Test device and method of assaying for fructosamines

Chemistry: analytical and immunological testing – Peptide – protein or amino acid – Glycoproteins

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436 95, 436111, 436169, 436903, 436904, 422 56, G01N 3300, G01N 3348, G01N 3349

Patent

active

049563017

ABSTRACT:
A new and improved test device and method of determining the presence and concentration of fructosamines in a test sample. The test device includes a test pad comprising a carrier matrix incorporating an indicator reagent composition capable of interacting with fructosamines to produce a detectable or measurable response. The carrier matrix of the device includes a bibulous matrix, such as filter paper, or a nonbibulous matrix, such as a polymeric film. In addition, a new and improved indicator reagent composition comprising a dye, such as tetrazolium violet; a suitable buffer; and an accelerator compound is incorporated into the carrier matrix to provide a test pad demonstrating sufficient color resolution and having sufficient sensitivity to fructosamines in a test sample. Therefore, a fast, more accurate and trustworthy fructosamine assay of a liquid test sample, such as whole blood or serum, is achieved. The improved method of determining the presence or concentration of fructosamines in a liquid test sample is especially useful in the diagnosis and treatment of diabetes mellitus.

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"Fructosamine: A New Approach to the Estimation of Serum Glycoprotein, an Index of Diabetic Control," Johnson et al., Clin. Chim. Acta, 127(1), 1983, pp. 87-95.

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