title: Evaluation of a sensitive/less sensitive testing algorithm using the bioMérieux Vironostika-LS assay for detecting recent HIV-1 subtype B' or E infection in Thailand.
abstract: The performance of the bioMérieux Vironostika-LS EIA (less sensitive enzyme immunoassay) was assessed to detect recent seroconversion among injecting drug users (IDUs) in Bangkok, Thailand who were infected with either HIV-1 subtypes B' or E (also known as circulating recombinant form CRF01_AE). To evaluate the Vironostika-LS EIA in non-B subtypes, we collected longitudinal specimens (n = 796) from 115 IDUs (subtype B' infection, n = 24; subtype E infection, n = 91). After testing HIV-positive specimens with the Vironostika-LS EIA, standardized optical densities (SODs) were calculated using median values to determine the window period, which is the time from seroconversion on a standard EIA to seroconversion on the Vironostika-LS EIA for a given SOD, for either subtype. For an SOD cutoff of 1.0, Vironostika-LS EIA results showed a mean window period of 239 days (95% confidence interval [95% CI], 208-287 days) for subtype B' and 356 days (95% CI, 318-402 days) for subtype E in Thailand. This outcome demonstrates that the Vironostika-LS EIA has significantly different performance characteristics in detecting recent seroconversion between different HIV-1 subtypes. Accurate identification of recent infection and estimation of incidence for HIV-1 strains other than North American subtype B, using the Vironostika-LS EIA, requires knowledge of specimen subtype and use of appropriate cutoffs and mean window periods.
authors.affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia 30333, USA. cyoung@cdc.gov
authors.forename: Carrie L
authors.initials: CL
authors.lastname: Young
authors.forename: Dale J
authors.initials: DJ
authors.lastname: Hu
authors.forename: Robert
authors.initials: R
authors.lastname: Byers
authors.forename: Suphak
authors.initials: S
authors.lastname: Vanichseni
authors.forename: Nancy L
authors.initials: NL
authors.lastname: Young
authors.forename: Robert
authors.initials: R
authors.lastname: Nelson
authors.forename: Philip A
authors.initials: PA
authors.lastname: Mock
authors.forename: Kachit
authors.initials: K
authors.lastname: Choopanya
authors.forename: Robert
authors.initials: R
authors.lastname: Janssen
authors.forename: Timothy D
authors.initials: TD
authors.lastname: Mastro
authors.forename: Joanne V
authors.initials: JV
authors.lastname: Mei
mesh_terms: D015492:AIDS Serodiagnosis; D000328:Adult; D000465:Algorithms; D005260:Female; D015483:HIV Antibodies / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis / Q000453:epidemiology* / Q000821:virology; D015497:HIV-1 / Q000145:classification* / Q000276:immunology; D006801:Humans; D007124:Immunoenzyme Techniques; D015994:Incidence; D008297:Male; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D015819:Substance Abuse, Intravenous / Q000150:complications*; D013785:Thailand / Q000453:epidemiology
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic