Simple Semi-Quantitative Device for Hormones in Body Fluids. Phase 1
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 ug/ml and a clinically useful dynamic range of 1 - 20 ug/ml. Feasibility was also demonstrated for a biotin/streptavidin model with sensitivity of 20 ug/ml of biotin and a fluorescein/anti-fluorescein model with sensitivity of 100 ug/ml of fluorescein. The EMC technology was also able to detect 200 ug/ml of specific antibody in a whole serum sample matrix. Initial accelerated stability studies showed excellent stability of the EAIC components.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1996
- Accession Number
- ADB215485
Entities
People
- Gail Shannon
- J. M. Brinkley
- Mark Jackson