Quality control procedure for membrane flow-through diagnostic a

Chemistry: analytical and immunological testing – Involving an insoluble carrier for immobilizing immunochemicals

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422 56, 422 57, 422 58, 422 99, G01N 33543

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active

060571659

ABSTRACT:
The present invention relates to a flow-through device that has a quality control procedure for a binder used in the test area of an assay device to bind an analyte from a test sample. The invention provides for a method for determining the presence of an analyte in a fluid sample, said method employing an assay test kit including an assay device having a porous membrane having an upper surface and a lower surface, a test area on the upper surface of said membrane, a binder for the analyte attached to said test area; a delivery device comprising a well for receiving the sample, said well having an opening at a lower end thereof, wherein said sample is capable of being delivered through the well to a portion of the test area on the upper surface of said porous membrane of the assay device; a vessel containing a tracer having a tag, wherein said tracer is for application to said portion of the test area whereby the tag of said tracer is detected in said portion of the test area when the analyte is present in the fluid sample; and a vessel containing an analyte positive control sample comprising said analyte which is applied to the test area and said tracer is applied to the test area whereby the tag of said tracer is detected in said test area thus confirming that said analyte is specifically bound by said binder in the test area.

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