CHOLESTEROL THRESHOLD ASSAY

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 11327
Amount: $417,683.00
Phase: Phase II
Program: SBIR
Awards Year: 1992
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
10930 Braewick Dr, Carmel, IN, 46032
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 () -
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THIS PROJECT WILL DEVELOP A BLOOD-TEST STRIP FOR CHOLESTEROL. PLASMA IS SEPARATED ON THE STRIP FROM CELLS BY A PATENTED FILTRATION PROCESS THROUGH A GLASS FIBER FLEECE, COLLECTING THE PLASMA ON A DETACHABLE RECIPIENT MEMBER AND ELUTING IT INTO A LIQUID REAGENT. CHOLESTEROL ESTERASE (CHE) AND OXIDASE (CHOD) ARE INCORPORATED IN DRY FORM ON THE STRIP. QUANTITATION IS BASED ON A THRESHOLD ASSAY FOR PEROXIDE GENERATED BY CHE AND CHOD. THE ASSAY COMPRISES A SCAVENGER AND A SIGNAL REACTION. THE BELOW-THRESHOLD AMOUNT OF PEROXIDE, EQUIVALENT TO THE 200 MG/DL CHOLESTEROL CUTOFF RECENTLY SUGGESTED BY THE NATIONAL HEART, LUNG, AND BLOOD INSTITUTE, IS REACTED IN THESCAVENGER, THE ABOVE-THRESHOLD AMOUNT IN THE SIGNAL REACTION. THUS, BY ELIMINATION OF LARGE COLOR BACKGROUNDS AND BY CHOOSING HIGHLY SENSITIVE SIGNAL REACTIONS, VISUAL INTERPRETATION IS GREATLY ENHANCED. THE DEVICE DOES NOT REQUIRE AN INSTRUMENT, MAKING IT ECONOMICAL AND FAST FOR MASS SCREENINGS AND SELF-MONITORING. FEASIBILITY OF THE TEST PRINCIPLE HAS BEEN DEMONSTRATED FOR PEROXIDE AND CHOLESTEROL FROM SERUM. THIS RESEARCH WILL INCLUDE THE FINAL SELECTION OF OPTIMAL PLASMA SEPARATION AND RECIPIENT MEMBER MATERIALS, OPTIMIZATION OF THE REAGENT SYSTEM, AND THE MANUFACTURE OF FUNCTIONAL PROTOTYPE TEST STRIPS CAPABLE OF DIFFERENTIATING CONCENTRATION INTERVALS OF BETWEEN 10 AND 20 MG/DL AROUND THE 200 MG/DL CUTOFF LEVEL.

* Information listed above is at the time of submission. *

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