Multizone analytical element having detectable signal concentrating zone
First Claim
1. A multizone test device for the specific binding assay determination of an analyte in a liquid test medium involving binding between (i) the analyte and a labeled or immobilized form of the analyte or of a binding analog thereof, and (ii) an immobilized or labeled form, respectively, of a binding partner of the analyte, the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group which interacts with a detectant composition to produce a detectable signal, the test device comprising, in fluid flow contact,(1) a reagent zone comprising a solid, porous matrix incorporated with a immobilized one of the analyte, analog thereof, or binding partner, and(2) a detection zone comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into such zone and incorporated with an immobilized form of at least one component of a detectant composition.
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Accused Products
Abstract
A multizone test device for the determination of analyte from a liquid test medium upon contact with the liquid test medium and a labeled reagent comprising a chemical group having a detectable chemical property. The test device preferably comprises multilayers including a reagent layer incorporated with an immobilized reagent and a detection layer incorporated with an immobilized form of an interactive detection reagent for the labeled reagent. The immobilized reagent in the reagent layer and the labeled reagent comprise specific binding partners which will bind to each other dependent upon the amount of analyte present. Labeled reagent which does not become bound to the immobilized reagent in the reagent layer migrates into the detection layer and interacts with the immobilized interactive detection reagent therein which results in the localized generation of a detectable reaction product which preferably is also immobilized in the detection zone. As a result, reverse migration of the labeled reagent, and preferably the detectable reaction product from the detection layer is prevented and the detectable chemical property provided by the label of the labeled reagent is localized in the detection layer for the precise measurement thereof and correlation to the amount of analyte in the test medium.
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Citations
29 Claims
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1. A multizone test device for the specific binding assay determination of an analyte in a liquid test medium involving binding between (i) the analyte and a labeled or immobilized form of the analyte or of a binding analog thereof, and (ii) an immobilized or labeled form, respectively, of a binding partner of the analyte, the labeled one of the analyte, analog thereof, or binding partner being a labeled reagent comprising a detectable chemical group which interacts with a detectant composition to produce a detectable signal, the test device comprising, in fluid flow contact,
(1) a reagent zone comprising a solid, porous matrix incorporated with a immobilized one of the analyte, analog thereof, or binding partner, and (2) a detection zone comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into such zone and incorporated with an immobilized form of at least one component of a detectant composition.
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22. A multilayer immunoassay test device for the determination of an analyte in an aqueous liquid medium, which test device provides a detectable optical signal upon contact with aqueous medium containing analyte, the test device comprising, in fluid flow contact and in the following ordered sequence,
(1) a first reagent layer comprising a solid, porous matrix incorporated with a water soluble form of a labeled reagent comprising an antibody, or a fragment thereof, for the analyte and an enzyme that acts on an enzyme substrate to transform it into a procuct which provides the detectable optical signal, (2) a second reagent layer comprising a solid, porous matrix incorporated with an immobilized form of the analyte or a binding analog thereof, (3) a detection layer comprising a solid, porous matrix for receiving and measuring labeled reagent which migrates into such layer and incorporated with an immobilized form of said enzyme substrate, and (4) a support element comprising a solid, nonporous substrate.
Specification