A Novel Routine Assay for Aids Virus and Other Pathogenic Viruses

Period of Performance: 01/01/1987 - 12/31/1987

$732K

Phase 2 SBIR

Recipient Firm

Diagnostic Specialties, Inc.
PO Box 4338 - 4 Leonard St
Metuchen, NJ 08840
Principal Investigator

Abstract

PHASE I EFFORTS SHOWED THE FEASIBILITY OF A DUAL PROBE FLUORESCENT ASSAY FOR AIDS DNA FRAGMENTS. REAGENTS, INSTRUMENTS AND PROCEDURES WILL BE DEVELOPED FOR THE ROUTINE SCREENING OF BLOOD SAMPLES FOR HIV, THE CAUSATIVE VIRUS FOR AIDS. THE ASSAY WILL DIRECTLY DETECT THE VIRUS, IN CONTRAST TO THE CURRENTLY UTILIZED ASSAYS IN WHICH THE INDIVIDUAL'S ANTIBODY RESPONSE TO THE VIRUS IS MEASURED. THE NEW APPROACH IS DESIGNATED A "DUAL PROBE CONTACT ASSAY." IN THIS ASSAY, A POSITIVE RESPONSE WILL BE ELICITED ONLY WHEN A PAIR OF DIFFERENT DNA PROBES COME IN CONTACT. THIS CONTACT WILL OCCUR ONLY ON THE DESIGNATED TARGET (HIV) DNA. THE RESPONSE ELICITED ON CONTACT WILL BE A FLUORESCENT SIGNAL. TWO CONVENIENT METHODS OF DETECTING THIS FLUORESCENCE WILL BE EXPLORED - AN IMMUNOASSAY TIME DECAY FLUOROMETER (AVAILABLE COMMERCIALLY) AND A POLAROID CAMERA WITH APPROPRIATE LIGHT SOURCE. A 3-DIMENSIONAL MOLECULAR DESIGN STUDY WILL BE UNDERTAKEN IN ORDER TO FACILITATE THE CHOICE OF CHEMICALLY SYNTHESIZED PROBES TO BE PREPARED. THE RESULTING PROBES WILL BE TESTED WITH THE TARGET DNA FOR EFFICACY. THE PROBES WILL BE ALTERED AS NEEDED TO PRODUCE A RESPONSE ONLY WITH THE DESIRED TARGET. IN THE SECOND YEAR OF THE PROJECT IMPLEMENTATION INTO A PRACTICAL ASSAY WILL BE ACCOMPLISHED. THE ASSAY WILL BE OPTIMIZED USING TARGET, SYNTHETIC NUCLEIC ACID ADDED TO NORMAL BLOOD. ONE OR BOTH OF THE ABOVE MENTIONED DETECTION SYSTEMS WILL BE USED ALONG WITH REAGENT AND PROTOCOLS IN A CLINICAL LABORATORY FOR EVALUATION OF BLOOD SAMPLES FOR HIV. COMMERCIALIZATION WILL BE UNDERTAKEN IN PHASE III.