SYNTHETIC-PEPTIDE-BASED ENZYME-LINKED-IMMUNOSORBENT-ASSAY FOR SCREENING HUMAN SERUM OR PLASMA FOR ANTIBODIES TO HUMAN-IMMUNODEFICIENCY-VIRUS TYPE-1 AND TYPE-2

A synthetic-peptide-based enzyme-linked immunosorbent assay (EIA) capa ble of screening for antibodies to both human immunodeficiency virus t ype 1 (HN-I) and HIV-2 has been developed for use in blood banks and d iagnostic laboratories. Microtiter wells are coated with two synthetic peptides, one corresponding to the highly conserved envelope region o f HIV-1 and another corresponding to the conserved envelope region of HIV-2, Overall, sensitivity was 100% in 303 individuals diagnosed with AIDS and 96 individuals diagnosed with AIDS-related complex, 14.8% in a study of 500 high-risk group members, 99.9% in 600 EIA repeatedly r eactive (RR)-HIV-1 Western blot (WB)-positive repository specimens, an d 100% for 222 geographically diverse HIV-1 specimens and 216 confirme d HIV-2-positive specimens evaluated, The specificity was determined t o be 99.72% for a total of 13,004 serum and plasma samples from random volunteer donors evaluated across five blood banks. Forty donors mho were found to be ELA RR-WB indeterminate but nonreactive on the United Biomedical, Inc., test (UBI HIV 1/2 EIA) were prospectively followed as an additional measure of specificity, None of the 40 low-risk cases evolved into a positive WB pattern at follow-up. The sensitivity and specificity of this new assay are comparable to those of other Food an d Drug Administration-licensed HIV-1 and HIV-1-HIV-2 assays that are c urrently available in the United States. The UBI HIV lit EPA affords l aboratories another choice in the detection of antibodies for HIV-I an d HIV-2 with a test based on an alternative antigen format.