title: Performance characteristics of a new less sensitive HIV-1 enzyme immunoassay for use in estimating HIV seroincidence.
abstract: Less sensitive (LS) HIV-1 enzyme immunoassays (EIAs) have significantly improved the quantity and quality of HIV surveillance data. The first LS-HIV-1 EIA, the Abbott 3A11-LS, provided reliable incidence data, but the assay required specialized equipment, and the lack of available reagents made testing difficult. This study evaluated the use of an alternate assay, a modified version of the Vironostika HIV-1 EIA (Vironostika-LS), to be used for LS testing. The Vironostika-LS has similar performance characteristics to the Abbott 3A11-LS with additional advantages. This 96-well formatted assay is commonly found in public health laboratories for routine HIV-1 testing and can be used with both serum and dried blood spot specimens. The estimated mean time from seroconversion (defined using a standardized optical density cutoff of 1.0) with the Vironostika-LS was 170 days (95% CI, 145-200 days). When the Vironostika-LS was applied to a matched serum set previously tested with the Abbott 3A11-LS, the Vironostika-LS accurately identified 97% of specimens with recent or long-standing HIV infection. The paper also reports Vironostika-LS quality control guidelines and the results from 3 rounds of proficiency testing.
authors.affiliation: Division of Laboratory Sciences, National Center for Environmental Health, Atlanta, Georgia 30341, USA.
authors.forename: Denise
authors.initials: D
authors.lastname: Kothe
authors.forename: Robert H
authors.initials: RH
authors.lastname: Byers
authors.forename: Samuel P
authors.initials: SP
authors.lastname: Caudill
authors.forename: Glen A
authors.initials: GA
authors.lastname: Satten
authors.forename: Robert S
authors.initials: RS
authors.lastname: Janssen
authors.forename: W Harry
authors.initials: WH
authors.lastname: Hannon
authors.forename: Joanne V
authors.initials: JV
authors.lastname: Mei
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D005260:Female; D017408:Guidelines as Topic; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000453:epidemiology; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D008297:Male; D011237:Predictive Value of Tests; D011786:Quality Control; D012044:Regression Analysis; D015203:Reproducibility of Results; D013048:Specimen Handling
chemical_list: D015483:HIV Antibodies