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

AIDS Res Hum Retroviruses. 2003 Jun;19(6):481-6. doi: 10.1089/088922203766774522.

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.

Publication types

  • Evaluation Study

MeSH terms

  • AIDS Serodiagnosis*
  • Adult
  • Algorithms*
  • Female
  • HIV Antibodies / blood
  • HIV Infections / diagnosis
  • HIV Infections / epidemiology*
  • HIV Infections / virology
  • HIV-1 / classification*
  • HIV-1 / immunology
  • Humans
  • Immunoenzyme Techniques
  • Incidence
  • Male
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • Substance Abuse, Intravenous / complications*
  • Thailand / epidemiology

Substances

  • HIV Antibodies
  • Reagent Kits, Diagnostic