Assays
First Claim
1. A method for making a device for analyzing an aqueous liquid sample for the presence of an analyte, comprising:
- (a) preparing a reagent sheet comprising a sheet of a macroporous material and a direct particulate labeling reagent, the direct particulate labeling reagent comprising a binding portion capable of binding the analyte;
(b) subdividing the reagent sheet into multiple individual macroporous bodies comprising the labeling reagent;
(c) drying the direct particulate labeling reagent; and
(d) positioning a porous sample receiving member, one of the macroporous bodies, a porous carrier having a detection zone, and a capture reagent immobilized in the detection zone in moisture conductive contact such that a liquid sample received by the sample receiving member permeates by capillary action through the sample receiving member and subsequently passes into the macroporous body, permeates by capillary action through the macroporous body and mobilizes the dried particulate labeling reagent thereof and, subsequently, liquid comprising mobilized labeling reagent passes into the porous carrier at a location spaced apart from the detection zone and permeates by capillary action along the porous carrier to the detection zone, the capture reagent immobilized in the detection zone being effective to capture labeling reagent and analyte in the detection zone when the analyte is present in a sample received by the porous sample receiving member.
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Accused Products
Abstract
An analytical test device incorporating a dry porous carrier to which a liquid sample, eg. urine, suspected of containing an analyte such as HCG or LH can be applied indirectly, the device also incorporating a labelled specific binding reagent which is freely mobile in the porous carrier when in the moist state, and an unlabelled specific binding reagent which is permanently immobilised in a detection zone on the carrier material, the labelled and unlabelled specific binding reagents being capable of participating in either a sandwich reaction or a competition reaction in the presence of the analyte, in which prior to the application to the device of a liquid sample suspected of containing the analyte, the labelled specific binding reagent is retained in the dry state in a macroporous body, eg. of plastics material having a pore size of 10 microns or greater, through which the applied liquid sample must pass en route to the porous carrier material, the labelled specific binding reagent being freely soluble or dispersible in any liquid sample which enters the macroporous body.
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Citations
16 Claims
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1. A method for making a device for analyzing an aqueous liquid sample for the presence of an analyte, comprising:
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(a) preparing a reagent sheet comprising a sheet of a macroporous material and a direct particulate labeling reagent, the direct particulate labeling reagent comprising a binding portion capable of binding the analyte; (b) subdividing the reagent sheet into multiple individual macroporous bodies comprising the labeling reagent; (c) drying the direct particulate labeling reagent; and (d) positioning a porous sample receiving member, one of the macroporous bodies, a porous carrier having a detection zone, and a capture reagent immobilized in the detection zone in moisture conductive contact such that a liquid sample received by the sample receiving member permeates by capillary action through the sample receiving member and subsequently passes into the macroporous body, permeates by capillary action through the macroporous body and mobilizes the dried particulate labeling reagent thereof and, subsequently, liquid comprising mobilized labeling reagent passes into the porous carrier at a location spaced apart from the detection zone and permeates by capillary action along the porous carrier to the detection zone, the capture reagent immobilized in the detection zone being effective to capture labeling reagent and analyte in the detection zone when the analyte is present in a sample received by the porous sample receiving member. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method for making a device for analyzing an aqueous liquid sample for the presence of human chronic gonadotrophin (hCG), comprising:
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(a) preparing a reagent sheet comprising a sheet of a macroporous material and a direct particulate labeling reagent the direct particulate labeling reagent comprising a binding portion capable of binding hCG; (b) subdividing the reagent sheet into multiple individual macroporous bodies comprising the labeling reagent; (c) drying the direct particulate labeling reagent; and (d) positioning a porous sample receiving member, one of the macroporous bodies, a nitrocellulose porous carrier having a detection zone, and a capture reagent immobilized in the detection zone such that a liquid sample received by the sample receiving member permeates by capillary action through the sample receiving member and subsequently passes into the macroporous body, permeates by capillary action through the macroporous body and mobilizes the dried particulate labeling reagent thereof and, subsequently, liquid comprising mobilized labeling reagent passes into the porous carrier at a location spaced apart from the detection zone and permeates by capillary action along the porous carrier to the detection zone, the capture reagent immobilized in the detection zone being effective to capture labeling reagent and hCG in the detection zone when hCG is present in a sample received by the porous sample receiving member. - View Dependent Claims (16)
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Specification