WO1992021977A1 - Assay device - Google Patents
Assay device Download PDFInfo
- Publication number
- WO1992021977A1 WO1992021977A1 PCT/US1992/004425 US9204425W WO9221977A1 WO 1992021977 A1 WO1992021977 A1 WO 1992021977A1 US 9204425 W US9204425 W US 9204425W WO 9221977 A1 WO9221977 A1 WO 9221977A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- analyte
- chromatographic
- sample
- chromatographic medium
- specific binding
- Prior art date
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Classifications
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
- B01L3/5055—Hinged, e.g. opposable surfaces
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
- B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
- B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
- B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/90—Plate chromatography, e.g. thin layer or paper chromatography
- G01N30/91—Application of the sample
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- 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
- G01N33/5302—Apparatus specially adapted for immunological test procedures
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- 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
- G01N33/54387—Immunochromatographic test strips
- G01N33/54388—Immunochromatographic test strips based on lateral flow
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- 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
- G01N33/558—Immunoassay; Biospecific binding assay; Materials therefor using diffusion or migration of antigen or antibody
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2300/00—Additional constructional details
- B01L2300/08—Geometry, shape and general structure
- B01L2300/0809—Geometry, shape and general structure rectangular shaped
- B01L2300/0825—Test strips
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
- B01L2400/00—Moving or stopping fluids
- B01L2400/04—Moving fluids with specific forces or mechanical means
- B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
- B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
- G01N30/02—Column chromatography
- G01N30/26—Conditioning of the fluid carrier; Flow patterns
- G01N30/28—Control of physical parameters of the fluid carrier
- G01N30/30—Control of physical parameters of the fluid carrier of temperature
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/805—Test papers
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/81—Packaged device or kit
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S435/00—Chemistry: molecular biology and microbiology
- Y10S435/97—Test strip or test slide
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S436/00—Chemistry: analytical and immunological testing
- Y10S436/807—Apparatus included in process claim, e.g. physical support structures
- Y10S436/81—Tube, bottle, or dipstick
Definitions
- antibodies particularly antibodies induced as a result of infection with pathogens, such as antibody to the bacterium Helicobacter pylori and to human immunodeficiency virus (HIV) ;
- hemoglobin 25 frequently assayed in determinations of fecal occult blood, an early indicator of gastrointestinal disorders such as colon cancer;
- drugs both therapeutic drugs, such as antibiotics, tranquilizers and anticonvulsants, and illegal drugs of abuse, such as cocaine, heroin, and marijuana; and
- immunoassays which depend on the specific interaction between an antigen or hapten and a corresponding antibody.
- the use of immunoassays as a means of testing for the presence and/or amount of clinically important molecules has been known for some time.
- J.M. Singer reported the use of an immune-based latex agglutination test for detecting a factor associated with rheumatoid arthritis (Singer et al., Am. J. Med. 22:888-892 (1956)).
- this technique uses a disclosing reagent or particle that has been linked to an antibody to the molecule to be assayed, forming a conjugate. This conjugate is then mixed with a specimen and, if the molecule to be assayed is present in the specimen, the disclosing reagent-linked antibodies bind to the molecule to be assayed, thereby giving an indication that the molecule to be assayed is present.
- the disclosing reagent or particle can be identifiable by color, magnetic properties, radioactivity, specific reactivity with another molecule, or another physical or chemical property. The specific reactions that are employed vary with the nature of the molecule being assayed and the sample to be tested.
- Immunochromatographic assays fall into two principal categories: “sandwich” and “competitive,” according to the nature of the antigen-antibody complex to be detected and the sequence of reactions required to produce that complex.
- the sandwich immunochromatographic procedures call for mixing the sample that may contain the analyte to be assayed with antibodies to the analyte. These antibodies are mobile and typically are linked to a label or a disclosing reagent, such as dyed latex, a colloidal metal sol, or a radioisotope. This mixture is then applied to a chromatographic medium containing a band or zone. This band or zone contains immobilized antibodies to the analyte of interest.
- Sample preparation and waste generation are responsible for other problems with currently available devices and techniques for immunochromatography.
- a sample such as feces
- a sampling device such as a throat swab
- Several extraction and pretreatment reactions are usually required before the sample can be applied to the chromatographic medium. These reactions are typically carried out by the physician or technician performing the test in several small vessels, such as test tubes, or microfuge tubes, requiring the use of transfer devices, such as pipettes. Each of these devices is then contaminated and must be disposed of using special precautions so that workers or people who may inadvertently come into contact with the waste do not become contaminated.
- test strip should be capable of performing two-directional or two-dimensional chromatography when used in clinical laboratories or physicians' offices.
- the device further comprises an absorbing means in operable contact with the second end of the chromatographic medium to enhance the flow of the sample through the chromatographic medium.
- At least one of the first and second opposable components can include an aperture therein for viewing of at least a portion of the chromatographic medium.
- a method for detecting and/or determining an analyte in a sample using this assay device can comprise the steps of:
- the detection reagent comprising at least one component capable of binding specifically to analyte present in the sample
- This device is suitable for bi-directional chromatography, combined with direct extraction of an analyte in situ.
- This embodiment of the device can be used for an assay method in which a detection reagent is applied as the second liquid to the second application means.
- the detection reagent comprises at least one component capable of binding specifically to analyte present in the sample.
- the first and second opposable components are brought into opposition. This causes the second application means to come into operable contact with the second end of the chromatographic medium so as to apply the second liquid to the second end of the chromatographic medium, and causes the absorbing means to come into operable contact with the first application means.
- the sample is applied to the first application means of the chromatographic assay device so that the sample flows through at least a portion of the chromatographic medium from the first end toward the second end.
- a detection reagent is then applied to the second application means, and the first and second opposable components are brought into opposition. This applies the detection reagent to the chromatographic medium.
- the detection reagent then flows through at least a portion of the chromatographic medium from the second end to the first end, so that the detection reagent gives a detectable indication of the presence and/or quantity of the analyte.
- bringing the first and second opposable components into opposition causes the first absorbing means to come into operable contact with the second conducting means to withdraw fluid from the chromatographic medium, and causes the first application means to come into operable contact with the first conducting means to apply fluid to the chromatographic medium, so that a first liquid applied to the first application means is drawn through at least a portion of the chromatographic medium.
- the first application means can contain a first specific binding partner for the analyte in a form that can be resolubilized by the application of an aqueous sample to the application means.
- This embodiment is particularly useful for indirect labeling, in which the first specific binding partner to the analyte is not itself labeled. Rather, a secondary specific binding partner specific for the first binding partner is labeled. This secondary specific binding partner is applied to the second application means to indirectly label the analyte.
- the first opposable component can further comprise a conducting means, and operable contact between the sample preparation means and the chromatographic medium is achieved by having the sample preparation means and the chromatographic medium both in operable contact with the conducting means.
- Another embodiment of an assay device according to the present invention comprises:
- Yet another version of a chromatographic assay device according to the present invention incorporating two application means on the second opposable component comprises:
- a first opposable component including:
- a chromatographic medium having first and second ends;
- a conducting means positioned such that it is not in operable contact with the first end of the chromatographic medium with the first opposable component and second opposable component are not in opposition;
- bringing the first and second opposable components into opposition causes the sample application pad to apply the sample to be tested to the detector application pad and thus to the first end of the chromatographic medium though the conducting means.
- the detector application pad and the sample application pad are in contact except for the region of the detector application pad directly adjacent to the first end of the chromatographic medium. Also, bringing the first and second opposable components into opposition causes the sample application pad to apply the sample to be tested to the detector application pad and thus to the first end of the chromatographic medium.
- Other embodiments of assay devices according to the present invention are suitable for performing multiple assays.
- One such embodiment comprises:
- a second opposable component including as many chromatographic media as are present sample preparation means on the first opposable component.
- the first and second opposable components can be brought into opposition so as to cause each sample preparation means to apply each sample to be tested to the corresponding chromatographic medium.
- At least one sample preparation means can comprise a collapsible well adapted for receiving a sample- containing device.
- Another multiplex device is adapted to receive a test card containing a plurality of dried specimens, such as stool samples.
- This device comprises:
- first opposable component adapted to receive the test card
- second opposable component including a reagent pad that is placed in contact with the specimens when the test card is placed in the first opposable component and the first and second opposable components are brought into opposition
- third opposable component including a plurality of chromatographic media, one for each sample to be tested.
- adding an aqueous reagent to the reagent pad, placing the first and second opposable components into opposition, and placing the second and third opposable components into opposition applies the sample and the contents of the reagent pad to the chromatographic media.
- Such a device can be used to detect hemoglobin in a fecal sample.
- Yet another chromatographic assay device of the present invention adapted to receive a test card comprises: (1) a first opposable component including a plurality of laterally separated reagent pads; and
- a second opposable component adapted to receive a test card containing a plurality of dried specimens
- the second opposable component including: (a) a chromatographic medium for each sample preparation means on the first opposable component, the chromatographic media being laterally separated, each chromatographic medium having a first and a second end; (b) a conducting means in operable contact with the first end of each chromatographic medium and in operable contact with each dried specimen of the test card; and
- Figure 2 is a drawing of a version of a two- component chromatographic assay device according to the present invention in which the first opposable component includes a sample preparation means and a chromatographic medium that is not in communication with the sample preparation means, and the second opposable component includes a conductive connecting member;
- Figure 3 is a drawing of another version of a two-component assay device according to the present invention with a sample preparation means incorporated into the first opposable component;
- Figure 5 is a drawing of yet another version of a two-component assay device according to the present invention incorporating a discontinuity between a conducting means and the chromatographic medium that is bridged when the device is closed;
- Figure 6A is a drawing of yet another version of a two-component assay device according to the present invention incorporating a detector application pad in operative contact with the chromatographic medium;
- Figure 6B is a side view of the two-component assay device of Figure 6A, showing details of the components in opposition;
- Figure 7A is a drawing of yet another version of a two-component assay device according to the present invention, generally similar to the version of Figure 6, but with the detector application pad in direct contact with the chromatographic medium;
- Figure 7B is a side view of the two-component assay device of Figure 7A, showing details of the components in opposition;
- Figure 8A is a drawing of a version of a two- component assay device according to the present invention suitable for carrying out bi-directional chromatography
- Figure 8B is a drawing of the two-component chromatographic assay device of Figure 8A shown with the two components having been brought into opposition;
- Figure 9A is a drawing of another version of a two-component assay device suitable for carrying out bi- directional chromatography with two absorbing means and a conducting means;
- Figure 9B is a drawing of the two-component chromatographic assay device of Figure 9A shown with the two components having been brought into opposition;
- Figure 10A is a drawing of yet another two- component assay device suitable for bi-directional chromatography, incorporating a cover;
- Figure 10B is a drawing of the two-component chromatographic assay device of Figure 10A shown with the two components having been brought into opposition;
- Figure 11A is a drawing of a three-component assay device according to the present invention.
- Figure 11B is a side view of the three- component assay device of Figure 11A, showing details of the components in opposition;
- Figure 12 is a drawing of a multiplex assay device according to the present invention, suitable for the simultaneous assay of one or more samples;
- Figure 13 is a drawing of another version of a multiplex assay device according to the present invention, containing a collapsible well to accommodate a sample;
- Figure 15 is a drawing of yet another version of a multiplex assay device according to the present invention adapted to receive a test card
- Figure 16 is a depiction of an assay device according to the present invention suitable for receiving a swab or similar sampling device and designed for detection of Streptococcus A antigen.
- Specific Binding Partner A member of a pair of molecules that interact by means of specific non- covalent interactions that depend on the three- dimensional structures of the molecules involved. Typical pairs of specific binding partners include antigen-antibody, hapten-antibody, hormone-receptor, nucleic acid strand-complementary nucleic acid strand, substrate-enzyme, inhibitor-enzyme, carbohydrate-lectin, biotin-avidin, and virus-cellular receptor.
- Operable Contact Two solid components are in operable contact when they are in contact, either directly or indirectly, in such a manner that an aqueous liquid can flow from one of the two components to the other substantially uninterruptedly, by capillarity or otherwise. "Direct contact” means that the two elements are in physical contact, such as edge-to-edge or front- to-back. "Indirect contact” means that the two elements are not in physical contact, but are bridged by one or more conducting means.
- An absorbing means has finite capacity when it becomes saturated by liquid received during the normal performance of an assay in the device in which the absorbing means is located. At that point, the absorbing means can release additional liquid absorbed and become at least partially conductive.
- One embodiment of the assay device of the present invention is a two-component chromatographic assay device operating in one dimension with one- directional flow.
- a two-component chromatographic assay device comprises: (1) A first opposable component including a sample preparation means adapted to receive a sample to be assayed; and
- a second opposable component including a chromatographic medium.
- the detection reagent comprises the first specific binding partner for the analyte as described above; it may comprise additional components.
- This process can give a qualitative and/or quantitative indication of the analyte, depending upon the density of the second specific binding partner in the detection zone and the size of the detection zone.
- Figure IB shows the device 10 after the opposable components 12 and 14 have been brought into opposition.
- the chromatographic medium 18, including the detection zone 20 and the control zone 22, is visible through window 34.
- the device 10 can, optionally, further comprise conducting means 35 in operable contact with the first end 19 of the chromatographic medium 18, as shown in Figure IA.
- the conducting means 35 can be a material such as cellulose or other material that can conduct an aqueous liquid without substantially absorbing it.
- the conducting means 35 can be treated with a surfactant so that the conjugate can be applied more evenly to the chromatographic medium.
- the device 10 can further comprise an absorbing means 36 in operable contact with the second end 21 of the chromatographic medium 18 to aid in drawing fluid through the chromatographic medium 18 from the first end 19 toward the second end 21, as shown in Figure IA.
- the sample preparation means can be made of any suitable material, such as, but not limited to, cellulose, paper, nylon, rayon, glass fiber, fleeces, or non-woven synthetic fabrics.
- the porosity of the sample preparation means can be chosen to filter out cellular or particulate matter in samples such as whole blood or fecal samples.
- the sample preparation means can contain at least one reagent for treatment of the sample before the sample is applied to the chromatographic medium.
- the reagents that can be present in the sample preparation means vary with the sample to be applied to the sample preparation means and with the analyte to be assayed. They can include, but are not limited to, acids or alkalis to adjust the pH, buffers to stabilize the pH, chelating agents such as EDTA or EGTA to chelate metals, hydrolytic enzymes to lyse the cell membrane of animal cells or the cell wall of bacteria to liberate analytes, substrates or co-enzymes for enzymes, and the like.
- One particularly useful extraction reagent is a mixture of sodium nitrite and acetic acid to generate nitrous acid. The sodium nitrite can be present in dried form on the sample preparation means, and the acetic acid can be added to the sample preparation means after the addition of the sample.
- the bodies of the first and second opposable components are preferably made of plastic that is impervious to moisture.
- a suitable plastic is a polycarbonate plastic such as LexanTM.
- LexanTM polycarbonate plastic
- other materials such as paperboard or solid bleached sulfite (SBS) , can be used.
- the chromatographic medium, absorbing means, conducting means, application means, and other liquid-receiving components are secured to the bodies of the first and second opposable components by adhesive.
- Suitable adhesives are well known in the art.
- the first and second opposable components preferably further comprise engaging means that secure the first and second opposable components in opposition.
- the engaging means can further comprise locking means.
- At least one of the first and second opposable components preferably contains a window or aperture so that the relevant portion of the chromatographic medium can be viewed.
- the window or aperture is located in the second opposable component.
- both the first and second opposable components can contain a window or aperture to allow viewing of the chromatographic medium from both sides.
- a sealing wedge or gasket can be provided around a perimeter of the opposable components to guard against leakage of samples or reagents.
- the analyte is detected either by means of a labelled specific binding partner to the analyte or by the use of a labelled secondary specific binding partner for a specific binding partner to the analyte. In most cases, the use of a labelled specific binding partner to the analyte is preferred.
- the label of the labelled specific binding partner is preferably a visually detectable label, such as a colloidal metal label.
- the colloidal metal label is gold, silver, bronze, iron, or tin; most preferably, it is gold.
- the preparation of gold-labelled antibodies is described in J. DeMey, "The Preparation and Use of Gold Probes," in Immunocytochemistry: Modern Methods and Applications (J.M. Polak & S.
- Antibodies labelled with colloidal gold are commercially available, such as from Sigma Chemical Company, St. Louis, Missouri.
- colloidal labels such as a colloidal sulfur label, can also be used.
- the labelled specific binding partner preferably is present on the sample preparation means in a form that can be resolubilized by the addition of an aqueous liquid to the sample preparation means.
- the aqueous liquid is the sample itself. In some cases, particularly where small sample volumes are used, it may be desirable to add additional buffer or other aqueous liquid to the sample preparation means.
- the labelled specific binding partner can be present on an element of the chromatographic assay device that is separate from the sample preparation means but comes into contact with it during the performance of the assay.
- the labelled specific binding partner is preferably present in a resolubilizable form on this element, and is resolubilized when the sample comes into contact with the element.
- the labelled specific binding partner can be resolubilized by the addition of a separate aqueous liquid, distinct from the sample, to the element.
- the visually detectable label can be a colored latex label. It is also possible to use other labels, such as radioactive labels.
- the chromatographic medium on the second opposable component is a flat strip. It is typically rectangular, having first and second ends. Throughout this Description, the term “first end” refers to the end of the chromatographic medium at which the sample is applied, and the term “second end” refers to the opposite end. The original direction of flow of the sample is from the first end toward the second end of the chromatographic medium.
- the chromatographic medium is composed of a material suitable as a medium for thin- layer chromatography of analytes and analyte-antibody conjugates, such as nitrocellulose, nylon, rayon, cellulose, paper, or silica.
- the chromatographic medium can be pretreated or modified as needed.
- the chromatographic medium is translucent, so that colored zones appearing on it as a result of the assay can be viewed from either side.
- a second flexible transparent support on the top of the chromatographic medium to regulate the flow of the sample through the membrane and prevent migration over the top of the membrane.
- Suitable flexible transparent supports include polyethylene, vinyl, Mylar ® , and cellophane.
- the chromatographic medium can further comprise a control zone substantially smaller than the chromatographic medium, and separate from the detection zone.
- the control zone can comprise analyte immobilized thereto non-diffusibly in order to bind labelled antibody that is not bound at the detection zone by the formation of a ternary "sandwich" complex. Any such antibody is bound by the immobilized analyte and forms a detectable zone or band. This provides a check on the operation of the assay and the correct binding of the reagents, as described below.
- the methods used to bind the second specific binding partner in the detection zone and the analyte in the control zone are well known in the art and need not be described further.
- control zone can comprise an immobilized zone of antibody specific for the labelled anti-analyte antibody.
- analyte is the analyte
- the sample preparation means can further contain a specific binding partner for the analyte labelled with a detectable label in a form that can be resolubilized by the addition of an aqueous liquid to the sample preparation means.
- the aqueous liquid can be the sample itself.
- the labelled specific binding partner can be freeze-dried or reversibly precipitated so that it is resolubilized and mobilized by the addition of the sample to the sample preparation means.
- the second opposable component can further comprise an absorbing means of finite capacity in operable contact with the first end of the chromatographic medium.
- the absorbing means is located so that it comes into contact with the sample preparation means when the first and second opposable components are placed into opposition.
- the sample is applied to the absorbing means when the first and second opposable components are brought into opposition. This may be useful in controlling the flow of sample into the chromatographic medium so that the chromatographic medium is not overloaded.
- the absorbing means can contain a labelled specific binding partner for the analyte in a form that can be resolubilized, as described above.
- the labelled specific binding partner is resolubilized when the first and second opposable components are brought into opposition, applying the sample to the absorbing means.
- the combination of the sample and the resolubilized labelled specific binding partner than enters the chromatographic medium at its first end.
- the first opposable component comprises:
- the sample is added to the sample preparation means 43.
- the sample preparation means 43 can be used for addition of labeled specific binding partner for the analyte in liquid form, with the sample itself being added to the conductive connecting member 47.
- the sample preparation means 43 can contain resolubilizable specific binding partner for the analyte, with the sample again being added to the conductive connecting member 47.
- a chromatographic assay device is a device that incorporates a sample preparation means on the first opposable component, i.e., the component on which the chromatographic medium is located.
- the second opposable component comprises an application means incorporating a labelled specific binding partner for the analyte in a form that can be resolubilized.
- the first opposable component further comprises a conducting means, and operable contact between the sample preparation means and the chromatographic medium is achieved by having the sample preparation means and the chromatographic medium both in operable contact with the conducting means.
- the chromatographic medium is preferably constructed as described above, with detection and control zones.
- the chromatographic assay device 60 has a first opposable component 62 and a second opposable component 64.
- the first opposable component 62 includes a sample preparation means 66, a conducting means 68 in operable contact with the sample preparation means 66, a chromatographic medium 70 having a first end 72 and a second end 74, and an absorbing means 76 in operable contact with the second end 74 of the chromatographic medium.
- the chromatographic medium 70 contains a detection zone 78 and a control zone 80.
- the second opposable component 64 contains an application means 82, preferably incorporating a labeled specific binding partner in a form that can be resolubilized.
- the first opposable component 62 and the second opposable component 64 are joined by a hinge 84.
- the second opposable component 62 contains a window 86 to allow viewing of the chromatographic medium 70.
- Yet another embodiment of a chromatographic assay device comprises two separate application means on the same element. These two application means are not in operable contact until they are bridged by a conducting means on the opposing element when the elements are brought into opposition.
- the chromatographic assay device 90 has a first opposable component 92 and a second opposable component 94.
- the first opposable component 92 comprises a chromatographic medium 96 having a first end 98 and a second end 100, a conducting means 102 in operable contact with the first end 98, and an absorbing means 104 in operable contact with the second end 100 of the chromatographic medium 96.
- the chromatographic medium 96 contains a detection zone 106 and a control zone 108.
- the second opposable component 94 contains a first application means (sample application pad) 110 and a second application means (detector application pad) 112.
- the first application means 110 and the second application means 112 are not in operable contact until the first opposable component 92 and the second opposable component 94 are brought into opposition.
- the first application means 110 and the second application means 112 are bridged by the conducting means 102 so that the contents of the first application means 110 and the second application means 112 are applied to the chromatographic medium 96.
- the first opposable component 92 and the second opposable component 94 are joined by a hinge 114.
- the second opposable component 94 contains a window 116 to allow viewing of the chromatographic medium 96.
- the first and second application means are positioned on the second opposable component such that they are not in operable contact when the first and second opposable components are not in opposition. Bringing the first and second opposable components into opposition places the conducting means in operable contact with the first application means and also with the second application means, thereby placing the first and second application means in operable contact with each other. Thus, bringing the first and second opposable components into opposition allows the contents of the first and second application means to react and applies the contents of both the first and second application means to the chromatographic medium. Chromatography and detection of the analyte then occur as described above.
- the first application means can comprise a sample application pad and the second application means can comprise a detector application pad, to which detecting reagent can be applied.
- the contents of the sample application pad and the detector application pad are applied to the chromatographic medium via the conducting means.
- the second application means contains a specific binding partner for the analyte labelled with a detectable label in a form that can be resolubilized by the addition of an aqueous liquid to the second application means.
- the aqueous liquid is typically the sample itself, which resolubilizes the labelled specific binding partner when the first and second opposable components are brought into opposition.
- the labelled specific binding partner can be applied in liquid form to the second application means.
- a further variation of this device incorporates a gap or discontinuity between the conducting means and the chromatographic medium so that the path of fluid flow is from the first application means through the conducting means, then through the second application means, and finally through the chromatographic medium.
- the chromatographic assay device 120 has a first opposable component 121 and a second opposable component 122.
- the first opposable component 121 comprises a chromatographic medium 123 having a first end 124 and a second end 125, a conducting means 126 not in operable contact with the first end 124 of the chromatographic medium 123 when the device 120 is in open position, and an absorbing means 127 in operable contact with the second end 125 of the chromatographic medium 123.
- the chromatographic medium 123 contains a detection zone 128 and a control zone 129.
- the second opposable component 122 contains a first application means (sample application pad) 130 and a second application means (detector application pad) 131.
- the first application means 130 and the second application means 131 are not in operable contact until the first opposable component 121 and the second opposable component 122 are brought into opposition.
- the first application means 130 and the second application means 131 are bridged by the conducting means 126.
- the path of fluid flow is from the first application means 130 through the conducting means 126, then through the second application means 131, and then into the chromatographic medium 123.
- the second opposable component 122 contains a window 132 to allow viewing of the chromatographic medium 123.
- a chromatographic assay device is a two- component device incorporating a pad for a labelled specific binding partner on the same opposable component as the chromatographic medium.
- the sample application means is located on the other opposable component.
- the chromatographic assay device 140 has a first opposable component 142 and a second opposable component 144.
- the first opposable component 142 has a chromatographic medium 146 having a first end 148 and a second end 150.
- the chromatographic medium has a detection zone 162 and a control zone 164.
- the first opposable component 142 also has a conducting means 152 in operable contact with the first end 148 of the chromatographic medium 146, and an absorbing means 154 in operable contact with the second end 150 of the chromatographic medium 146.
- the first opposable component 142 also has a detector application pad 156 in direct contact with the conducting means 152 and positioned such that it is in indirect contact with the first end 148 of the chromatographic medium 146.
- the second opposable component 144 has a sample application pad 158.
- the first opposable component 142 and the second opposable component 144 are joined by a hinge 160. When the first opposable component 142 and the second opposable component 144 are brought into opposition, the sample application pad 158 is brought into contact with the detector application pad 156.
- the second opposable component 144 contains a window 166 to allow viewing of the chromatographic medium 146.
- a side view of the device 140 is depicted in
- Figure 6B The section shown in Figure 6B is taken from the view of Figure 6A between the chromatographic medium 146 and the hinge 160 looking toward the edge opposite the hinge 160.
- Figure 6B shows the first opposable component 142 and second opposable component 144 in opposition.
- the sample application pad 158 is shown in contact with the detector application pad 156.
- the detector application pad 156 is in contact with the conducting means 152, which is in turn in contact with the first end 148 of the chromatographic medium 146.
- the detection zone 162 and control zone 164 of the chromatographic medium 146 are shown.
- the second end 150 of the chromatographic medium 146, nearer the control zone 164, is in contact with the absorbing means 154.
- the detector application pad contains a first specific binding partner to the analyte in a form that can be resolubilized by addition of an aqueous liquid to the detector application pad, and the first specific binding partner is labelled with a detectable label.
- the chromatographic medium further comprises a detection zone substantially smaller in area than the chromatographic medium, as described above. In this arrangement, a ternary complex comprising the first (labelled) specific binding partner, the analyte, and the second specific binding partner forms at the detection zone if analyte is present in the sample. This ternary complex is what is detected or determined.
- the contents of the sample application pad after a sample is applied thereto comprises an aqueous liquid
- the aqueous liquid applied to the detector application pad comprises the contents of the sample application pad.
- a variation of this device omits the conducting means between the detector application pad and the chromatographic medium, so that the detector application pad is in direct contact with the first end of the chromatographic medium.
- the detector application pad and the sample application pad are in contact except for the region of the detector application pad directly adjacent to the first end of the chromatographic medium.
- This gap or offset is typically from about 0.5 mm to about 2 mm, more typically from about 0.5 mm to about 1 mm.
- This variation is particularly suitable for the detection of fecal occult blood by use of a labelled anti-hemoglobin antibody, and can detect concentrations of hemoglobin corresponding to as much as 17 ml of blood per 100 g feces (13 mg hemoglobin per gram of feces) , without the occurrence of false negatives due to a high dose "hook" effect.
- the chromatographic assay device 180 has a first opposable component 182 and a second opposable component 184.
- the first opposable component 182 has a chromatographic medium 186 having a first end 188 and a second end 190.
- the chromatographic medium has a detection zone 202 and a control zone 204.
- the first opposable component 182 also has an absorbing means 192 in operable contact with the second end 190 of the chromatographic medium 186.
- the first opposable component 182 also has a detector application pad 194 in direct contact with the first end 188 of the chromatographic medium 186.
- the second opposable component 184 has a sample application pad 196.
- FIG. 7B A side view of the device 180 of Figure 7A is depicted in Figure 7B.
- the section shown in Figure 7B is taken from the view of Figure 7A between the chromatographic medium 186 and the hinge 198 looking toward the edge opposite the hinge 190.
- Figure 7B shows the first opposable component 182 and second opposable component 184 in opposition, with the hinge 198 in closed position.
- the sample application pad 196 is shown in contact with the detector application pad 194, except for a small gap 200 at the end of the detector application pad 194 nearest the chromatographic medium 186. This gap 200 prevents sample applied to the sample application pad 196 from flowing directly into the chromatographic medium 186.
- the detector application pad 194 is in direct contact with the first end 188 of the chromatographic medium 186.
- Another embodiment of a chromatographic assay device comprises a device capable of carrying out bi-directional chromatography.
- the device 250 When the hinge 272 is closed, the device 250 appears as shown in Figure 8B.
- addition of a first liquid to the first application means causes the first liquid to be applied to the first end of the chromatographic medium.
- Bringing the first and second opposable components into opposition then causes the second application means to come into operable contact with the second end of the chromatographic medium so as to apply a second liquid to the second end of the chromatographic medium, and causes the absorbing means to come into operable contact with the first application means so as to withdraw fluid from the chromatographic medium through the first application means.
- the sample is applied to the first application means and a solution of a labelled specific binding partner is applied to the second application means.
- the sample then moves through the chromatographic medium from the first end to the second end so that any analyte present in the sample is bound to the immobilized antibody at the detection zone.
- the labelled specific binding partner is applied to the chromatographic medium and moves to the chromatographic medium from the second end to the first end.
- the labelled specific binding partner then binds to any analyte bound to the immobilized antibody at the detection zone, generating a detectable ternary complex.
- the device can also comprise a control zone containing the immobilized analyte.
- the arrangement of the components, except for the addition of the second application means and the absorbing means, is substantially similar to that of the basic device described above. e. Bi-Directional Device Containing Two Absorbing Means and Conducting means
- the assay device 300 has a first opposable component 302 and second opposable component 304.
- the first opposable component 302 has a chromatographic medium 306 having a first end 308 and a second end 310. Adjacent to and in operable contact with the first end 308 of the chromatographic medium 306 is a first application means 312. Adjacent to and in operable contact with the second end 310 of the chromatographic medium 306 is a conducting means 314.
- the chromatographic medium 306 contains a detection zone 316, and optionally, a control zone 318.
- the second opposable component 304 comprises an absorbing means 320 and a second application means 322. The first and second opposable components 302 and 304 are joined by a hinge 324.
- the second opposable component 304 contains a window 326 to permit viewing of the chromatographic medium 306.
- the absorbing means 320 is brought into operable contact with the first application means 312, and the second application means 322 is brought into operable contact with the conducting means 314, thereby reversing the flow.
- the portion of the chromatographic medium 306, including the detection zone 316 and, if present, the control zone 318, can be viewed through the window 326 in the second opposable component 304 when the first 302 and second 304 opposable components are placed into opposition.
- the first application means can comprise a sample application pad and the second application means can comprise a buffer application pad to which buffer is added.
- the first application means can contain at least one reagent for treatment of the sample before it is applied to the chromatographic medium, as described above.
- the second application means typically contains a specific binding partner for the analyte in a form that can be reconstituted by the addition of an aqueous liquid, as described above.
- the chromatographic medium can include detection and control zones, as described above.
- the first application means can be placed into operable contact with the first end of the chromatographic medium by contacting the first application means with a conducting means that is itself in operable contact with the first end of the chromatographic medium.
- the sample to be tested is applied to the first application means (sample application pad) and a buffer solution is applied to the second application means (buffer application pad) .
- the sample migrates across the chromatographic medium and passes the detection zone, where analyte binds the immobilized specific binding partner.
- the migration of sample is monitored by observing the inert dye.
- the first and second opposable components are brought into opposition and the absorbent pad is brought into contact with the first application means. This reverses the flow of the sample along the chromatographic medium, allowing additional capture of the analyte.
- a buffer solution containing resolubilized labelled specific binding partner to the analyte
- the buffer solution migrates through the chromatographic medium from the second end of the chromatographic medium to the first end.
- labelled specific binding partner to the analyte binds to the analyte already bound to the detection zone. Detection and/or determination of the analyte is then performed as described above.
- first and second opposable components are not in contact when the sample is applied as the first liquid to the first application means, it is possible to apply either the sample or the buffer to reconstitute the labelled specific binding partner first.
- a variation of this bi-directional device replaces the conducting means on the first opposable component with a first absorbing means of finite capacity.
- the absorbing means on the second opposable component then is a second absorbing means.
- the absorbing means of finite capacity on the first opposable component has the property that liquid can be drawn back through it when the second application means is placed in operable contact with it and the second absorbing means is placed in operable contact with the first application means.
- the assay device 340 has a first opposable component 342, a second opposable component 344, and a cover 346.
- the second opposable component 344 is hingedly attached to one side of the first opposable component 342 by a first hinge 348.
- the cover 346 is hingedly attached to the opposite side of the first opposable component 342 at a second hinge 350.
- the first opposable component 342. has a chromatographic medium 352 having a first end 354 and a second end 356. Adjacent to and in operable contact with the first end 354 of the chromatographic medium 352 is a first application means or sample pad 358 which is located in a recess 360.
- a first absorbing means 361 is adjacent to and in operable contact with the second end 356 of the chromatographic medium.
- the chromatographic medium 352 contains a detection zone 362 and a control zone 364 and is optionally marked with a limit line 366.
- the limit line 366 can be optionally marked on the first opposable component 342 as well.
- the second opposable component 344 comprises a second application means 368 and a second absorbing means 370.
- the cover 346 contains a first aperture 372.
- the second opposable component 344 contains a second aperture 374.
- the addition of a first liquid to the first application means causes the first liquid to be applied to the first end of the chromatographic medium.
- the first liquid is a sample that may contain an analyte.
- the function of the recess in the first opposable component is to position the second absorbing means so that can be placed at least partially in direct contact with the chromatographic medium in order to remove excess sample, while keeping the first application means from blocking this contact. Were the recess not present, direct contact would be blocked by the first application means itself and removal of excess sample would be less efficient.
- the first application means contains a first specific binding partner for the analyte in a form that can be resolubilized by the application of an aqueous sample to the first application means.
- the first specific binding partner can be directly labelled with a detectable label.
- indirect labelling of the first specific binding partner can be used. Indirect labeling is particularly useful for testing for Giardia or other antigens for which commercially available antibodies are directly labelled only with difficulty.
- the second application means preferably contains a labelled secondary specific binding partner for the first specific binding partner, as discussed below in Section II.
- Each of the chromatographic media that comprise the device preferably contains a detection zone and control zone, as described above.
- the second opposable component has an aperture 522 for viewing of a portion of the chromatographic media 516, including the detection zone 518 and the control zone 520.
- samples in the control well 512 and the collapsible sample well 514 are applied to the corresponding chromatographic media 516 for chromatography.
- Yet another variation of the multiplex device is particularly useful for determination of hemoglobin in fecal occult blood.
- This device is adapted to receive a test card that includes several dried fecal samples, typically taken on consecutive days.
- the third opposable component 548 has an aperture 564 to permit viewing of at least a portion of the chromatographic media 558, including each detection zone 560 and control zone 562.
- the second opposable component 544 is folded over the first opposable component 542 after adding reagents to reagent pad 556 of the second opposable component 544.
- the second opposable component 544 is then unfolded from the first opposable component 542; finally, the third opposable component 548 is folded over the second opposable component 544 to apply the contents of the reagent pad 556 and sample to the chromatographic media 558.
- a multiplex device is a multiplex device similar to that shown in Figure 12, but adapted to receive a test card.
- the test card can contain a plurality of samples, such as dried fecal samples when a fecal occult blood test is performed.
- the first opposable component 602 is adapted to receive a test card 622 containing a plurality of dried specimens 624 positioned so that they are in operable contact with each conducting means 614.
- the second opposable component 604 comprises a plurality of application means 628, one for each chromatographic medium 608.
- each application means 628 contains labeled specific binding partner for the analyte in resolubilizable form.
- the first and second specific binding partners are preferably antibodies'. In many applications, it is preferable that the first and second specific binding partners are antibodies to different epitopes on the analyte, but this is not required.
- the antibodies can be polyclonal or monoclonal, and can be IgG, IgM or IgA. In many applications, polyclonal antibodies are preferred, as their natural variability may allow more accurate detection in systems where antigenic polymorphisms exist or may exist.
- the first specific binding partner is typically a labelled antibody that binds to the analyte on the basis of species, class, or subclass (isotype) specificity. It is highly preferred that the first specific binding partner to an antibody analyte binds to the constant region of the antibody analyte, in order to prevent interference.
- the second specific binding partner is preferably an antigen or hapten for which the antibody analyte is specific.
- the first specific binding partner can be conjugated to biotin and an avidin- conjugated label can be used.
- Chromatographic assay devices can readily be adapted for the performance of competitive immunoassays for analytes that bind antibodies in a monovalent manner, such as drugs and other haptens.
- the labeled conjugate is an antibody-label conjugate and the detection zone comprises immobilized analyte analogue.
- the antibody-label conjugate is present along with a quantity of unlabeled antibody sufficient to prevent binding of the antibody-label conjugate to the immobilized analyte analogue in the absence of analyte in the test sample.
- test kits that can be used to detect particular analytes.
- a test kit comprises:
- the components required in (2) and (3) are packaged separately and can be in liquid or solid form (freeze-dried, crystallized, precipitated, or aggregated) . If the latter, they are resolubilized by the user, typically with distilled or purified water, with physiological saline, or a buffer solution.
- Figure 16 shows a chromatographic assay device 700 according to the present invention with a first opposable component 702, a second opposable component 704 hingedly attached to the first opposable component 702, and a cover 706 hingedly attached to the second opposable component 704.
- the first opposable component 702 includes a chromatographic medium 708.
- the second opposable component 704 includes a teardrop-shaped well 710 held in place by a ribbon 712.
- the first opposable component 702 contains a first window 714 and the cover contains a second window 716.
- the chromatographic medium was a nitrocellulose strip 8 ⁇ m thick and 0.5" in length, (MSI, Westborough, Mass.) , affixed to the plastic backing by means of double-sided tape (3M, Minneapolis, Minnesota) .
- the conducting means and absorbing means were cellulose strips (Ahlstrom Filtration, Holly Springs, Pennsylvania) , 17/32" in length for the absorbing means, which was Ahlstrom Grade 939, and 0.25" in length for the conducting means, which was Ahlstrom Grade 1281.
- the detector application pad was also Ahlstrom Grade 1281, and was 0.375" wide. The detector application pad overlapped slightly with the conducting means, which in turn overlapped slightly with the chromatographic medium at its first end.
- the chromatographic medium overlapped slightly at its second end with the absorbing means.
- the required reagents were first incorporated in the chromatographic medium and the detector application pad, after which the device was assembled using double-sided tape to hold the components to the backing.
- the detection zone comprised rabbit anti- Streptococcus A antibody at 2 mg/ml in 0.001 mole/1 phosphate buffered saline, pH 7.2.
- the control zone comprised goat anti-rabbit IgG at a similar concentration in the same buffer.
- the antibody solutions were applied to the appropriate regions of the chromatographic medium and dried at 100°F in a low humidity environment.
- the chromatographic medium was wet in excess blocking solution (Blocking Reagent for ELISA, Boehringer Mannheim, Mannheim, Germany, diluted 1:10 with distilled water containing 0.2% Tween 20) and again dried at 100°F.
- the detector application pad contained rabbit anti-Streptococcus antibody labelled with 40-nm colloidal gold particles.
- the labelled antibody was diluted 1:1.5 with DBN (1.5 mole/1 Tris-HCl, pH 7.4, 1% (v/v) Tween 20, 0.4% (v/v) Brij 35, 0.02% (w/v) sodium azide, 3 mg/ml rabbit IgG) .
- DBN 1.5 mole/1 Tris-HCl, pH 7.4, 1% (v/v) Tween 20, 0.4% (v/v) Brij 35, 0.02% (w/v) sodium azide, 3 mg/ml rabbit IgG) .
- 15 ⁇ l of diluted labelled antibody was added to the detector application pad.
- the detector application pad was dried for 30 minutes at 100°F.
- Example 1 The device of Example 1 was used to detect Streptococcus A antigen.
- Three drops of Extraction Reagent A (0.25% acetic acid, 5% Tween 20) , and three drops of Extraction Reagent B (2 mole/1 sodium nitrite, 5% Tween 20) were added to the swab, mixed by gently rotating the swab, and incubated for one minute.
- the device was then closed, so that the first and second opposable components were brought into contact, and the cover was then folded over the first opposable component.
- the result was read after an incubation period of from 2 minutes to 5 minutes.
- the development of a pink-red band in the detection zone of the chromatographic medium indicated the detection of Streptococcus A antigen.
- the device of Example 1 could detect 1x10 s Streptococcus A organisms after a 2-minute incubation, and could detect 5x10 4 Streptococcus A organisms after a 5-minute incubation.
- the ConciseTM immunoassay of Hybritech (La Jolla, California) could detect 1x10 s Streptococcus A organisms only after a 5- minute incubation, and could not detect 5xl0 4
- An assay device for the detection of hemoglobin in fecal occult blood is constructed according to Figures IA and IB, incorporating the optional conducting means at the first end of the chromatographic medium.
- a labeled specific binding partner is applied to the sample application pad in resolubilizable form.
- the labeled specific binding partner is goat anti-human hemoglobin antibody labeled with colloidal gold.
- a fecal sample of 60 ⁇ l is applied to the sample application pad and allowed to mix with conjugate. The device is closed and the combination of the fecal sample and reconstituted antibody contacts the conducting means and moves through the chromatographic medium. Chromatography is allowed to proceed for a period of about l minute to about 5 minutes.
- the chromatographic medium contains a detection zone of immobilized anti-human Hb antibody, and a control zone of immobilized rabbit anti-goat IgG antibody. Color appearing at both the detection zone and the control zone indicates a positive result, i.e., the presence of occult blood in the fecal sample. Color appearing at the control zone, but not at the detection zone, indicates the absence of occult blood and the correct performance of the test.
- This device is capable of detecting hemoglobin in fecal occult blood in a concentration range of from about 0.2 ml blood/100 g feces to about 17 ml blood/100 g feces. This device is free from interference caused by peroxidase and dietary (non-human) hemoglobin.
- Chromatographic assay devices allow the rapid and accurate detection of clinically important analytes, such as Streptococcus A and B antigen, hemoglobin for the determination of fecal occult blood, and antibody to Helicobacter pylori.
- the construction of the devices allows more even application of the samples to the chromatographic medium, and reduces interference that might otherwise be introduced by particulates or colored samples.
- the use of colloidal metal labels in a resolubilizible form provides extremely rapid kinetics of labeling and allows substantially complete formation of binary analyte-label complexes before the sample is applied to the chromatographic medium. This aids in the separation of contaminants and improves the performance of the assay.
- the construction and arrangement of the housing of the device aids in the performance of the assay by assuring the withdrawal of excess immunoglobulin-containing sample that could otherwise create interference.
- Extraction of biological samples such as blood, sputum, or feces can be performed directly in the devices, reducing the quantity of contaminated material that must be disposed and reducing the likelihood of accidental infection of physicians, technicians, or the public by such contaminated material. Additionally, the devices are capable of performing bi-directional chromatography to further increase accuracy and reduce interference. Test methods using devices according to the present invention have a wide dynamic range and are substantially free from false negatives that may occur in other test methods at high concentrations of analyte.
Abstract
Description
Claims
Priority Applications (7)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP92913737A EP0586595B1 (en) | 1991-05-29 | 1992-05-27 | Assay device |
DE69227834T DE69227834T2 (en) | 1991-05-29 | 1992-05-27 | TEST DEVICE |
CA002103052A CA2103052C (en) | 1991-05-29 | 1992-05-27 | Assay device |
AU21852/92A AU665956B2 (en) | 1991-05-29 | 1992-05-27 | Assay device |
DK92913737T DK0586595T3 (en) | 1991-05-29 | 1992-05-27 | Test Device |
JP50052293A JP3386122B2 (en) | 1991-05-29 | 1992-05-27 | Testing device |
FI935244A FI935244A (en) | 1991-05-29 | 1993-11-25 | BESTAEMNINGSANORDNING |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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US07/706,639 US6168956B1 (en) | 1991-05-29 | 1991-05-29 | Multiple component chromatographic assay device |
US706,639 | 1991-05-29 |
Publications (1)
Publication Number | Publication Date |
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WO1992021977A1 true WO1992021977A1 (en) | 1992-12-10 |
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Application Number | Title | Priority Date | Filing Date |
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PCT/US1992/004425 WO1992021977A1 (en) | 1991-05-29 | 1992-05-27 | Assay device |
Country Status (11)
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US (1) | US6168956B1 (en) |
EP (3) | EP1376130B1 (en) |
JP (1) | JP3386122B2 (en) |
AT (1) | ATE174432T1 (en) |
AU (1) | AU665956B2 (en) |
CA (1) | CA2103052C (en) |
DE (3) | DE69233290T2 (en) |
DK (1) | DK0586595T3 (en) |
ES (1) | ES2127754T3 (en) |
FI (1) | FI935244A (en) |
WO (1) | WO1992021977A1 (en) |
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Also Published As
Publication number | Publication date |
---|---|
EP1376130B1 (en) | 2005-08-24 |
FI935244A0 (en) | 1993-11-25 |
JPH06508215A (en) | 1994-09-14 |
DE69233290D1 (en) | 2004-02-26 |
DE69227834T2 (en) | 1999-04-29 |
EP0874241A1 (en) | 1998-10-28 |
FI935244A (en) | 1993-11-25 |
JP3386122B2 (en) | 2003-03-17 |
DE69227834D1 (en) | 1999-01-21 |
CA2103052A1 (en) | 1992-11-30 |
AU2185292A (en) | 1993-01-08 |
EP1376130A2 (en) | 2004-01-02 |
DE69233546D1 (en) | 2005-09-29 |
DK0586595T3 (en) | 1999-08-16 |
US6168956B1 (en) | 2001-01-02 |
EP0586595B1 (en) | 1998-12-09 |
DE69233546T2 (en) | 2006-05-18 |
ATE174432T1 (en) | 1998-12-15 |
EP0586595A1 (en) | 1994-03-16 |
AU665956B2 (en) | 1996-01-25 |
ES2127754T3 (en) | 1999-05-01 |
DE69233290T2 (en) | 2004-11-18 |
EP0874241B1 (en) | 2004-01-21 |
EP1376130A3 (en) | 2004-01-14 |
CA2103052C (en) | 2005-12-27 |
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