DETECTION OF THEOPHYLLINE USING A SIMPLE IMMUNOASSAY

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$296,000.00
Award Year:
1987
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
3240
Agency Tracking Number:
3240
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
5245 Edina Industrial Blvd., Edina, MN, 55435
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Alan R. Day
Principal Investigator
(612) 835-3446
Business Contact:
() -
Research Institute:
n/a
Abstract
THE LONG-TERM OBJECTIVE OF THIS WORK IS TO DEVELOP A RAPID, COLORIMETRIC, INSTRUMENT-DEPENDENT ASSAY FOR THEOPHYLLINE CONSTITUENTS. 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 THEOPHYLLINE IN SERUM AT A LEVEL OF 5 G/ML. ULTIMATELY, OUR AIM IS TO INCREASE THE SENSITIVITY OF THE ASSAY SYSTEM INTO THE 1-50 G/ML RANGE. THIS WILL REQUIRE THE USE OF A HAND-HELD REFLECTOMETER ($1,000 PER UNIT CURRENTLY) FOR READING THE STRIPS. HOWEVER, IT IS FEASIBLE BY VARYING THE AMOUNT OF ANTIGEN AND ENZYME MODIFIED ANTITHEOPHYLLINE WITHIN THE IMMUNOSTRIP THAT WE CAN PRODUCE A VISUAL ASSAY WITHIN THIS LOWER RANGE. THE ASSAY HAS MANY APPLICATIONS FOR MONITORING THERAPEUTIC DRUGS, INCLUDING THEOPHYLLINE, 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 THEOPHYLLINE AND INACTIVE METABOLITES IN BLOOD AND THEREBY PREDICT THERAPEUTIC VERSUS TOXIC LEVELS OF THEOPHYLLINE IN A PHYSICIAN'S OFFICE WITH A ONE-MINUTE TEST.

* information listed above is at the time of submission.

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