CA2495190A1 - Fluidics-based assay devices - Google Patents

Fluidics-based assay devices Download PDF

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Publication number
CA2495190A1
CA2495190A1 CA002495190A CA2495190A CA2495190A1 CA 2495190 A1 CA2495190 A1 CA 2495190A1 CA 002495190 A CA002495190 A CA 002495190A CA 2495190 A CA2495190 A CA 2495190A CA 2495190 A1 CA2495190 A1 CA 2495190A1
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Canada
Prior art keywords
probes
detection
calibration
separated
intensity
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Granted
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CA002495190A
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French (fr)
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CA2495190C (en
Inventor
Xuedong Song
Rosann Kaylor
Shawn Feaster
Kaiyuan Yang
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Kimberly Clark Worldwide Inc
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Individual
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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
    • 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
    • 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
    • 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
    • B01L3/5027—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502761—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip specially adapted for handling suspended solids or molecules independently from the bulk fluid flow, e.g. for trapping or sorting beads, for physically stretching molecules
    • 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
    • G01N33/54333—Modification of conditions of immunological binding reaction, e.g. use of more than one type of particle, use of chemical agents to improve binding, choice of incubation time or application of magnetic field during binding reaction
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
    • B01L2200/06—Fluid handling related problems
    • B01L2200/0647—Handling flowable solids, e.g. microscopic beads, cells, particles
    • B01L2200/0668—Trapping microscopic beads
    • 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
    • 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
    • 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
    • B01L2400/043—Moving fluids with specific forces or mechanical means specific forces magnetic forces
    • 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
    • B01L2400/06—Valves, specific forms thereof
    • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
    • 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
    • Y10S435/969—Multiple layering of reactants
    • 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
    • Y10T436/10—Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing

Abstract

A fluidics-based assay device for detecting the presence or quantity of an analyte residing in a test sample is provided. The device utilizes 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 fluidics-based assay device for detecting the presence or quantity of an analyte residing in a test sample, said device comprising:
a reaction chamber, said reaction chamber being capable of containing a solution that comprises the test sample, detection probes capable of generating a detection signal, and magnetic calibration probes capable of generating a calibration signal;
a channel in fluid communication with said reaction chamber, said channel defining a detection zone; and a magnetic device positioned adjacent to said detection zone, said magnetic device being capable of separating said detection probes and said calibration probes from said solution;
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, wherein said channel facilitates capillary flow of the test sample.
3. A device as defined in claim 1, further comprising a barrier disposed between said reaction chamber and said channel, said barrier being capable of holding said solution within said reaction chamber for a certain period of time.
4. A device as defined in claim 3, wherein said barrier is capable of being substantially dissolved by said solution.
5. A device as defined in claim 4, wherein said barrier contains a material selected from the group consisting of carbohydrates, salts, and combinations thereof.
6. A device as defined in claim 3, wherein said barrier is capable of physically rupturing after said certain period of time.
7. 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.
8. A device as defined in claim 1, wherein said detection probes are fluorescent non-magnetic compounds.
9. A device as defined in claim 1, wherein said calibration probes are fluorescent magnetic particles.
10. A device as defined in claim 1, wherein said detection probes are capable of binding to the analyte.
11. A device as defined in claim 1, further comprising non-fluorescent magnetic particles.
12. A device as defined in claim 11, wherein said non-fluorescent magnetic particles are capable of binding to the analyte.
13. A device as defined in claim 1, wherein said separated detection probes include complexes formed by said detection probes.
14. A device as defined in claim 1, wherein said separated calibration probes include complexes formed by said calibration probes.
15. 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.
16. A capillary flow assay device for detecting the presence or quantity of an analyte residing in a test sample, said device comprising:
a reaction chamber, said reaction chamber being capable of containing a solution that comprises the test sample, detection probes capable of generating a detection signal, and magnetic calibration probes capable of generating a calibration signal;
a capillary channel in communication with said reaction chamber, said fluidic capillary channel defining a detection zone;
a barrier disposed between said reaction chamber and said capillary channel, said barrier being capable of holding said solution within said reaction chamber for a certain period of time; and a magnetic device positioned adjacent to said detection zone, said magnetic device being capable of separating said detection probes and said calibration probes from said solution;
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.
17. A device as defined in claim 16, wherein said barrier is capable of being substantially dissolved by said solution.
18. A device as defined in claim 17, wherein said barrier contains a material selected from the group consisting of carbohydrates, salts, and combinations thereof.
19. A device as defined in claim 16, wherein said barrier is capable of physically rupturing after said certain period of time.
20. A device as defined in claim 16, wherein said detection probes and said calibration probes are fluorescent compounds.
21. A device as defined in claim 16, wherein said detection probes are fluorescent non-magnetic compounds.
22. A device as defined in claim 16, wherein said calibration probes are fluorescent magnetic particles.
23. A device as defined in claim 16, wherein said separated detection probes include complexes formed by said detection probes.
24. A device as defined in claim 16, wherein said separated calibration probes include complexes formed by said calibration probes.
25. A device as defined in claim 16, 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.
26. A method for detecting the presence or quantity of an analyte residing in a test sample, said method comprising:
i) providing a fluidics-based device, said device comprising:
a) a reaction chamber containing detection probes capable of generating a detection signal and magnetic calibration probes capable of generating a calibration signal;
b) a channel in fluid communication with said reaction chamber that defines a detection zone; and c) a magnetic device positioned adjacent to said detection zone;

ii) applying a test sample containing the analyte to the reaction chamber to form a solution;
iii), allowing said solution to flow from said reaction chamber to said detection zone of said channel;
iv) separating said detection probes and said calibration probes from said solution at said detection zone using said magnetic device;
v) 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;
vi) 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 vii) 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.
27. A method as defined in claim 26, further comprising holding the solution within said reaction chamber for a certain period of time with a barrier that is disposed between said reaction chamber and said channel.
28. A method as defined in claim 26, wherein said detection and calibration probes are fluorescent.
29. A method as defined in claim 26, wherein said detection and calibration probes are chemiluminescent.
30. A method as defined in claim 26, wherein said detection and calibration probes are phosphorescent.
31. A method as defined in claim 26, wherein said detection probes are non-magnetic.
32. A method as defined in claim 26, wherein said separated detection probes include complexes formed by said detection probes.
33. A method as defined in claim 29, wherein said complexes are formed with the analyte.
34. A method as defined in claim 26, wherein said separated calibration probes include complexes formed by said calibration probes.
35. A method as defined in claim 31, wherein said complexes are formed with the analyte.
36. A method as defined in claim 26, wherein said first emission wavelength is different than said second emission wavelength.
37. A method as defined in claim 26, 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.
38. A method as defined in claim 26, wherein said separated detection probes and said separated calibration probes are excited simultaneously.
39. A method as defined in claim 26, wherein said separated detection probes and said separated calibration probes are excited separately.
40. A method as defined in claim 26, wherein the intensity of the detection signal and the calibration signal are measured simultaneously.
41. A method as defined in claim 26, wherein the intensity of the detection signal and the calibration signal are measured separately.
CA2495190A 2002-08-27 2003-08-08 Fluidics-based assay devices Expired - Lifetime CA2495190C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/228,838 US7314763B2 (en) 2002-08-27 2002-08-27 Fluidics-based assay devices
US10/228,838 2002-08-27
PCT/US2003/024871 WO2004021006A1 (en) 2002-08-27 2003-08-08 Fluidics-based assay devices

Publications (2)

Publication Number Publication Date
CA2495190A1 true CA2495190A1 (en) 2004-03-11
CA2495190C CA2495190C (en) 2012-12-18

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US (1) US7314763B2 (en)
EP (1) EP1532451A1 (en)
KR (1) KR100994345B1 (en)
CN (1) CN100365416C (en)
AU (1) AU2003259690A1 (en)
CA (1) CA2495190C (en)
MX (1) MXPA05001678A (en)
TW (1) TWI251080B (en)
WO (1) WO2004021006A1 (en)

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