the second card has a solvent orifice 116.
  • the buffer and eluent orifices are positioned on the cards so that when the collection slide is in the closed position, the two orifices are in alignment.
  • the orifices being "aligned” or “in alignment” is meant that a liquid applied to the solvent orifice in the second (or top) card in sufficient quantity will pass through the sample collection area and through the eluent orifice.
  • a cover pad 218 is present on the inner surface of the second card and overlaying the buffer orifice 116.
  • the cover pad and sample collection pad can be made of any suitable material that retains sample and allows the passage of fluid.
  • materials suitable for the cover pad and/or sample collection pad are polyester mesh, fibrous or bibulous materials, paper or paper-based materials, synthetic fabrics, meshes and wools, coated or supported papers, polyesters, nylon membranes, nitrocelluose, glass wool, treated paper, absorbent paper, or a material made of a cellulose base.
  • the cover pad 218 is circumscribed by a gasket 220. With reference to the present disclosure the person of ordinary skill in the art will realize many other materials suitable for the cover pad and/or sample application pad.
  • an eluent orifice 210 which is overlaid with a sample collection pad 216.
  • the sample collection pad 216 can be made of any suitable material that retains sample and allows for the passage of fluid.
  • the sample collection pad 216 is made of the same types of materials as the cover pad.
  • the sample collection pad can be circumscribed by ridge 214 and groove 212, or by a series of ridges and grooves.
  • the cover pad and the collection pad can be made of any suitable material that retains sample and allows for the passage of fluid. Examples are provided above with respect to material for the cover pad.
  • the material should also have sufficient resiliency to withstand the mechanical pressure of the sample application. Preferably, the material does not deteriorate or tear when wet.
  • the collection slide of the present invention limits the amount of sample that can be applied to the slide while requiring no direct sample manipulation by the technician conducting the test.
  • the amount of sample collected is limited to the sample collection area, since the cover pad and sample collection pad are circumscribed by the sealing structures (e.g., a gasket and groove) when the slide is in the closed position.
  • the sealing structures e.g., a gasket and groove
  • the sealing structures can also be structures other than a gasket, ridge, and groove.
  • the structures can be a pressure sensitive adhesive or a wax bead (or beads) present on or around the sample collection pad and/or cover pad, which seal the sample collection pad when the two cards are closed and pressed together.
  • the "seal" does not have to be a tight seal, just that it generally impedes the passage of sample into or out of the sample collection area when the collection slide is in the closed position.
  • the cover pad and/or collection pad can be treated with reagents that improve the flow of aqueous liquids through them. Additionally, these treatments also improve the elution of the analyte of interest from the dried sample within the sample area.
  • the pads are treated with surfactants to inhibit proteins from sticking to the pads and to promote protein solubilization.
  • surfactants A wide variety of commonly used anionic and non- ionic surfactants may be advantageously used in various concentrations. Some cationic and amphoteric surfactants may also find use in the present invention.
  • surfactants that may be used to treat the pads include, but are not limited to, the polyoxyethylene fatty ethers derived from lauryl, cetyl, stearyl and oleyl alcohols (e.g., the BRIJ ® (ICI US, Inc.) series of surfactants).
  • octyl phenol ethoxylate surfactants e.g., polyethyrene glycol mono-p-iso-octylphenyl ether and other Triton ® (Rohm & Haas, Philadelphia, PA) series surfactants
  • polyoxyethylene derivatives of sorbitan esters e.g., the Tween ® (ICI Americas, Inc.) series of surfactants
  • block copolymers based on ethylene oxide and propylene oxide and represented by HO(C 2 H 4 O) 3 (C 3 H 6 O) 13 (C 2 H 4 O) 3 H .e.g., the Pluronic ® (BASF) series of surfactants.
  • a surfactant can be conveniently chosen using known surfactant selection techniques, such as by using a commercially available surfactant tool kit, for example, the Reagent Developer's Surfactant Took Kit (Pragmatics, Inc., Elkhart, Indiana), or a similar kit. These kits provide a convenient method of testing a large number of surfactants on a specific application, in order to optimize protein extraction and flow- through.
  • a commercially available surfactant tool kit for example, the Reagent Developer's Surfactant Took Kit (Pragmatics, Inc., Elkhart, Indiana), or a similar kit.
  • the pads may be treated with a buffer containing a component that improves analyte stability.
  • Buffers can also condition the sample to promote optimal binding between the analyte and the specific binding reagents (e.g., antibodies or antibody fragments), which can be utilized in the assay. This can be performed, for example, by adjusting the pH of the analyte. Buffers having these useful qualities 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 a target analyte (e.g., human hemoglobin) and does not substantially bind to any other molecule present in the sample.
  • a specific binding molecule can also bind to a molecule that correlates with or indicates the presence of an analyte of interest in a sample.
  • substantial binding is meant that binding occurs to an extent that will affect the result of an assay performed with the specific binding molecules, i.e., a less optimal or less accurate result will be obtained.
  • a small amount of non-specific binding that may occur and that does not change the result of the assay is not considered substantial binding.
  • the specific binding molecule can be an antibody or an antibody fragment (e.g., the Fab region of an antibody), an antigen, a receptor or fragment of a receptor that binds a ligand, or a member of a biotin-streptavidin pair or other type of binding pair.
  • the cover pad and/or sample application pad can also be treated with one or more polymers, which can also have the property of improving analyte stability and elution.
  • Polymers sometimes used in protein purification can be useful for this purpose.
  • useful polymers include, but are not limited to, polyvinylpyrrolidone (PVP), poly(methylvinylether-co-maleic anhydride, polyethylene oxide (PEO), polyelthylene glycol (PEG), copolymers of methyl vinyl ether and maleic anhydride (e.g., poly(methylvinylether- co-maleic anhydride), polyvinylalcohol (PVA), vinylpyrrolidone/vinylacetate, bony fish gelatin (from fish of the class Osteichthyes), crosslinked polyacrylic acid polymer, hydroxypropylcellulose (HPC), sodium carboxymethylcelluose (CMC), sodium polystyrenesulfonate, sodium carageenin, acrylic latex, and hydroxy
  • the pads may also be treated with a nonspecific protein, which functions as a blocking agent.
  • a nonspecific protein which functions as a blocking agent. Any protein may be used for this purpose including, but are not limited to, bovine serum albumin, egg white albumin, and casein.
  • the cover pad and sample application pad can also be treated with a preservative to increase the shelf-life of the collection slide.
  • a "preservative" is a naturally or synthetically produced chemical added to inhibit microbial growth or undesirable chemical changes. Any preservative can be used that provides the preserving effect and does not interfere with the assay. Examples of useful preservatives include, but are not limited to, 5- chloro-2-methyl-isothiazol-3-one (e.g. ProClin ® 300 (Supelco, Inc., Bellefonte, PA) and sodium azide. With reference to the present disclosure the person of ordinary skill will realize many other preservatives that will find use in the present invention.
  • the cover pad and collection pad form the top and bottom walls of the sample collection area, and serve to eliminate excess sample from the sample collection area.
  • the structures on the cards are a gasket, ridge, or groove, they can also be situated on the opposite cards as those described above.
  • one of the cards of the collection slide is provided with structures for securing the first and second cards in a closed position.
  • short pins 316 Figure 3B
  • the opposite card is provided with holes 318 that mate with the pins.
  • this action may advantageously cause a snapping noise, alerting the patient that the collection slide has been properly closed.
  • Other methods of securing the collection slide in a closed position can also be incorporated into the slide.
  • a clip that fits over the outside of the two cards and holds them together could be used in one embodiment, or snaps present on the inner surfaces of the two cards can be used in another embodiment.
  • snaps present on the inner surfaces of the two cards can be used in another embodiment.
  • the present invention also provides a sample collector 134 ( Figure 1).
  • the sample collector has a handle 314 ( Figure 3) and a spatula 312 for moving the sample.
  • the spatula is perforated with a plurality of holes, which reduces the liquid content of the sample, and also serves to reduce application of excess sample to the sample collection pad.
  • the spatula portion of the device is perforated with 4, 5, 6, 7, 8, 9, 10, 11, 12, or more holes.
  • the spatula portion of the collector can be generally flat, or can have a curved (spoon-like) shape. This device can be made of any suitable material (e.g., plastic).
  • the spatula portion of the device is made of a soft plastic, and the handle is made of a harder plastic. This will enable the spatula to bend when sample is applied to the sample collection pad and lay on the pad. The perforations in the spatula portion will also act as an aid in applying an even sample to the pad.
  • Another aspect of the present invention is methods of collecting a sample.
  • the sample is a stool sample.
  • the method of sample collection and operation of the collection slide and assay device is illustrated in Figures 3A - 3C.
  • FIG. 3 A One embodiment of the methods is illustrated in Figure 3 A.
  • the patient opens the collection slide to expose the inner surfaces of the first and second slides, revealing 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 ( Figure 3C).
  • the present collection slide eliminates excess sample by providing a sample collection area, with a design such that only sample in the sample collection area will be incorporated into the assay.
  • a structure engages a structure second card, forming a wall that circumscribes the sample collection area.
  • the structure on one card is a gasket
  • the structure on the opposite card is a groove and a ridge.
  • the solvent or buffer orifice, the sample area, and the eluent orifice are all vertically aligned.
  • the buffer dilutes the sample and conditions it for optimal binding of analyte by the specific binding reagents on the test element.
  • the liquefied sample is then passed into the absorbent transfer bead of the assay device.
  • the methods can incorporate the step of drying the sample. This step can involve leaving the collection card exposed to air for a certain period of time to allow it to air dry, or drying the sample in an oven at 45 °C.
  • the step can also involve placing the closed collection slide into a container containing desiccant.
  • the container can be a sealable pouch (e.g., a mailing pouch). After drying (or placing the collection slide in a sealable pouch containing a desiccant), the collection slide can be presented to a health care facility for analysis.
  • FIG. 1 Another aspect of the present invention is an assay device 120 for analyzing a sample in the collection slide for the presence or absence of an analyte of interest (see Figures 1 and 2).
  • the assay device has a housing consisting of a top portion 122 and a bottom portion 124, which engage one another and lock together.
  • the housing may be constructed of any suitable material such as, for example, plastics, pressed hardboard, metals, ceramics, polymers (e.g., polycarbonate, polypropylene, cycloolefins), and other materials.
  • the housing is made of molded plastic.
  • top and bottom portions can engage one another by any convenient means, such as parts that snap together, glue, micro-welding, and other means.
  • the top portion has a series of pins on the inner surface (not shown) which snap-fit snuggly into a corresponding series of raised rings 228 on the inner surface 230 of the bottom portion, thereby securing the top and bottom portions of the assay device in a locked position.
  • a docking area 126 for receiving and engaging a collection slide is located on the assay device.
  • the collection slide may be "loaded” meaning that it contains a sample to be analyzed.
  • the docking area may be of any shape, and can mate with a portion of the collection slide carrying the sample collection area.
  • the docking area can receive and engage an external collection slide.
  • An external collection slide is one that can be loaded separated from the assay device, and is not physically connected to the device at the time of sample loading.
  • the docking area can also receive the collection slide in reversible fashion, meaning that the collection slide can be removed from the device after buffers are applied and sample eluted from the collection slide.
  • the collection slide is snapped into the docking area by fitting the hinged edge of the collection slide under a tang 410.
  • the collection slide is then pressed down onto the docking area and snapped into a locked position under one or more projections 412.
  • the projections hold the collection slide flush with the docking area.
  • the docking area is slided into the assay device.
  • the docking area can have a part that fits over the collection slide to hold it 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 buffer, and buffer applied to the buffer orifice passes through the sample collection pad and into the absorbent transfer material.
  • the docking area is configures to receive the collection slide against an exterior surface of the assay device, so that the sample collection area and absorbent transfer member are brought into liquid communication.
  • the docking area can have projections for holding the collection slide securing in the test position.
  • the docking area can receive the collection slide into the interior of the device.
  • sample transfer orifice is the only orifice in the assay device for receiving sample or assay fluids, and the sample and assay fluids both the device through the sample transfer orifice.
  • assay fluids refers to buffers or other regents utilized during the assay.
  • sample transfer orifice is the sole orifice for receiving sample and fluids into the device.
  • the docking area contains an indentation or well 130 having a transfer material 132 disposed therein.
  • the absorbent transfer material can take any form, for example, a bead, cube, cylinder, oval, or any shape, and can be situated inside the well.
  • the transfer material protrudes through the top portion of the housing, through an orifice 226 to he generally flush with or slightly protruding through the plane of the docking area.
  • the absorbent transfer material is an absorbent transfer bead.
  • the buffer orifice, cover pad, sample collection pad, eluent orifice, and absorbent transfer bead are all generally in vertical alignment with each other.
  • the absorbent transfer bead projects into or through the plane of the docking area, so that the absorbent transfer bead and the outer surface of the sample collection pad are placed into fluid communication through the eluent orifice.
  • fluid communication is meant that fluid passing through the sample collection area and through the sample collection pad is passed into the absorbent transfer material.
  • the sample collection pad and absorbent transfer material may make direct physical contact, or be slightly apart from one another, but are retained in fluid communication.
  • the absorbent transfer material can be constructed of a variety of useful absorbent materials.
  • the material should allow the transport of liquid from the collection slide to the test element of the assay device without changing the sample in a manner that interferes with the assay result.
  • materials suitable for the absorbent transfer material include, but are not limited to, filter paper or other paper-based filter materials, nylon mesh filters, cellulose filters (or filters made of a cellulose-based material), polyester filters, and glass wool filters.
  • the absorbent transfer bead is made of ultra-high molecular weight polyethylene (UHMWPE), polyethylene, polyurethane, nylon, polyester, polypropylene, or polytetrafluoroethylene.
  • the transfer material is a filter made of ultra-high molecular weight polyethylene filter.
  • the absorbent transfer material is treated with reagents that improve the transfer of analyte from the collection slide to a test element of the device.
  • the transfer material can be treated with any of the reagents described herein with respect to treatment of the cover pad and sample collection pad of the collection slide.
  • a test element 222 is provided with the housing, and in this embodiment is contained within the housing.
  • the test element can be permanently situated within the housing of the device, meaning that it is not removable or insertable in conducting the assay, but is an integral part of the assay device.
  • the absorbent transfer bead is in fluid communication with the test element.
  • the test element is a bibulous test strip suitable for performing a lateral flow assay.
  • a variety of test strips are suitable for use in the assay device.
  • the test strips consist of a bibulous matrix, for example nitrocellulose, and/or other suitable materials.
  • the matrix can have a sample loading zone, a reagent or label zone, and a detection zone.
  • a sample loading zone is present at one end of the test strip for the application of sample to the test strip.
  • the sample loading zone is the portion of the test strip in liquid communication with the transfer material.
  • Reagents for conducting the assay or conditioning the sample can also be present at the sample loading zone, or they can be present in a separate reagent or label zone. These reagents can serve a variety of purposes, for example preparing the sample for optimal binding with a specific binding molecule, or improving the stability of an analyte of interest.
  • conditioning a sample is meant adjusting the characteristics of the sample to promote or improve the reaction that detects the presence of the analyte.
  • buffers may be included to adjust the pH of the sample.
  • a secondary blocking antibody can be included to bind the substance, or if enzymes that would degrade the specific binding molecules for the analyte are present in the sample, one or more enzyme inhibitors can be added to the reagent zone.
  • the sample loading zone is present at the upstream end 232 of the test strip.
  • the reagent zone can include reagents for conditioning the sample, reagents for labeling the analyte (e.g., specific binding molecules if the assay is a sandwich format immunoassay) or labeled analyte analogs (e.g., if the assay is a competitive format immunoassay).
  • the reagent zone contains a labeled specific binding molecule for the analyte present on the matrix in a dried form, and which can be solubilized by sample fluid as it passes along the matrix.
  • the specific binding molecule is an antibody or fragment thereof.
  • the analyte is human hemoglobin (hHb)
  • the labeled specific binding molecule is an antibody that binds hHb.
  • the antibody can be labeled by any suitable methods, for example, a metal sol, colored latex beads, and dyes.
  • the sample loading zone and the reagent zone over- lap. In other embodiments there are present a series of reagent zones located on the test strip.
  • the detection zone is the area of the test strip where the presence of the analyte is detected.
  • the detection zone contains a test line for visually detecting the presence or absence of the analyte of interest at the test line.
  • the test line can be of any shape, and need not be only a line.
  • the test line can have a specific binding molecule for the analyte.
  • human hemoglobin is the analyte of interest
  • the specific binding molecule on the test line binds to hHb.
  • the specific binding molecule binds to human Hb, and does not bind to hemoglobin that might be present from the diet, in order to avoid false positive results.
  • Another aspect of the present invention provides methods of detecting the presence or absence of an analyte in a sample contained in a sample collection slide.
  • a collection slide containing the sample is placed into the docking area of an assay device, as shown in Figure 4.
  • Extraction buffer 512 is applied to the buffer or solvent orifice of the collection slide.
  • the extraction buffer elutes the analyte of interest from the sample, if the analyte is present.
  • Buffer applied to the buffer orifice flows through the cover pad and into the sample collection area containing the dried sample.
  • the dried sample is rehydrated and a portion of the sample elutes out of the collection slide, through the eluent orifice.
  • the buffer is pulled through the collection pad and into the absorbent transfer material by capillary action. Excess buffer eluted from the collection slide is collected in the well surrounding the absorbent transfer material. Eluate within the transfer material flows by capillary action into the application zone of the test strip, and then to the downstream end of the test strip. As the eluate flows from the transfer material into the test strip, excess eluate held in the well may be absorbed and transferred to the test strip, by the transfer material.
  • the eluate flows through the sample loading zone and reagent zone of the test strip, it dissolves reagents for conducting the assay present in the loading zone or reagent zone. In one embodiment these reagents are dried on the test strip. Reagents can also be included that condition the eluate for optimal detection, as described above.
  • immunoassay reagents may include specific labeled binding molecules for the analyte, such as an antibody or fragment thereof. In one embodiment the specific binding molecule is a gold-labeled anti-hHb antibody or antibody fragment.
  • the labeled specific binding molecule would capture the analyte and form a labeled, soluble complex, which is detected in the detection zone.
  • the eluate continues to flow through the test strip to the detection zone, which contains a test line having specific binding molecules for the analyte.
  • the specific binding molecule can be an unlabeled antibody against the analyte, which binds at an epitope different from that of the labeling reagent.
  • the assay is a sandwich assay, the specific binding molecule in the test line captures the labeled antibody-analyte complex, and forms a visually detectable line indicating that the analyte is present in the sample. The test result therefore appears in the results window 128 located in the top portion of the housing.
  • the assay is a competitive format immunoassay.
  • the label zone or reagent zone of the test strip contains a labeled analog of the analyte, such as a gold-labeled hHb analog. If no analyte is present in the sample, the labeled analyte analog binds the antibody on the test line. Therefore a positive result on the test line indicates that no analyte is present in the sample. When analyte is present, it competes with the labeled analog to bind the antibody on the test line. As the concentration of analyte in the sample increases, the amount of analog that binds to the test line decreases. Therefore, a lighter line or no line indicates the presence of analyte in the sample.
  • a procedural control can also be included in the detection zone.
  • the procedural control can be present as a line, and will always appear whether or not analyte is present in the sample. Absence of a positive result from the procedural control indicates an invalid assay.
  • the eluate is tested by means other than an immunoassay.
  • the analyte-containing eluate could be detecting using a chemical means, such as a Guaiac test or other chemical means.
  • sample is any material to be tested for the presence, absence, or quantity of an analyte.
  • the sample is a biological sample, such as a stool sample.
  • any type of sample can be assayed using the present invention, as long as it contains an analyte to be detected that can be solubilized and can be passed through the collection slide and into the assay device.
  • the sample can be in many forms, such as solid, semi-solid or highly viscous materials, such as stool, soils, tissues, blood, bodily fluids, or macerated organs.
  • the sample may also be an oral or vaginal swab.
  • a variety of analytes may be tested for using the present device.
  • hormones e.g. human chorionic gonadotropin, luteinizing hormone, follicle stimulating hormone, etc.
  • leukocytes e.g. human chorionic gonadotropin, luteinizing hormone, follicle stimulating hormone, etc.
  • leukocytes e.g. human chorionic gonado
  • the test kits can be packaged in a variety of formats, depending upon the needs of the user.
  • the instructions provided with the kit are instructions for detecting the presence of hemoglobin in a stool sample.
  • the kit contains three collection slides, three assay devices, three applicators, a desiccation mailing pouch having three sealable compartments, and instructions for collecting a sample, provided in a package.
  • the package can be any suitable container.
  • the package can be a box, a pouch, a bag, or can be simply a wrapping binding the items of the kit together.
  • kits contain one or more collection slides and assay devices individually packaged in foil pouches, and one or more bottles of extraction buffer, and instructions, provided in a package.
  • the kits contain three individually wrapped collection slides, extraction buffer for performing three tests, and instructions for use.
  • the kit can contain many individually wrapped test devices, one or two large bottles of extraction buffer, and a single copy of the instructions.
  • a further embodiment provides a kit containing two "mini-kits," wherein one mini-kit contains packaged together three collection slides, three applicators, a desiccant mail pouch and instructions for the patient explaining how to correctly collect the samples. The second mini-kit would contain, packaged together for the doctor, three test devices, extraction buffer sufficient to perform three tests and instructions for use.
  • This example illustrates the benefit of treating the absorbent transfer material with surfactant (Triton ® X-100 (synonyms: octyl phenol ethoxylate, polyoxyethylene, Octyl phenyl ether) in manufacturing the assay device.
  • surfactant Triton ® X-100 (synonyms: octyl phenol ethoxylate, polyoxyethylene, Octyl phenyl ether)
  • Triton ® X-100 When the transfer bead contained no (0%) Triton ® X-100, it took 68 seconds for the control line to appear on the test strips. However, a concentration of 1-5% of Triton ® X-100 reduced the time to 19-26 seconds. Therefore, a concentration of 1- 5% Triton ® X-100 reduces the length of sample flow time substantially.
  • This example illustrates the benefit of treating the collection slide cover pad with surfactant to obtain a faster flow rate of the buffer.
  • All test devices contained transfer beads treated with 1.2 ⁇ g of Triton ® X- 100.
  • the sample collection pads of the collection slides were untreated.
  • the cover pads were treated with 20 ⁇ l of 0, 0.31, 0.63, 1.25, 2.5 or 5% Triton ® X-100.
  • the empty collection slides were engaged in the test devices and 200 ⁇ l of buffer was added to each buffer orifice, to trigger the lateral flow. Buffer was unable to flow into the collection slide when the cover pad was not treated with a surfactant (0% Triton ® X-IOO).
  • a surfactant 0% Triton ® X-IOO
  • Triton ® X-100 concentrations 0.63%, 1.25%, 2.5% and 5%, the control line appeared at 17, 16, 15 and 12 seconds, respectively. However, it was found that at the higher surfactant concentrations (i.e. 1.25% and 5% Triton ® X-100) the buffer leaked out of the sample area of the collection slide.
  • This example illustrates the ability of the cover pad and sample collection pad to allow the passage of hemoglobin, and therefore not interfere with assay sensitivity.
  • Solutions containing 0, 50, 100 and 200 ng hHb/ml were prepared. Collection slides having cover pads treated with 20 ⁇ l of 0.53% Triton ® X-100 were engaged in the docking area of assay devices of the invention having transfer beads treated with 1.2 ⁇ g Triton ® X-100. 200 ⁇ l of the hHb solutions was applied to the buffer orifices of the collection slides, followed by measurement of the test line intensity at 5 minutes of incubation time. As a control, 140 ⁇ l of the hHb solution was applied directly to test strips housed in test devices having no transfer beads. The intensity of the test lines of the control tests was also measured at 5 minutes.
  • test samples and the control samples were found to produce the same results. At a concentration of 0 ng hHb/ml, both the test and control produced negative results. At 50 ng hHB/ml both the devices containing the treated pad/bead and the control device produced a low positive signal. At 100 ng hHb/ml both the devices containing the treated pad/bead and the control device produced a medium positive signal. And at 200 ng hHb/ml both the devices containing the treated pad/bead and the control device produced a medium positive signal. Thus, the cover pad and transfer bead do not retain hHb and have no significant effect on the sensitivity of the test.
  • each card is placed into the docking area of an assay device of the invention.
  • the hinged side of the slide is inserted under the tang, and the slide pressed downward and snapped into place in the docking area, so that the eluent orifice of the collection slide is in fluid communication with the absorbent transfer material of the device.
  • Three drops (about 200 ⁇ l) of extraction buffer are applied to the solvent orifice of the collection slide.
  • the buffer is drawn through the sample collection pad and through the absorbent transfer material, and into the test element of the device, where the detection of the analyte (hHb) occurs.
  • the test element is a test strip having at test line with specific binding molecules for hHb, and a reagent zone with labeled antibodies for hHb.
  • the detection zone of the assay device is observed and found to exhibit both a control line, and a positive result (red line) at the test line, indicating a positive result for hHb in the stool sample.

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Abstract

L'invention concerne des dispositifs, des procédés, et des kits de collecte d'un échantillon solide ou semi-solide et de son analyse afin de détecter la présence, l'absence, ou la quantité d'une substance à analyser. L'invention concerne un recueil comprenant une première et une seconde carte. La première carte présente une zone de collecte d'échantillon. Les deux cartes présentent des orifices permettant le passage de liquide à travers la zone de collecte d'échantillon, et les cartes sont connectées par articulation l'une à l'autre. L'invention concerne également un dispositif d'essai présentant un boîtier doté d'un élément d'essai, une fenêtre de résultats, et une zone de connexion permettant de recevoir et d'entrer en contact avec le cliché de collecte. Dans un mode de réalisation, le cliché de collecte et le dispositif peuvent être utilisés pour détecter la présence d'hémoglobine humaine dans un échantillon. L'invention concerne de nombreux autres modes de réalisation.
PCT/CN2006/000806 2005-04-30 2006-04-26 Dispositifs et procedes de collecte et d'analyse d'echantillons WO2006116917A2 (fr)

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DE212006000036U DE212006000036U1 (de) 2005-04-30 2006-04-26 Vorrichtungen zum Probensammeln und zur Analyse
JP2008508056A JP2008541009A (ja) 2005-04-30 2006-04-26 サンプルの採取および分析のための装置および方法
US11/913,130 US20090117660A1 (en) 2005-04-30 2006-04-26 Devices and methods for sample collection and analysis
GB0721125A GB2440470B (en) 2005-04-30 2007-10-29 Devices and methods for sample collection and analysis
HK08108210.9A HK1117594A1 (en) 2005-04-30 2008-07-24 Devices and methods for sample collection and analysis

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US11/119,528 2005-04-30
US11/119,528 US8062901B2 (en) 2005-04-30 2005-04-30 Devices and methods for sample collection and analysis
CN200510070353.X 2005-04-30
CN 200510070353 CN1760672B (zh) 2004-10-12 2005-04-30 样本检测装置和样本检测方法

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EP2317319A1 (fr) * 2008-06-30 2011-05-04 Sekisui Medical Co., Ltd. Phase solide poreuse pour essai de liaison, et procédé d'essai de liaison l'utilisant
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WO2007049009A1 (fr) * 2005-10-25 2007-05-03 Inverness Medical Switzerland Gmbh Procédé et équipement pour détecter une substance à analyser dans un échantillon
EP2317319A1 (fr) * 2008-06-30 2011-05-04 Sekisui Medical Co., Ltd. Phase solide poreuse pour essai de liaison, et procédé d'essai de liaison l'utilisant
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CN116643044A (zh) * 2023-06-15 2023-08-25 广州贝思奇诊断试剂有限公司 一种基于胶体金法检测尿液中hiv-1和hiv-2抗体的试剂盒及其制备方法、应用
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DE212006000036U1 (de) 2008-02-21
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HK1117594A1 (en) 2009-01-16
GB0721125D0 (en) 2007-12-05
WO2006116917A3 (fr) 2008-02-14

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