SBIR/STTR Research Award

CHOLESTEROL THRESHOLD ASSAY

Award identifier a93457259a34664c4c843abe3cdb0552ac8e756a3726a335d5ad6283a8139366Awarding agency Department of Health and Human Services

Award amount

$417,683

Program and phase

SBIR · Phase II

Award year

1992

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Award details

Awarding agency
Department of Health and Human Services
Branch
Not reported
Recipient company
MICRONIX, INC.
Proposal award date
Not reported
Contract end date
Not reported
UEI
Not reported
Solicitation number
Not reported
Topic code
Not reported

Research 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.

Technology keywords

Not reported

Agency intelligence

Department of Health and Human Services

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