ANALYSIS OF DIGOXIN IN SERUM USING A SIMPLE IMMUNOASSAY

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 3239
Amount: $445,000.00
Phase: Phase II
Program: SBIR
Awards Year: 1986
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
5245 Edina Industrial Blvd., Edina, MN, 55435
DUNS: N/A
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 Alan R. Day
 Principal Investigator
 (612) 835-3446
Business Contact
Phone: () -
Research Institution
N/A
Abstract
THE LONG-TERM OBJECTIVE OF THIS WORK IS TO DEVELOP A RAPID, COLORIMETRIC, INSTRUMENT-DEPENDENT ASSAY FOR CARDIO-DIGITALIS CONSTITUENTS, NOTABLY DIGOXIN AND DIGITOXIN. GENESIS LABS' ""IMMUNOSTRIP'' ASSAY (PROTECTED BY PATENT) IS CONSTRUCTED IN A CONFIGURATION THAT IS APPLICABLE FOR THE RAPID DETECTION OF DRUGS AND METABOLITES IN BIOLOGICAL FLUIDS, E.G., URINE, BLOOD, OR SALIVA. THE RELATIVE SIMPLICITY OF THE METHOD SUGGESTS ITS EASY USE BY MEDICALLY UNSOPHISTICATED INDIVIDUALS. WE WILL ATTEMPT INITIALLY TO DETERMINE DIGOXIN IN SERUM AT A LEVEL OF 5 NG/ML. ULTIMATELY, OUR AIM IS TO INCREASE THE SENSITIVITY OF THE ASSAY SYSTEM INTO THE 15 NG/ML RANGE. THIS WILL REQUIRE THE USE OF A HAND-HELD REFLECTOMETER ($1000 PER UNIT CURRENTLY) FOR READING THE STRIPS. HOWEVER, IT IS FEASIBLE BY VARYING THE AMOUNT OF ANTIGEN AND ENZYME MODIFIED ANTIDIGOXIN ANTIBODY WITHIN THE IMMUNOSTRIP THAT WE CAN PRODUCE A VISUAL ASSAY WITHIN THIS LOWER RANGE. THE ASSAY HAS MANY APPLICATIONS FOR MONITORING THERAPEUTIC DRUGS, INCLUDING DIGOXIN, AND THEREFORE WILL HAVE A MAJOR IMPACT ON OUR KNOWLEDGE OF THE HEALTH BENEFIT/RISK RATIO WITHIN POPULATIONS OF OUR SOCIETY WHO REQUIRE DRUGS. BASED ON OUR ABILITY TO MONITOR OTHER HORMONES, DRUGS, AND SMALL HAPTENS USING THIS ASSAY, WE FEEL CONFIDENT THAT IN THE FUTURE, BY USING HIGHLY SPECIFIC POLYCLONAL ANTISERA OR MORE LIKELY MONOCLONAL ANTIBODIES, IT MAY BE POSSIBLE TO MONITOR ACTIVE DIGOXIN AND THEREBY PREDICT THERAPEUTIC VERSUS TOXIC LEVELS OF DIGOXIN IN A PHYSICIAN'S OFFICE WITH A ONE-MINUTE TEST.

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

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