Performance characteristics of a new less sensitive HIV-1 enzyme immunoassay for use in estimating HIV seroincidence

J Acquir Immune Defic Syndr. 2003 Aug 15;33(5):625-34. doi: 10.1097/00126334-200308150-00012.

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.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS Serodiagnosis / methods*
  • Female
  • Guidelines as Topic
  • HIV Antibodies / blood
  • HIV Infections / blood
  • HIV Infections / diagnosis*
  • HIV Infections / epidemiology
  • HIV-1 / isolation & purification*
  • Humans
  • Male
  • Predictive Value of Tests
  • Quality Control
  • Regression Analysis
  • Reproducibility of Results
  • Specimen Handling

Substances

  • HIV Antibodies