CA2495209A1 - Membrane-based assay devices - Google Patents

Membrane-based assay devices Download PDF

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Publication number
CA2495209A1
CA2495209A1 CA002495209A CA2495209A CA2495209A1 CA 2495209 A1 CA2495209 A1 CA 2495209A1 CA 002495209 A CA002495209 A CA 002495209A CA 2495209 A CA2495209 A CA 2495209A CA 2495209 A1 CA2495209 A1 CA 2495209A1
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probes
detection
calibration
separated
intensity
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French (fr)
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CA2495209C (en
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Xuedong Song
Rosann Kaylor
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Kimberly Clark Worldwide Inc
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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
    • G01N33/54313—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals the carrier being characterised by its particulate form
    • G01N33/54326—Magnetic particles
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/27—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using photo-electric detection ; circuits for computing concentration
    • G01N21/274—Calibration, base line adjustment, drift correction
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6408—Fluorescence; Phosphorescence with measurement of decay time, time resolved fluorescence
    • 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
    • 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
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • 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
    • G01N33/58—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances
    • G01N33/582—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving labelled substances with fluorescent label
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/62—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light
    • G01N21/63—Systems in which the material investigated is excited whereby it emits light or causes a change in wavelength of the incident light optically excited
    • G01N21/64—Fluorescence; Phosphorescence
    • G01N21/6428—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes"
    • G01N2021/6439—Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" with indicators, stains, dyes, tags, labels, marks
    • 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
    • Y10S435/803—Physical recovery methods, e.g. chromatography, grinding
    • 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
    • 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
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S436/00—Chemistry: analytical and immunological testing
    • Y10S436/80—Fluorescent dyes, e.g. rhodamine
    • 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
    • Y10S436/806—Electrical property or magnetic property
    • 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
    • Y10S436/824—Immunological separation techniques
    • 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
    • Y10T436/13—Tracers or tags

Abstract

A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device uses a self-calibrated magnetic binding assay format (e.g., sandwich, competitive, etc.) that includes detection probes capable of generating a detection signal (e.g., fluorescent non-magnetic particles) and calibration probes capable of generating a calibration signal (e.g., fluorescent magnetic particles). The amount of the analyte within the test sample is proportional (e.g., directly or inversely) to the intensity of the detection signal calibrated by the intensity of the calibration signal. It has been discovered that the fluidics-based device of the present invention provides an accurate, inexpensive, and readily controllable method of determining the presence of an analyte in a test sample.

Claims (41)

1. A membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample, said device comprising:
a porous membrane in fluid communication with detection probes capable of generating a detection signal and magnetic calibration probes capable of generating a calibration signal, said porous membrane defining a detection zone;
and a magnetic device positioned adjacent to said detection zone, wherein said magnetic device is capable of separating said detection probes and said calibration probes from a test sample applied to said porous membrane, wherein the amount of the analyte within the test sample is proportional to the intensity of the detection signal generated by said separated detection probes at the detection zone calibrated by the intensity of the calibration signal generated by said separated calibration probes at the detection zone.
2. A device as defined in claim 1, further comprising one or more conjugate pads in fluid communication with said porous membrane, said detection probes and said calibration probes being applied to said one or more conjugate pads.
3. A device as defined in claim 1, wherein said porous membrane is in fluid communication with a sampling pad to which the test sample is applied.
4. A device as defined in claim 1, further comprising a wicking pad in fluid communication with said porous membrane to facilitate the flow of the test sample therethrough.
5. A device as defined in claim 1, wherein said detection probes and said calibration probes are fluorescent compounds, chemiluminescent compounds, phosphorescent compounds, or combinations thereof.
6. A device as defined in claim 1, wherein said detection probes are fluorescent non-magnetic compounds.
7. A device as defined in claim 1, wherein said calibration probes are fluorescent magnetic particles.
8. A device as defined in claim 1, wherein said detection probes are capable of binding to the analyte.
9. A device as defined in claim 1, further comprising non-fluorescent magnetic particles.
10. A device as defined in claim 9, wherein said non-fluorescent magnetic particles are capable of binding to the analyte.
11. A device as defined in claim 1, wherein said separated detection probes include complexes formed by said detection probes.
12. A device as defined in claim 1, wherein said separated calibration probes include complexes formed by said calibration probes.
13. A device as defined in claim 1, wherein the amount of the analyte within the test sample is proportional to the intensity of the detection signal generated by said separated detection probes at said detection zone divided by the intensity of the calibration signal generated by said separated calibration probes at said detection zone.
14. A lateral flow membrane-based assay device for detecting the presence or quantity of an analyte residing in a test sample, said device comprising:
a porous membrane in fluid communication with detection probes capable of generating a detection signal, fluorescent magnetic calibration probes capable of generating a calibration signal, and optionally non-fluorescent magnetic particles, said porous membrane defining a detection zone; and a magnetic device positioned adjacent to said detection zone, wherein said magnetic device is capable of separating said detection probes and said calibration probes from a test sample applied to said porous membrane, wherein the amount of the analyte within the test sample is proportional to the intensity of the detection signal generated by said separated detection probes at the detection zone calibrated by the intensity of the calibration signal generated by said separated calibration probes at the detection zone.
15. A device as defined in claim 14, further comprising one or more conjugate pads in fluid communication with said porous membrane, said detection probes and said calibration probes being applied to said one or more conjugate pads.
16. A device as defined in claim 14, wherein said porous membrane is in fluid communication with a sampling pad to which the test sample is applied.
17. A device as defined in claim 14, further comprising a wicking pad in fluid communication with said porous membrane to facilitate the flow of the test sample therethrough.
18. A device as defined in claim 14, wherein said detection probes are fluorescent non-magnetic compounds.
19. A device as defined in claim 14, wherein said separated detection probes include complexes formed by said detection probes.
20. A device as defined in claim 14, wherein said separated calibration probes include complexes formed by said calibration probes.
21. A device as defined in claim 14, wherein the amount of the analyte within the test sample is proportional to the intensity of the detection signal generated by said separated detection probes at said detection zone divided by the intensity of the calibration signal generated by said separated calibration probes at said detection zone.
22. A method for detecting the presence or quantity of an analyte residing in a test sample, said method comprising:
i) providing a membrane-based device, said device comprising:
a) a porous membrane in fluid communication with detection probes capable of generating a detection signal and magnetic calibration probes capable of generating a calibration signal, said porous membrane defining a detection zone; and b) a magnetic device positioned adjacent to said detection zone;
ii) contacting said detection probes and said calibration probes with the test sample to form a solution;
iii) separating said detection probes and said calibration probes from said solution at said detection zone using said magnetic device;
iv) exciting said separated detection probes and said separated calibration probes, wherein said excitation causes said separated detection probes to emit said detection signal and said separated calibration probes to emit said calibration signal;
v) measuring the intensity of the detection signal at a first emission wavelength and the intensity of the calibration signal at a second emission wavelength; and vi) comparing the intensity of the detection signal to the calibration signal, wherein the amount of the analyte within the test sample is proportional to the intensity of the detection signal calibrated by the intensity of the calibration signal.
23. A method as defined in claim 22, wherein said membrane-based device further comprises one or more conjugate pads in fluid communication with said porous membrane, said detection probes and said calibration probes being applied to said one or more conjugate pads.
24. A method as defined in claim 22, wherein said porous membrane is in fluid communication with a sampling pad to which the test sample is applied.
25. A method as defined in claim 22, further comprising a wicking pad in fluid communication with said porous membrane to facilitate the flow of the test sample therethrough.
26. A method as defined in claim 22, wherein said detection probes are non-magnetic.
27. A method as defined in claim 22, wherein said separated detection probes include complexes formed by said detection probes.
28. A method as defined in claim 27, wherein said complexes are formed with the analyte.
29. A method as defined in claim 22, wherein said separated calibration probes include complexes formed by said calibration probes.
30. A method as defined in claim 28, wherein said complexes are formed with the analyte.
31. A method as defined in claim 22, wherein said first emission wavelength is different than said second emission wavelength.
32. A method as defined in claim 22, further comprising generating a calibration curve by plotting the intensity of the detection signal calibrated by the intensity of the calibration signal for a plurality of predetermined analyte concentrations.
33. A method as defined in claim 22, wherein said separated detection probes and said separated calibration probes are excited simultaneously.
34. A method as defined in claim 22, wherein said separated detection probes and said separated calibration probes are excited separately.
35. A method as defined in claim 22, wherein the intensity of the detection signal and the calibration signal are measured simultaneously.
36. A method as defined in claim 22, wherein the intensity of the detection signal and the calibration signal are measured separately.
37. A method as defined in claim 22, wherein said detection and calibration probes are chemiluminescent.
38. A method as defined in claim 22, wherein said detection and calibration probes are phosphorescent.
39. A method as defined in claim 22, wherein said detection and calibration probes are fluorescent.
40. A method as defined in claim 38, wherein a fluorescence reader is used to measure the intensity of said detection signal and said calibration signal.
41. A method as defined in claim 39, wherein said fluorescence reader uses time-resolved fluorescence spectroscopy to measure said detection and said calibration signals.
CA2495209A 2002-08-27 2003-07-10 Membrane-based assay devices Expired - Lifetime CA2495209C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/228,836 2002-08-27
US10/228,836 US7285424B2 (en) 2002-08-27 2002-08-27 Membrane-based assay devices
PCT/US2003/021522 WO2004021005A1 (en) 2002-08-27 2003-07-10 Flow-through assay with an internal calibration system using___ magnetic particles

Publications (2)

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CA2495209A1 true CA2495209A1 (en) 2004-03-11
CA2495209C CA2495209C (en) 2011-10-25

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US (3) US7285424B2 (en)
EP (1) EP1532450B1 (en)
KR (2) KR20110089194A (en)
CN (1) CN100365417C (en)
AT (1) ATE467835T1 (en)
AU (1) AU2003247957A1 (en)
CA (1) CA2495209C (en)
DE (1) DE60332539D1 (en)
MX (1) MXPA05001681A (en)
TW (1) TW200424521A (en)
WO (1) WO2004021005A1 (en)

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US20080096288A1 (en) 2008-04-24
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US7632653B2 (en) 2009-12-15
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EP1532450B1 (en) 2012-09-05
CA2495209C (en) 2011-10-25
US20040043502A1 (en) 2004-03-04
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AU2003247957A1 (en) 2004-03-19

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