Quantitative analyte assay device and method
AssigneeAssurance LLC
InventorJin Po LEE
Life of this patent
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Abstract
The present invention related to a quantitative assay device and a method for the determination of an analyte, based on a test strip, which contains a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane, wherein the test membrane contains two bands having deposited on there high and low concentrations of different calibrator agents and a test band capable of reacting with conjugated analyte complexes giving rise to a measurable signal.
Claims20
An assay device for the quantitative determination of an analyte, comprising a test strip containing a porous test membrane allowing for capillary flow of the analyte and complexes of the analyte, a porous upstream membrane in fluid connection with the test membrane and a porous downstream membrane in fluid connection with the test membrane,
- (a) said test membrane containing a test site having immobilized thereon a ligand capable of reacting with the analyte and binding such to the test site, and at least two standard band sites having immobilized thereon known high and low concentrations of at least two different calibrator agents capable of reacting with a label conjugated antibody and binding such to the standard sites,
- (b) said upstream membrane having a site for the application of a sample to be analyzed, and having a site downstream from the sample application site for removably depositing label conjugates capable of reacting with the analyte and at least two label conjugates capable of reacting with the immobilized calibrator agents in the standard bands to provide a known label response in the standards bands, and
- (c) said downstream membrane capable of absorbing said sample and providing the capillary flow for the sample through the upstream and test membrane.
The device of claim 6 wherein the test membrane is microporous nitrocellulose and the upstream membrane is fiberglass.
The method for the quantitative analysis an analyte in a sample comprising
- (a) immobilizing on a microporous test strip in a test band an antibody to the analyte to be established in concentrations adequate to bind to analyte concentrations in the sample,
- (b) immobilizing different calibrator agents on the test strip in at least two standard bands in the amounts necessary which when treated with excess of labeled antibodies to the immobilized calibrator agent result in a measurable response corresponding to different concentration of analyte,
- (c) removably depositing on an additional upstream membrane in contact with the test strip labeled antibodies to the analyte and the calibrator agents
- (d) establishing the curve showing the measurable conjugate response to different analyte concentration,
- (e) adding a sample suspected of containing the analyte for which the test strip was designed to the assay strip and complexing such to an antibody conjugated to a measurable label and adding measurable labeled antibodies to the calibrator agents to the sample prior to contact with the standard and test bands,
- (f) measuring the label response at the test and standard bands and comparing such to the standard curve of step (d) for the label responses in the standard bands as established in step (b) and
- (g) converting the measured label responses to concentration of analyte in the sample.
Dependencies are inferred from the claim text.