title: Synthetic-peptide-based enzyme-linked immunosorbent assay for screening human serum or plasma for antibodies to human immunodeficiency virus type 1 and type 2.
abstract: A synthetic-peptide-based enzyme-linked immunosorbent assay (EIA) capable of screening for antibodies to both human immunodeficiency virus type 1 (HIV-1) and HIV-2 has been developed for use in blood banks and diagnostic laboratories. Microtiter wells are coated with two synthetic peptides, one corresponding to the highly conserved envelope region of 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 reactive (RR)-HIV-1 Western blot (WB)-positive repository specimens, and 100% for 222 geographically diverse HIV-1 specimens and 216 confirmed HIV-2-positive specimens evaluated. The specificity was determined to be 99.72% for a total of 13,004 serum and plasma samples from random volunteer donors evaluated across five blood banks. Forty donors who were found to be EIA 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 and Drug Administration-licensed HIV-1 and HIV-1-HIV-2 assays that are currently available in the United States. The UBI HIV 1/2 EIA affords laboratories another choice in the detection of antibodies for HIV-1 and HIV-2 with a test based on an alternative antigen format.
authors.affiliation: United Biomedical, Inc., Hauppauge, New York 11788, USA.
authors.forename: L
authors.initials: L
authors.lastname: Gonzalez
authors.forename: R W
authors.initials: RW
authors.lastname: Boyle
authors.forename: M
authors.initials: M
authors.lastname: Zhang
authors.forename: J
authors.initials: J
authors.lastname: Castillo
authors.forename: S
authors.initials: S
authors.lastname: Whittier
authors.forename: P
authors.initials: P
authors.lastname: Della-Latta
authors.forename: L M
authors.initials: LM
authors.lastname: Clarke
authors.forename: J R
authors.initials: JR
authors.lastname: George
authors.forename: X
authors.initials: X
authors.lastname: Fang
authors.forename: J G
authors.initials: JG
authors.lastname: Wang
authors.forename: B
authors.initials: B
authors.lastname: Hosein
authors.forename: C Y
authors.initials: CY
authors.lastname: Wang
mesh_terms: D015492:AIDS Serodiagnosis; D015153:Blotting, Western; D004797:Enzyme-Linked Immunosorbent Assay; D005069:Evaluation Studies as Topic; D015483:HIV Antibodies / Q000097:blood*; D015497:HIV-1 / Q000276:immunology*; D015498:HIV-2 / Q000276:immunology*; D006801:Humans; D012680:Sensitivity and Specificity; D014614:Vaccines, Synthetic
chemical_list: D015483:HIV Antibodies; D014614:Vaccines, Synthetic