Method for continuous manufacture of diagnostic test strips

Coating processes – Medical or dental purpose product; parts; subcombinations;... – Analysis – diagnosis – measuring – or testing product

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435 4, 435 71, 435 79, 422 56, 422 57, G01N 33531, B05D 300, C12Q 128, C12Q 154

Patent

active

055477020

ABSTRACT:
A method for making a test strip is described. The test strip is generally a substrate, a layer disposed on the substrate and located near the distal end of the substrate. The layer typically contains a chemical reagent detection system capable of detecting the presence of a predetermined analyte in a sample of biological fluid, wherein the reagent detection system produces a detectable change in the layer in the presence of the analyte. In the method, a length of substrate is provided having a width substantially the dimension of the final length of the test strip being made; on the substrate near one edge thereof is provided a layer of material permeable to biological fluids, the layer having a width sufficient to place thereon a drop of biological fluid for treating; to the layer of permeable material is continuously applied an aqueous solution containing reagent detection chemicals capable of providing a detectable change in the presence of a predetermined analyte, the solution being applied in an amount to substantially saturate the permeable material; the layer of permeable material is dried to contain the reagent detection chemicals within the layer; and the web is cut into predetermined shorter lengths containing a preset number of test strips for further processing.

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