Multilayer reagent test strips and methods for using the same to quantify glycated protein in a physiological sample

Abstract

Multilayer reagent test strips for quantitating glycated protein in a fluid sample, as well as methods for using the same, are provided. The subject multilayer test strips include at least a filter layer, a proteinase layer and a ketoamine oxidase signal producing and fluid flow control system layer. In using the subject test strips, a fluid sample is applied to the test strip and a signal is generated that can be employed to quantitate the glycated protein level in the sample. The quantitated glycated protein level can then be employed to determine the amount of glycated protein in the fluid sample. Also provided are kits and systems that include the subject test strips and find use in practicing the subject methods. The subject compositions and methods find use in glycated protein monitoring applications, among other utilities.

Description

FIELD OF THE INVENTION [0001] The field of this invention is analyte detection, particularly glycated protein detection. BACKGROUND OF THE INVENTION [0002] Individuals suffering from diabetes mellitus have an abnormally high blood sugar level generally because the pancreas does not secrete sufficient amounts of the active hormone insulin into the bloodstream to regulate carbohydrate metabolism. If an abnormally high blood sugar level, known as a hyperglycemic condition, is allowed to continue for prolonged periods, the individual will suffer from the chronic complications of diabetes, including retinopathy, nephropathy, neuropathy and cardiovascular disease. Studies indicate that diabetic patients who are able to maintain near normal glycemic control greatly reduce the likelihood of these dire complications. Therefore, several tests have been developed to measure and control glycemic condition. [0003] One common medical test to control glycemic condition is the direct measurement of...

AI Technical Summary

Problems solved by technology

Individuals suffering from diabetes mellitus have an abnormally high blood sugar level generally because the pancreas does not secrete sufficient amounts of the active hormone insulin into the bloodstream to regulate carbohydrate metabolism.

While this assay provides accurate results, it is performed in a clinical lab by a trained technician with a sophisticated instrument, and is therefore not suitable for home or physician office use.

However, measurements provided by the test strips described herein tend to be inaccurate, as substances in the fluid sample other than the fructosamine analyte also react with the signal producing system and affect the signal generated thereby, leading to inaccuracies in the ultimate fructosamine quantification achieved with such test strips.

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