Immunoassay controls
First Claim
1. A test strip for immunoassay of at least one biological analyte in a sample comprising, in order of sample migration, a sample pad, a conjugate pad, a membrane containing a test site wherein the presence of said analyte in said sample is indicated by absence of color formation at said test site, said strip comprising a mobile positive control analyte immunologically distinct from said biological analyte in said sample pad, a labeled antibody specific to said control analyte in said conjugate pad, a labeled antibody specific to at least one of said biological analyte in said conjugate pad, an immobile control analyte at a positive control site in said membrane, and an immobile biological analyte at said test site in said membrane, said test strip indicating immunoassay function by absence of color formation at said control site, and said test strip indicating presence of said biological analyte at said test site by the absence of color formation at said test site.
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Accused Products
Abstract
A device and method for performing a rapid immunoassay for a biological analyte containing a positive control analyte which is concurrently tested using the same device and immunochemical reaction as the biological analyte. The positive control analyte is non-crossreactive with the biological analyte to be detected and may be an immunogen or a hapten. The device and method permit operators of the test device, particularly non-laboratory professionals, to determine that an assay is performed correctly and that the device is functioning properly, thereby allowing the operator to have confidence in the accuracy of either a positive or negative result. This is particularly important when a positive result is indicated by the absence of color at a test site, which is counterintuitive with many operators and which frequently occurs with a competitive immunoassay.
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Citations
11 Claims
- 1. A test strip for immunoassay of at least one biological analyte in a sample comprising, in order of sample migration, a sample pad, a conjugate pad, a membrane containing a test site wherein the presence of said analyte in said sample is indicated by absence of color formation at said test site, said strip comprising a mobile positive control analyte immunologically distinct from said biological analyte in said sample pad, a labeled antibody specific to said control analyte in said conjugate pad, a labeled antibody specific to at least one of said biological analyte in said conjugate pad, an immobile control analyte at a positive control site in said membrane, and an immobile biological analyte at said test site in said membrane, said test strip indicating immunoassay function by absence of color formation at said control site, and said test strip indicating presence of said biological analyte at said test site by the absence of color formation at said test site.
- 8. A test strip for concurrent immunoassay of a biological analyte in a sample and a control analyte by competitive immunoassay, said test strip comprising a sample pad comprising a mobilizable control analyte immunologically distinct from said biological analyte, a conjugate pad comprising a mobilizable labeled antibody to said control analyte and a mobilizable labeled antibody to said biological analyte, and a downstream membrane comprising a discrete region of immobilizable control analyte and a discrete region of immobilized biological analyte.
Specification