Accession Number:

ADB215485

Title:

Simple Semi-Quantitative Device for Hormones in Body Fluids. Phase 1

Descriptive Note:

Final rept. 15 Mar-14 Sep 1996

Corporate Author:

EMERALD DIAGNOSTICS INC EUGENE OR

Report Date:

1996-10-01

Pagination or Media Count:

34.0

Abstract:

Efforts to pinpoint phases of hormonal cycles through daily blood sample laboratory analyses have proven excessively expensive and impractical by routine laboratory methods. An attractive alternative is to employ immunochemical test strips to indicate critical ranges of key hormones and metabolites in easily obtained fluids such as urine since such techniques offer, in principle, rapid test results at modest cost. Such test strips require no instrumentation and minimal training of the user. During the Phase I studies, Emerald Diagnostics demonstrated technical feasibility of an enzyme amplified immunochromatography EAIC test strip platform for urine. This technology employed the enzymes glucose oxidase and horseradish peroxidase to generate color at the site of a specific antibody-mediated binding event. A sensitive competitive immunoassay was developed for the progesterone metabolite pregnanediol 3 -glucuronide with a sensitivity of 1 ugml and a clinically useful dynamic range of 1 - 20 ugml. Feasibility was also demonstrated for a biotinstreptavidin model with sensitivity of 20 ugml of biotin and a fluoresceinanti-fluorescein model with sensitivity of 100 ugml of fluorescein. The EMC technology was also able to detect 200 ugml of specific antibody in a whole serum sample matrix. Initial accelerated stability studies showed excellent stability of the EAIC components.

Subject Categories:

  • Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE