Opposable-element chromatographic assay device for detection of analytes in whole blood samples
First Claim
1. A chromatographic assay device for detection of at least one analyte in at least one sample, comprising:
- (a) a first opposable component including;
(i) at least one sample application zone each containing a matrix of a porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; and
(ii) at least one chromatographic medium each having a first end in operable contact with a corresponding sample application zone and a second end, each chromatographic medium including;
(A) a detection zone containing an immobilized first reagent; and
(B) a conjugate zone located between the first end and the detection zone and containing a labeled second reagent in a resolubilizable form; and
(b) a second opposable component including;
(i) at least one applicator each corresponding to a sample application zone for applying a wash liquid; and
(ii) at least one absorber each corresponding to a chromatographic medium;
wherein when the first and second opposable components are brought into opposition, each applicator is in operable contact with the corresponding sample application zone to apply the wash liquid in the applicator to the sample application zone, and each absorber is in operable contact with the second end of the corresponding chromatographic medium.
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Abstract
A chromatographic assay device according to the present invention provides a unidirectional immunoassay for an analyte in a whole blood sample with improved sensitivity and freedom from interference. Such a device comprises: (1) a first opposable component including: (a) a sample application zone containing a matrix of porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; and (b) a chromatographic medium having first and second ends and including: (i) a detection zone having immobilized thereon a first specific binding partner for the analyte; and (ii) a conjugate zone having a labeled second specific binding partner for the analyte in a resolubilizable form; the sample application zone being in operable contact with the first end of the chromatographic medium and the conjugate zone being located closer to the first end of the chromatographic medium than the detection zone; and (2) a second opposable component including: (a) an applicator; and (b) an absorber. In the device, the first and second opposable components are brought into operable contact to cause the applicator to come into operable contact with the sample application zone to apply a wash liquid thereto and cause the absorber to come into operable contact with the second end of the chromatographic medium. Also within the scope of the invention are multiplex devices that can perform more than one assay simultaneously and test kits.
102 Citations
30 Claims
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1. A chromatographic assay device for detection of at least one analyte in at least one sample, comprising:
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(a) a first opposable component including;
(i) at least one sample application zone each containing a matrix of a porous material permeable to the liquid portion of blood but capable of trapping the cellular components of blood; and
(ii) at least one chromatographic medium each having a first end in operable contact with a corresponding sample application zone and a second end, each chromatographic medium including;
(A) a detection zone containing an immobilized first reagent; and
(B) a conjugate zone located between the first end and the detection zone and containing a labeled second reagent in a resolubilizable form; and
(b) a second opposable component including;
(i) at least one applicator each corresponding to a sample application zone for applying a wash liquid; and
(ii) at least one absorber each corresponding to a chromatographic medium;
wherein when the first and second opposable components are brought into opposition, each applicator is in operable contact with the corresponding sample application zone to apply the wash liquid in the applicator to the sample application zone, and each absorber is in operable contact with the second end of the corresponding chromatographic medium. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30)
(C) a validation zone located between the detection zone and the second end and containing an immobilized third reagent, the third reagent binding human antibodies that bind the first or the second reagent.
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16. The chromatographic assay device of claim 15, wherein each chromatographic medium further includes:
(D) a capture zone located between the conjugate zone and the first end and containing a fourth reagent, the fourth reagent binding human antibodies that bind the first or the second reagent.
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17. The chromatographic assay device of claim 15, wherein each sample application zone contains a fourth reagent, the fourth reagent binding human antibodies that bind the first or the second reagent.
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18. The chromatographic assay device of claim 15, wherein the first opposable component further includes:
(iii) at least one conductor each in operable contact with a corresponding sample application zone and with the first end of a corresponding chromatographic medium, each conductor containing a fourth reagent, the fourth reagent binding human antibodies that bind the first or the second reagent.
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19. The chromatographic assay device of claim 1, wherein each sample application zone is in direct contact with the first end of the corresponding chromatographic medium.
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20. The chromatographic assay device of claim 1, further comprising at least one barrier each located between a sample application zone and the corresponding applicator for preventing fluid flow therebetween.
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21. The chromatographic assay device of claim 1 wherein each matrix contains a detergent and a chelating agent.
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22. The chromatographic assay device of claim 21 wherein the detergent is selected from the group consisting of a polyoxyethylene sorbitan monolaurate, a poloxyethylene sorbitan monooleate, a polyoxyethylene sorbitan monopalmitate, a polyoxyethylene sorbitan monostearate, a polyoxyethylene sorbitan trioleate, a polyethylene glycol fatty alcohol ether, a polyoxyethylene fatty acid ester, t-octylphenoxypolyethoxyethanol and a polyoxyethylene ether.
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23. The chromatographic assay device of claim 22 wherein the detergent is a polyoxethylene sorbitan monolaurate or t-octylphenoxypolyethoxyethanol.
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24. The chromatographic assay device of claim 21 wherein the chelating agent is selected from the group consisting of EDTA and EGTA.
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25. The chromatographic assay device of claim 24 wherein the chelating agent is EDTA.
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26. The chromatographic assay device of claim 1 wherein each chromatographic medium further includes a control zone separated from the detection zone.
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27. The chromatographic assay device of claim 26 wherein the control zone is located between the detection zone and the second end of the chromatographic medium.
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28. The chromatographic assay device of claim 26 wherein the control zone includes an analyte or an analyte analogue immobilized thereto.
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29. The chromatographic assay device of claim 26 wherein the control zone includes an immobilized fifth reagent specifically binding the second reagent but not binding the analyte bound by the second reagent.
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30. A test kit comprising:
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(a) the chromatographic assay device of claim 1; and
(b) a wash liquid packaged in a separate container for application to the applicators of the chromatographic assay device.
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Specification