CONTROL CELL LINES FOR USE IN MOLECULAR DIAGNOSTIC TESTS

THE SPECIFIC AIM IS TO DEVELOP HUMAN CELL LINES CONTAINING SPECIFIC, CLONED GENES OF THE PATHOGENIC VIRUS, HIV, THE CAUSATIVE AGENT OF AIDS. EACH CELL LINE WILL CONTAIN ONLY ONE INDIVIDUAL GENE OF HIV, EXPRESSED BY A EUKARYOTIC GENE PROMOTER. THESE CELL LINES WILL PROVIDE A NONINFECTIOUS, POSITIVE CONTROL STANDARD FOR SUCH DIAGNOSTIC MOLECULAR TESTS AS SOUTHERN ANALYSIS, NORTHERN ANALYSIS, IN SITU HYBRIDIZATION, AND THE POLYMERASE CHAIN REACTION. THE USE OF MOLECULAR BIOLOGY AS A DIAGNOSTIC TOOL IS GROWINGWORLDWIDE. AS THE INCLUSION OF A KNOWN POSITIVE CONTROL IS NECESSARY IN EVERY TEST, THESE NONINFECTIOUS CELL LINES WOULD ACT AS A STANDARD CONTROL. CURRENTLY, INFECTED MATERIALS FROM PATIENTS WITH AIDS ACT AS THESE CONTROLS. THESE MATERIALS ARE INFECTIOUS AND POSE A DIRECT HEALTH HAZARD TO THE LABORATORY WORKER. BY EMPLOYING THESE CONTROLCELL LINES, THAT RISK WOULD BE ELIMINATED. AIDS IS ONLY ONE OF MANY BLOOD-BORNE INFECTIOUS AGENTS. OTHER CONTROL CELL LINES, CONTAINING THE INDIVIDUAL GENES OFHTLV-I, HEPATITIS B, AND HUMAN PAPILLOMA VIRUS COULD ALSO BEDEVELOPED.