IN SITU HYBRIDIZATION FOR HUMAN IMMUNODEFICIENCY VIRUS

MOLECULAR ANALYSIS, INC. (MAI) HAS DEVELOPED AN IN SITU HYBRIDIZATION PROCEDURE THAT IS RAPID (LESS THAN 2 HOURS), SENSITIVE (CAN DETECT ONE MOLECULE), INEXPENSIVE (REAGENTS COST LESS THAN $1.00), AND NONISOTOPIC. THIS PROCEDURE IS READY FOR TESTING THE FEASIBILITY OF USING IT TO DETECT THE HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) IN THE PERIPHERAL BLOOD OF INDIVIDUALS WITH EVIDENCE OF INFECTION BY HIV-1 OR WITH NO EVIDENCE OF INFECTION BUT AT HIGH RISK FOR INFECTION BY HIV-1. MAI WILL OBTAIN PERIPHERAL BLOOD FROM 25 INDIVIDUALS IN EACHOF THE FOUR FOLLOWING CATEGORIES: (1) WITH DISEASE: ACQUIREDIMMUNODEFICIENCY SYNDROME (AIDS), AIDS-RELATED COMPLEX, OR KAPOSI'S SARCOMA; (2) WITH NO EVIDENCE OF DISEASE BUT SEROPOSITIVE FOR HIV-1; (3) WITH NO EVIDENCE OF DISEASE BUT AT HIGH RISK FOR HIV-1 INFECTION AND SERONEGATIVE; (4) WITH NO EVIDENCE OF DISEASE, AT NO RISK FOR HIV-1 INFECTION, AND SERONEGATIVE. ON THESE 100 BLOOD SAMPLES, MAI WILL ANALYZE ALL SERA BY ELISA AND WESTERN BLOT FOR HIV-1 ANTIBODIES, ALL DNA BY POLYMERASE CHAIN REACTION, AND ALL PERIPHERAL BLOOD CELLS BYAN IN SITU HYBRIDIZATION PROCEDURE. THESE DATA WILL ALLOW MAI TO COMPARE IN SITU RESULTS WITH BOTH SEROLOGICAL TESTINGAND WITH A SECOND DNA PROBE-BASED TEST. IF THE RAPID, INEXPENSIVE, NONISOTOPIC DETECTION OF EXTREMELY SMALL QUANTITIES OF HIV-1 NUCLEIC ACID IN PERIPHERAL BLOOD IS FEASIBLE, THEN MAI MAY HAVE DEVELOPED AN EXTREMELY USEFUL METHOD TO SCREEN FOR OR CONFIRM THE PRESENCE OF ACTIVE OR LATENT AIDS VIRUS IN BLOOD CELLS.