WO2003008933A2 - Test strip for a lateral flow assay - Google Patents

Test strip for a lateral flow assay Download PDF

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Publication number
WO2003008933A2
WO2003008933A2 PCT/US2002/023164 US0223164W WO03008933A2 WO 2003008933 A2 WO2003008933 A2 WO 2003008933A2 US 0223164 W US0223164 W US 0223164W WO 03008933 A2 WO03008933 A2 WO 03008933A2
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WO
WIPO (PCT)
Prior art keywords
sample
pad
strip
test strip
fluid
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Ceased
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PCT/US2002/023164
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English (en)
French (fr)
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WO2003008933A3 (en
Inventor
Siliang Zhou
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Individual
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Individual
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Priority to CA2452948A priority Critical patent/CA2452948C/en
Priority to EP02768331A priority patent/EP1417491A4/en
Priority to JP2003514229A priority patent/JP2004538453A/ja
Priority to AU2002330899A priority patent/AU2002330899B2/en
Publication of WO2003008933A2 publication Critical patent/WO2003008933A2/en
Publication of WO2003008933A3 publication Critical patent/WO2003008933A3/en
Anticipated expiration legal-status Critical
Priority to US12/580,981 priority patent/US20100092945A1/en
Ceased legal-status Critical Current

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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
    • 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
    • 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
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer 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
    • G01N33/53—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
    • 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
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
    • 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
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T436/00—Chemistry: analytical and immunological testing
    • Y10T436/25—Chemistry: analytical and immunological testing including sample preparation
    • Y10T436/25375—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
    • Y10T436/255—Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.] including use of a solid sorbent, semipermeable membrane, or liquid extraction

Definitions

  • This invention relates to the field of medicine and diagnostics.
  • the invention relates to lateral flow assay for the detection of an analyte in a sample containing whole cells, such as blood cells in a blood sample.
  • the PraxSys device contains a test strip that is not suitable for use when the sample to be analyzed contains whole cells, such as a blood sample containing red blood cells. Therefore, there remains an unmet need for a test strip that can be used for detection of an analyte in a sample containing whole cells.
  • U.S. Patent No. 5,240,862 describes blood separation materials. However, this separation methodology requires the use of a separation membrane and a collection membrane in a device, removal of the separation membrane from the collection membrane, and use of the collection membrane for further analysis. This methodology is cumbersome and is not suitable for use in a lateral flow assay. Thus, there also remains a need for simpler methods for detection of an analyte in a sample containing whole cells.
  • test strip that is commercially usable for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid.
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the chromatographic strip; where the sample filter is capable of separating the cells in the sample from fluid in the sample and allows the fluid to pass through to the chromatographic strip, and where the test strip supports lateral flow of the fluid from the sample filter towards the second end of the chromatographic strip.
  • test strip as described herein, where the sample that can be analyzed is a sample of body fluids.
  • the sample is a blood sample, a saliva sample, a urine sample, sample taken from lymphatic tissues, a sample from a spinal tap, or a sample taken from a peritoneal cavity, synovial fluid from a joint, or fluid from lungs.
  • test strip as above, where the sample filter comprises a surface that contacts the sample and the surface is hydrophilic.
  • test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the chromatographic strip and where the sample filter comprises pores of varying pore sizes to allow the cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample filter towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface, and first and second pores, where the lower surface of the sample filter is in capillary contact with the chromatographic strip, the first pores are closer to the upper surface of the sample filter and the second pores are closer to the lower surface of the sample filter, the first pores comprising a first pore size and the second pores having a second pore size, and where the first pore size is larger than the second pore size, the sample filter allows the cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample filter towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains red blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the chromatographic strip; and where the sample filter is capable of separating the red blood cells in the sample from fluid in the sample, and allows the fluid to pass through to the chromatographic strip, and the test strip supports lateral flow of the fluid from the sample filter towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains red blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the chromatographic strip and where the sample filter comprises pores of varying pore sizes to allow the red blood cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample filter towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains red blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; and (b) a sample filter having an upper surface and a lower surface and first and second pores, where the lower surface of the sample filter is in capillary contact with the chromatographic strip, the first pores are closer to the upper surface of the sample filter and the second pores are closer to the lower surface of the sample filter, the first pores comprising a first pore size and the second pores comprising a second pore size, and where the first pore size is larger than the second pore size, the sample filter allows the cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample filter towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad; and where the sample filter is capable of separating the cells in the sample from fluid in the sample and allows the fluid to pass through, the sample pad also allows the fluid to pass through to the chromatographic strip, and the test strip supports lateral flow of fluid in the sample from the sample pad towards the second end of the chromatographic strip.
  • test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, and where the sample filter comprises pores of varying pore sizes to allow the cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample pad towards the second end of the chromatographic strip.
  • test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface and first and second pores, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, the first pores are closer to the upper surface of the sample filter and the second pores are closer to the lower surface of the sample filter, the first pores comprising a first pore size and the second pores comprising a second pore size, and where the first pore size is larger than the second pore size, the sample filter
  • a test strip as described herein further comprising a selective membrane, where the selective membrane is positioned under the sample filter.
  • the selective membrane which lies on top of the sample pad.
  • the selective membrane lies on top of the chromatographic strip.
  • the selective membrane is in capillary contact with the sample filter and the sample pad or the chromatographic strip to allow fluid to pass through the selective membrane under capillary or osmotic forces.
  • the selective membrane contains an agent that can selectively bind to a component in the sample to effectively remove the component from the assay environment.
  • one or more other filters or membranes between the sample filter and the chromatographic strip for one or more purposes, provided that the additional one or more membranes do not impair the capillary or osmotic flow of fluid from the sample filter to the chromatographic strip, and provided that the height of the combined filters or membranes does not impair the ability of the test strip to be fitted in a cassette to be read in an instrument.
  • the selective membrane as above contains an agent that is an antibody, an antigen, a metabolite, a hormone, an enzyme, a virus, a prion, or parts thereof, or an agent that binds to such.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, and where the sample filter is capable of separating the red blood cells in the sample from fluid in the sample and allows the fluid to pass through, the sample pad also allows the fluid to pass through to the chromatographic strip, and the test strip supports lateral flow of fluid in the sample from the sample pad towards the second end of the chromatographic strip.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains red blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, and where the sample filter comprises pores of varying pore sizes to allow the red blood cells from the sample to be retained in the sample filter and the fluid in the sample to pass through the sample filter; and where the test strip supports lateral flow of fluid in the sample from the sample pad towards the second end of the chromatographic strip.
  • test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains blood cells
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; and (c) a sample filter comprising an upper surface and a lower surface and first and second pores, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, the first pores are closer to the upper surface of the sample filter and the second pores are closer to the lower surface of the sample filter, the first pores comprising a first pore size and the second pores comprising a second pore size, and where the first pore size is larger than the second pore size, the sample
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated close to the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad; (d) a conjugate pad situated at or close to the second end of the chromatographic strip, where the conjugate pad comprises an upper surface and a lower surface, and the lower surface of the conjugate pad is in capillary contact with the chromatographic strip; (e) a reagent pad comprising an upper surface and
  • test strip as described herein, where reagent pad is suitable for application of a reagent, such as a buffer, to release the conjugate from the conjugate pad.
  • reagent pad is suitable for application of a reagent, such as a buffer, to release the conjugate from the conjugate pad.
  • a reagent pad that may be the same or different from the sample filter.
  • a sample can be applied to the reagent pad to release the conjugate from the conjugate pad, but only if the sample does not react with the conjugate to form any complexes that would impair the capillary or osmotic flow of the fluid onto the chromatographic strip for conduct of the assay.
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains whole cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated at the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad and where the sample filter comprises varying pore sizes and allows the cells to be retained in the sample filter and the fluid to pass through the sample filter; (d) a conjugate pad situated at the second end of the chromatographic strip, where the conjugate pad comprises an upper surface and a lower surface, and the lower surface of the conjugate pad is in
  • test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains whole cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated at the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; (c) a sample filter comprising an upper surface and a lower surface and first and second pores, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad, the first pores are closer to the upper surface of the sample filter and the second pores are closer to the lower surface of the sample filter, the first pores comprising a first pore size and the second pores comprising a second pore size, and where the first pore size is larger than the second pores size, the sample
  • a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains blood cells and fluid
  • the test strip comprises: (a) a first membrane that comprises a chromatographic strip, where the chromatographic strip comprises a first end and a second end; (b) a sample pad situated at the first end of the chromatographic strip, where the sample pad comprises an upper surface and a lower surface, and the lower surface of the sample pad is in capillary contact with the chromatographic strip; (c) a sample filter comprising an upper surface and a lower surface, where the lower surface of the sample filter is in capillary contact with the upper surface of the sample pad and the sample filter is capable of separating red blood cells from fluid in the sample; (d) a conjugate pad situated at the second end of the chromatographic strip, where the conjugate pad comprises an upper surface and a lower surface, and the lower surface of the conjugate pad is in capillary contact with at least a portion of the test strip
  • a test strip as described herein, further comprising: (d) a conjugate pad situated between the sample pad and the second end of the chromatographic strip, where the conjugate pad comprises an upper surface and a lower surface, and the lower surface of the conjugate pad is in capillary contact with the chromatographic strip; and (f) an absorbent pad situated at the second end of the chromatographic strip, where the absorbent pad is in capillary contact with the chromatographic strip; and where the test strip is capable of supporting lateral flow of fluid in the sample from the sample pad towards the conjugate pad.
  • test strip as described herein adapted for conduct of an immunoassay on the chromatographic strip for detection of an analyte in a sample containing cells and fluid.
  • the test strip comprises a conjugate that can be released from the conjugate pad upon application of fluid to the conjugate pad, where the conjugate is capable of combining with the analyte to be detected to form a detectable signal, indicating the presence of the analyte.
  • the conjugate comprises a first binding agent that is capable of binding to the analyte.
  • the first binding agent examples include an antibody and an antigen
  • the conjugate comprises a second binding agent, where the second binding agent comprises a detectable marker and binds either to the first binding agent or to the analyte.
  • the detectable signal can be quantified.
  • the immunoassay of the present invention is a quantitative immunoassay.
  • a test strip as described herein, where the chromatographic strip supports the capillary flow of fluid from the sample filter situated close to the first end of the chromatographic strip to the second end of the chromatographic strip, and the capillary flow of conjugate, released from the conjugate pad, from the second end of the chromatographic strip towards the first end of the chromatographic strip, allowing the conjugate to come into contact with the fluid from the sample to form an immobilized complex, and allowing the detection of the complex.
  • test strip as described herein, where the conjugate pad is situated in any appropriate location on the chromatographic strip to allow and facilitate the conduct of the immunoassay.
  • a conjugate pad that is situated between the sample filter and the second end of the chromatographic strip, and the chromatographic strip supports the flow of fluid from the sample filter to the conjugate pad to release the conjugate.
  • a conjugate pad that is situation under the sample filter and is in capillary contact with the sample filter and the chromatographic strip and allows the flow of fluid from the sample filter through the conjugate pad to the chromatographic strip.
  • a chromatographic strip that comprises a chromatographic membrane, an adhesive layer and a backing for the adhesive layer.
  • a chromatographic membrane that is made of nitrocellulose.
  • a sample filter that is a blood cell/plasma separation membrane encoded S/G available from Spectral Diagnostics Inc.
  • a method of making a test strip for conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid comprising the steps of: (a) providing a chromatographic strip having a first end and a second end; and (b) providing a sample filter that comprises an upper and a lower surface close to the first end of the chromatographic strip, where the lower surface of the sample filter is in capillary contact with the chromatographic strip to allow flow of fluid capillary contact between the sample filter and the chromatographic strip, where the test strip supports lateral flow of fluid from the sample filter to the second end of the chromatographic strip.
  • the method of making a test strip as described herein further comprising the step of: (c) placing a sample pad between the sample filter and the chromatographic strip, where the sample pad is in capillary contact with the sample filter and the chromatographic strip, and fluid can flow from the sample filter through the sample pad to the chromatographic strip by capillary or osmotic forces.
  • the method of making a test strip as described herein further comprising the step of: (d) providing a conjugate pad on the chromatographic strip, where the conjugate pad is in capillary contact with the chromatographic strip, and fluid can flow through the conjugate pad to the chromatographic strip by capillary or osmotic forces.
  • the method of making a test strip as described herein further comprising the step of (e) providing a reagent pad on the conjugate pad, where the reagent pad is in capillary contact with the conjugate pad and allows the flow of fluid from the reagent pad to the conjugate pad.
  • the method of making a test strip as described herein further comprising the step of (f) providing a selective membrane between the sample filter and the chromatographic strip, where the selective membrane is in capillary contact with the sample filter and the chromatographic strip and allows the flow of fluid from the sample filter to the chromatographic strip.
  • a method of separating cells from fluid in a sample for conduct of a lateral flow assay for detection of an analyte in the sample comprising the steps of: (a) providing a test strip as described herein; and (b) applying the sample on the sample filter.
  • a method of conducting a lateral flow assay for detection of an analyte in a sample that contains cells and fluid comprising the steps of: (a) providing a test strip as described herein; (b) applying the sample on the sample filter; (c) allowing flow of fluid from the sample filter to the chromatographic strip and towards the second end of the chromatographic strip; (d) applying a buffer to release the conjugate in the conjugate pad;
  • FIG. 1 is a side view of one embodiment of the test strip of the present invention.
  • FIG. 2 is a top view of one embodiment of the test strip of the present invention showing placements of the components of an immunoassay for detection of an analyte in a sample.
  • FIG. 3 is a top view of one embodiment of the test strip of the present invention showing the lateral flow of fluid.
  • FIG. 4 is a side view of another embodiment of the test strip of the present invention.
  • DETAILED DESCRIPTION OF THE INVENTION It has been discovered that the test strip of the present invention can efficiently and effectively separate whole cells from fluid in a sample and can be used to detect an analyte in the sample qualitatively and quantitatively.
  • the test strip of the present invention is commercially usable as a point of care diagnostic (e.g., in a doctor's office or clinic) device.
  • the devices and methods described herein are useful, for example, for the detection of infectious agents, including HIV and HCV as well as other molecules including, for example, deoxypyrodinoline, human serum albumin, drugs of abuse, protein markers such as prostate specific antigen, kidney disease proteins such as lactate dehydrogenate, N-acetyl-.beta.-D-glucosamme, pregnancy or fertility associated hormones such as human chorionic gonadotropin and markers of urinary tract infection.
  • the determination of blood borne analytes such as therapeutic drugs, hormones, cancer markers such as prostate specific antigen, cardiac markers (Troponin I, Troponin T, CKMB) and ⁇ -fetoprotein is particularly suited to the present invention.
  • the sample may be, for example, whole blood.
  • the devices and methods of the present invention is suitable for assaying various body fluids such as urine, saliva, sweat or mucous for the presence of particular analytes, it is particularly suitable for assays in which blood is the test fluid including, for example, a small sample volume when the blood is collected by means such as a finger stick.
  • blood is the test fluid including, for example, a small sample volume when the blood is collected by means such as a finger stick.
  • the singular forms "a,” “an” and “the” include plural references unless the content clearly dictates otherwise.
  • reference to "a sample filter” includes one or more sample filters.
  • FIG. 1 is a side view of one embodiment of the test strip of the present invention.
  • Port I (1) is for application of sample onto sample filter (2), which lies on top of sample pad (3) and, optionally, an additional membrane (4) which may be a selective membrane.
  • the sample filter can be made of any suitable material, for example, a hydrophobic material capable of filtering cells (e.g., blood cells) from fluids.
  • filters or membranes can be adapted for use in the devices and methods as described herein, for example filters such as glass microfiber filters (Whatman, Kent, UK or Millipore), PlasmaSep® (Whatman) and/or C/S membrane, C/Q membranes, S/G membranes and others available from Spectral Diagnostics.
  • the sample filter comprises one or more S/G membranes from Spectral Diagnostics USA, Whitestone, VA, USA. Selection of a sample filter can be made using the teachings described herein, for example to achieve the desired flow rate and/or separation capabilities.
  • the sample application zone can be either hydrophobic or hydrophilic material. In certain embodiments, the sample application zone is hydrophilic to facilitate absorption of the sample into the test strip system. More than one sample filter may be used in any of the devices described herein.
  • the selective membrane (4) may sit on a chromatographic strip (9), which is optionally supported by a multi-layered backing pad (10) that may contain an adhesive layer (11) and a plastic backing (12) for the adhesive layer (11).
  • the backing is a hydrophobic, non-porous material such as polystyrene, polyethylene, polypropylene or other nonbibulous hydrophobic material upon which are placed the absorbent portions of the device.
  • suitable hydrophobic materials include polytetrafluoroethylene and materials that are surface treated with hydrophobic materials such as perfluoroethylene and silanizing agents.
  • FIG. 1 is an absorbent pad (5). Absorbent pad (5) is close to Port I
  • the absorbent pad is preferably hydrophilic and can be derived from any number of materials, including but not limited to cellulose, desiccant treated cellulose and surfactant treated porous polymers. Commercially available materials, such as those available from Whatman, may be used in the devices and methods described herein.
  • FIG. 2 is a top view of one embodiment of the test strip of the present invention showing placement of the components of an exemplary immunoassay for detection of an analyte in a sample. Shown in FIG.
  • absorbent pad (5) from right to left are: absorbent pad (5); Port I (1) where a sample (13) is preferably placed; a capture band (14) for capturing the analyte in the sample, on one or both sides of which are optionally control lines (15), for example for the placement of positive and/or negative controls.
  • control lines (15) To the left of the control lines (15) is Port 2 (6) and the conjugate pad (16) containing, for example, gold conjugated antibody or antigen.
  • the conjugate pad may be hydrophobic or hydrophilic, for example an absorbent, porous material such as glass fiber, polyester or other woven or non-woven synthetic material through which the fluid test sample can flow and may contain one or more mobile conjugate of one or more labeled specific binding partners.
  • the specific binding partner for example an antibody, can be labeled with detectable label such as, for example, an enzyme, fluorofor, radio active isotope or a direct particulate label such as gold particles or colored latex particles.
  • FIG. 3 is a top view of one exemplary embodiment of a test strip according to the present invention showing the direction (17) of the lateral flow of fluid from the sample (13) and the direction (18) of the lateral flow of the conjugate (16) from the conjugate pad (8).
  • FIG. 4 is a side view of another embodiment of the test strip of the present invention.
  • a sample filter (2) is shown placed over the conjugate pad (8), and the conjugate pad (8) is shown placed over the chromatographic strip (9), which optionally may have a backing (19), and adhesive layer (11) and a plastic backing (12) for the adhesive layer (11).
  • the absorbent pad (5) is shown placed at the opposite end of the chromatographic strip (9).
  • the chromatographic strip is between about .1 cm and 5 cm in length (or any value therebetween), preferably between about .5 cm and 2.5 cm (or any value therebetween), and even more preferably about 1 cm in length.
  • the components of the strip will be sized accordingly, for example, in a 1 cm chromatographic strip, the sample filter can be between about 5 to 10 mm in width (or any value therebetween) and 10 to 20 mm in length (or any value therebetween).
  • any of the test strips described herein can be made by providing a chromatographic strip having a first end and a second end; and providing a sample filter having an upper surface and a lower surface, such that the lower surface of the sample filter is in capillary contact with the chromatographic strip and the sample filter is (i) capable of separating cells in a sample from fluid in the sample; (ii) allows the fluid to pass through to the chromatographic strip and (iii) facilitates lateral flow of fluid towards the second end of the chromatographic strip.
  • a sample pad can be placed, for example, between the sample filter and the chromatographic strip, preferably such that the sample pad is in capillary contact with the sample filter and the chromatographic strip, and fluid flows from the sample filter through the sample pad to the chromatographic strip by capillary or osmotic forces.
  • a conjugate pad may also be provided, generally on the chromatographic strip, such that the conjugate pad is in capillary contact with the chromatographic strip, and fluid flows through the conjugate pad to the chromatographic strip by capillary or osmotic forces.
  • a reagent pad may also be provided, for example, on the conjugate pad, such that the reagent pad is in capillary contact with the conjugate pad and allows the flow of fluid from the reagent pad to the conjugate pad.
  • a selective membrane may be provided, for example between the sample filter and the chromatographic strip, such that the selective membrane is in capillary contact with the sample filter and the chromatographic strip and allows the flow of fluid from the sample filter to the chromatographic strip.
  • test strips for example to separate cells from fluid in a sample for conduct of a lateral flow assay for detection of an analyte in the sample.
  • a sample e.g., one containing fluid and cells
  • the strip separates the cells from the fluid in the sample, for instance by allowing the flow of fluid from the sample filter to the chromatographic strip and towards the second end of the chromatographic strip; applying a buffer to release the conjugate in the conjugate pad; allowing the flow of the conjugate towards the analyte in the sample to form a complex; and detecting presence of the complex.
  • quantifying amount of complex formed is applied to any of the test strips described herein and the strip separates the cells from the fluid in the sample, for instance by allowing the flow of fluid from the sample filter to the chromatographic strip and towards the second end of the chromatographic strip; applying a buffer to release the conjugate in the conjugate pad; allowing the flow of the conjugate towards the analyte in the sample to form a complex; and detecting presence of
  • the lateral flow assay of the present invention can be performed, for example, as follows: (1) Serum or plasma is obtained from a blood sample added into Port 1, by application of the sample to the sample filter.
  • This membrane typically contains pores (e.g., about 5 microns or less) that allow liquid to pass through, while retaining blood cells (e.g., about 6 microns), either directly onto the chromatographic strip or through a sample pad.
  • the membrane is preferably an S/G membrane (Spectral Diagnostics).
  • the chromatographic strip is a nitrocellulose immunochromatographic test strip from Millipore Corporation
  • the sample filter was made of a blood cell/plasma separation membrane S/G. This sample filter was obtamed from Spectral Diagnostics Inc. (135-2 The West Mall, Toronto, Ontario M9C 1C2, Canada), and has been described in van Oudheusden, A.P.M. and Roesink, H.D.W., Ann. Clin. Biochem. 28:55-59 (1991); and U.S. Patent No. 5,240,862 ("the '862 patent”), issued August 31, 1993 to assignee X-Flor B.V. and Primecare B.V., entitled "Process and device for the separation of a body fluid from particulate materials.”
  • Other components used are conventional in the industry and can be ordered from any suitable vendor. For example, colloidal gold can be ordered from British BioCell International (Golden Gate, Ty Glas Avenue, Edinburgh CF45DX, Wales, United Kingdom).
  • sample pad and buffer pad were made of a hydrophilic material, Cytosep, which was obtamed from Pall Specialty Materials.
  • the conjugate pad was made from conjugate release pads, a glass, hydrophobic material made by Whatman Inc. (401 West Morgan road, Ann Arbor, MI 48108-9109, U.S.A.) and obtained from Pall Specialty materials.
  • the absorbent was made of a hydrophilic material obtained from Whatman Inc.
  • the sample filter of Example 1 and the conjugate pad, respectively was each placed directly on top of the nitrocellulose chromatographic membrane, and another sample filter was placed directly on the conjugate pad, all in a configuration as shown in FIG. 1 but without the intervening sample pad, selective membrane, and buffer pad.
  • whole blood was applied to the sample filter in both positions, and the assay was allowed to run its course.
  • Plasma or serum separation was similarly effective and efficient, with the sample fluid flowing into the reaction region, that is, the capture line, in about 90 to 150 seconds, for a chromatographic strip that is 1 cm in length.
  • a sample pad was added under the sample filter and a buffer release pad was added above the conjugate pad.
  • Plasma or serum separation was similarly effective and efficient, with the sample fluid flowing into the reaction region, that is, the capture line, in about 90 to 150 seconds, for a chromatographic strip that is 1 cm in length.
  • blood samples with or without anti-coagulant reagents were applied on the sample filter of Example 1.
  • Plasma or serum separation was similarly effective and efficient, with the sample fluid flowing into the reaction region, that is, the capture line, in about 90 to 150 seconds, for a chromatographic strip that is 1 cm in length.
  • blood sample did not contain anti-coagulant, it was not necessary to pre- treat the sample filter with anti-coagulant. In fact, pre-treatment of sample filter with anti-coagulant damaged the sample filter, causing leakage of blood cells.
  • the use of a single layer of sample filter was compared with the use of 2 layers of sample filters.
  • the use of a single layer of sample filter was found to produce a faster flow rate than the use of two sample filters together.
  • the size of the sample filter was varied to optimize the flow rate.
  • the optimal size found was 7 mm (width) by 13 mm (length). Relatively, the larger the size of the sample filter, the shorter the flow time. ⁇
  • EXAMPLE 7 hi this example, buffer (50 to 150 microliter) was added about 30 to 60 seconds after a blood sample was applied to the sample filter.
  • the flow time that is, the time from application of sample to time for fluid to reach the capture line, decreased and the background signal was reduced.
  • An EIA anti-HIV assay confirmed patient blood specimen was collected with anticoagulant reagent. The plasma was collected from an aliquot of the blood sample. 100 microlitres of blood and 50 microliters of plasma were applied on Port 1 of an anti-HIV assay strip. 50 microliter of buffer was added onto Port 1 two minutes after blood sample was applied. After about 20 minutes incubation time, the ReLIA instrument scanned and read the densities generated by the capture bands. The CV% of S/CO was 7.8%.

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CA2452948A CA2452948C (en) 2001-07-18 2002-07-18 A test strip for a lateral flow assay for a sample containing whole cells
EP02768331A EP1417491A4 (en) 2001-07-18 2002-07-18 TEST STRIP FOR SIDE FLOW ASSAY OF A SAMPLE CONTAINING WHOLE CELLS
JP2003514229A JP2004538453A (ja) 2001-07-18 2002-07-18 全細胞を含有するサンプルに対するラテラルフローアッセイのための試験片
AU2002330899A AU2002330899B2 (en) 2001-07-18 2002-07-18 Test strip for a lateral flow assay
US12/580,981 US20100092945A1 (en) 2001-07-18 2009-10-16 Test strip for a lateral flow assay for a sample containing whole cells

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JP2004538453A (ja) 2004-12-24
CA2452948C (en) 2010-09-21
US20030032196A1 (en) 2003-02-13
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US7605004B2 (en) 2009-10-20
CA2452948A1 (en) 2003-01-30

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