Cholesterol Threshold Assay

Period of Performance: 08/01/1993 - 07/31/1994


Phase 2 SBIR

Recipient Firm

Micronix, Inc.
Carmel, IN 46032
Principal Investigator


DESCRIPTION: (Adapted from the investigator's abstract.) Proposed is the development of a test strip method for blood cholesterol. Plasma is separated on the strip from cells and absorbed into a reagent impregnated plasma recipient member (U.S. Patent 4,883,764).Cholesterol is quantified by a unique and innovative "Threshold" assay of hydrogen peroxide, generated by cholesterol esterase and oxidase enzymes. The threshold amounts of peroxide equivalent to the NIH recommended cholesterol cutpoints are reacted in a colorless "Scavenger", the above threshold amounts in a highly sensitive "Signal" reaction. This eliminates color background and greatly enhances visual interpretation. Obviating the use of instruments, the method also reduces costs and increases test throughput. The proposed device comprises two reagent pads, one generating color at cholesterol concentrations of 200 mg/dL and above, the other at cholesterol concentrations of 240 mg/dL and above. Lack of color on both pads indicated "desirable", color on one "borderline-high", and color on both pads "high" blood cholesterols. Thus, the device reflects and supports the guidelines of the NIH National Cholesterol Education Program for patient identification and management by consensus derived cardiovascular risk category. The product is targeted for physician office, screening and self-testing markets. Viability of the concept and product feasibility have been demonstrated.