Simple Semi-Quantitative Device for Hormones in Body Fluids

Period of Performance: 03/31/1997 - 03/30/1999

$743K

Phase 2 SBIR

Recipient Firm

Emerald Diagnostics, Inc.
1720 Willow Creek Circle Suite B
Eugene, OR 97402
Principal Investigator

Research Topics

Abstract

Pinpointing hormonal cycle phases through daily blood analyses is expensive and impractical by routine laboratory methods. Immunochemical test strips are, in principle, an attractive alternative since critical concentration ranges of key hormones or metabolites in body fluids, such as saliva, urine or blood can be rapidly quantitated with minimal sample treatment at modest cost. In Phase I studies Emerald Diagnostics demonstrated feasibility and sensitivity of a semi-quantitative immunochromatographic test strip platform in the form of a single analyte device for measuring metabolized progesterone as pregnanediol-3-glucuronide (PDG) in urine. Critical determinants of sensitivity were identified and proprietary enzyme amplification techniques to increase test sensitivity by 10-100 fold over currently available methods were demonstrated, with potential for adaptation to measurement of multiple analytes. The Phase II work plan comprises the transfer of the Phase I demonstrations of feasibility to pilot production of a simple semi-quantitative device for PDG in urine with extensive evaluation of product performance, including preclinical trials, production design, process optimization, and a product design review to make appropriate adjustments to the technical specifications of the product. Most of the Phase II work plan will be carried out at EDI facilities by EDI personnel. Development of the technology provides critical design elements of a broadly applicable immunodiagnostic platform for various medical, veterinary and environmental test issues, including hormone tests for pregnancy (human urine or bovine milk), fertility, and for low molecular weight compounds of clinical or environmental concern.