Assays
First Claim
1. A test device for determination of an analyte in a liquid sample, comprising:
- (a) a nitrocellulose carrier, (b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the nitrocellulose carrier;
(c) a labeled reagent which is freely mobile in the nitrocellulose carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;
(d) a sample receiving member; and
(e) a control zone, disposed on or in the nitrocellulose carrier on a side of the detection zone remote from the sample receiving member, wherein the control zone comprises a control binding reagent which binds the labeled reagent whether or not analyte is present in the sample;
wherein liquid sample applied to the sample receiving member is transported to and then along the length of the nitrocellulose carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample.
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Reexamination
Accused Products
Abstract
An analytical test device useful for example in pregnancy testing, comprises a hollow casing (500) constructed of moisture-impervious solid material, such as plastics materials, containing a dry porous carrier (510) which communicates indirectly with the exterior of the casing via a bibulous sample receiving member (506) which protrudes from the casing such that a liquid test sample can be applied to the receiving member and permeate therefrom to the porous carrier, the carrier containing in a first zone a labelled specific binding reagent is freely mobile within the porous carrier when in the moist state, and in a second zone spatially distinct from the first zone unlabelled specific binding reagent for the same analyte which unlabelled reagent is permanently immobilised on the carrier material and is therefore not mobile in the moist state, the two zones being arranged such that liquid sample applied to the porous carrier can permeate via the first zone into the second zone, and the device incorporating means, such as an aperture (508) in the casing, enabling the extent (if any) to which the labelled reagent becomes bound in the second zone to be observed. Preferably the device includes a removable cap for the protruding bibulous member.
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Citations
38 Claims
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1. A test device for determination of an analyte in a liquid sample, comprising:
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(a) a nitrocellulose carrier, (b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the nitrocellulose carrier;
(c) a labeled reagent which is freely mobile in the nitrocellulose carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;
(d) a sample receiving member; and
(e) a control zone, disposed on or in the nitrocellulose carrier on a side of the detection zone remote from the sample receiving member, wherein the control zone comprises a control binding reagent which binds the labeled reagent whether or not analyte is present in the sample;
wherein liquid sample applied to the sample receiving member is transported to and then along the length of the nitrocellulose carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample. - 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)
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24. A test device for determination of an analyte in a liquid sample, comprising:
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(a) a nitrocellulose carrier, (b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the nitrocellulose carrier;
(c) a labeled reagent which is freely mobile in the nitrocellulose carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;
(d) a sample receiving member; and
(e) a hollow casing formed from a moisture impervious material, wherein nitrocellulose carrier is disposed within the hollow casing, the sample receiving member connects the interior of the hollow casing to the exterior of the hollow casing;
wherein liquid sample applied to the sample receiving member is transported to and then along the length of the nitrocellulose carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample.
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25. A test device for determination of an analyte in a liquid sample, comprising:
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(a) a carrier through which the liquid sample can flow;
(b) a binding reagent effective to capture analyte, when present, in a defined detection zone of the carrier;
(c) a labeled reagent which in freely mobile in the carrier in the presence of the liquid sample, said labeled reagent being selected such that it is captured in the detection zone when analyte is present in the liquid sample;
(d) a sample receiving member; and
(e) a control zone, disposed on or in the nitrocellulose carrier on a side of the detection zone remote from the sample receiving member, wherein the control zone comprises a control binding reagent which binds the labeled reagent whether or not analyte is present in the sample, wherein liquid sample applied to the sample receiving member is transported to and then along the length of the carrier to pass through the detection zone, and wherein the detection of labeled reagent in the detection zone is indicative of the presence of analyte in the liquid sample. - View Dependent Claims (33, 34, 35, 36, 37, 38)
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- 26. The device of clam 25, wherein the labeled reagent is disposed in a reagent zone on or in the carrier, said reagent zone being spatially separate from the detection zone, and disposed between the sample receiving member and the detection zone.
Specification