STANDARDIZATION OF ASSAY FOR ANTIBODIES TO ISLET CELLS

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$350,000.00
Award Year:
1988
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Agency Tracking Number:
4882
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Immco Diagnostics
963 Kenmore Avenue, Buffalo, NY, 14223
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Jay G Huang
Principal Investigator
(716) 876-5672
Business Contact:
() -
Research Institution:
n/a
Abstract
THE TEST FOR ISLET CELL CYTOPLASMIC ANTIBODIES (ICA) IS A GOOD PREDICTOR OF INDIVIDUALS AT RISK TO DEVELOP TYPE I DIABETES AND THUS HAS POTENTIAL VALUE IN IDENTIFYING CANDI- DATES FOR FUTURE MEASURES AIMED AT PREVENTING THE DISEASE. HOWEVER, PROBLEMS WITH STANDARDIZATION LIMIT THE RELIABILITYOF THE ICA ASSAY. THE GOAL OF THIS PROJECT IS TO MAKE AVAILABLE A STANDARDIZED, AND HENCE MORE RELIABLE, SYSTEM FOR DETECTING ICA. SPECIFIC OBJECTIVES ARE TO: (1) ESTABLISH A PROTOCOL FOR PROCURING DONOR PANCREAS THAT RESULTS IN OPTIMAL REACTIVITY AND RETENTION OF TISSUE MORPHOLOGY; (2) ESTABLISH THE MOST SENSITIVE AND REPRODUC- IBLE FLUORESCENT INDICATOR SYSTEM FOR VISUALIZING THE ICA REACTION; (3) MAXIMIZE THE STABILITY OF ISLET CELL ANTIGENS IN TISSUE SECTIONS; AND (4) DEVELOP A SEPARATE PARALLEL SYSTEM THAT ALLOWS THE USER TO ASSESS HIS SKILLS IN PERFORMING, READING, AND INTERPRETING THE ICA TEST. THESE AIMS WILL BE ADDRESSED BY: (1) DOCUMENTING TIME LIMITS FOR TISSUE PROCESSING BEYOND WHICH REACTIVITY AND HISTOLOGY DETERIORATE AND EXAMINING PANCREAS PERFUSION AS A MEANS OF EXTENDING THESE TIME LIMITS; (2) COMPARING FIVE FLOURESCENT INDICATORS FOR SPECIFICITY, SENSITIVITY, AND REPRODUCIBILITYIN THE ICA ASSAY; (3) COMPARING SHELF-LIVES OF PANCREAS SECTIONS AFTER VARIOUS MODES OF FIXATION; AND (4) DEVELOPINGTHE COMPONENTS OF A USER STANDARDIZATION KIT. THIS RESEARCHWILL LAY THE GROUNDWORK FOR PHASE II DEVELOPMENT OF A COMMERCIALLY MARKETABLE ICA ASSAY PACKAGE.

* information listed above is at the time of submission.

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