Comparative evaluation of three FDA-approved HIV Ag/Ab combination tests using a genetically diverse HIV panel and diagnostic specimens

J Clin Virol. 2017 Jul;92:62-68. doi: 10.1016/j.jcv.2017.05.005. Epub 2017 May 13.

Abstract

Background: HIV Ag/Ab combination assays are recommended by CDC for routine screening and several HIV Ag/Ab combination tests are now FDA-approved. Maintaining high specificity and consistent sensitivity across diverse HIV strains is critical for these assays to accurately detect HIV infection and expedite delivery of patient results.

Objectives: To evaluate performance of three FDA-approved HIV tests: ARCHITECT HIV Combo (Abbott), ADVIA Centaur HIV Combo (Siemens) and BioPlex HIV Ag-Ab (Bio-Rad).

Study design: Sensitivity and specificity were evaluated using an extensive panel of 28 HIV infected human specimens and 17 cultured virus isolates representing multiple genotypes, 6 seroconversion panels, 4 human samples with acute infection, WHO p24 standard and 4020 clinical specimens.

Results: The p24 limit of detection (LOD) for the WHO standard was 0.19IU/ml, 0.70IU/ml, and 1.77IU/ml in BioPlex, ARCHITECT, and Centaur respectively. The distribution of LODs across 15 HIV-1 isolates was substantially narrower in ARCHITECT (5-33pg/ml) than in BioPlex (11-198pg/ml) and Centaur (6-384pg/ml). All assays detected antibodies to the majority of HIV-1 and HIV-2 variants. However, reduced sensitivity was observed for Centaur in detection of antibodies to HIV-1 group M (CRF02_AG), O and N variants. BioPlex and ARCHITECT showed better seroconversion sensitivity than Centaur, detecting one bleed (3-7 days) earlier in 4 (BioPlex) and 3 (ARCHITECT) of 6 seroconversion panels. ARCHITECT demonstrated the highest specificity (99.90-100%) compared to BioPlex (99.80%) and Centaur (99.42%).

Conclusions: The overall performance of ARCHITECT and BioPlex was superior to Centaur, especially for detection of acute HIV infection.

Keywords: Acute HIV infection; Clinical specificity; Genetic diversity; HIV antigen and antibody combination test.

Publication types

  • Comparative Study
  • Evaluation Study

MeSH terms

  • AIDS Serodiagnosis*
  • Diagnostic Test Approval
  • Genetic Variation
  • HIV Antibodies / blood*
  • HIV Antigens / blood*
  • HIV Antigens / genetics
  • HIV Antigens / immunology
  • HIV Infections / diagnosis*
  • HIV Infections / immunology
  • HIV Infections / virology
  • HIV-1 / genetics
  • HIV-1 / immunology
  • HIV-1 / isolation & purification
  • HIV-2 / genetics
  • HIV-2 / immunology
  • HIV-2 / isolation & purification
  • Humans
  • Mass Screening
  • Reagent Kits, Diagnostic
  • Sensitivity and Specificity
  • United States
  • United States Food and Drug Administration
  • Viral Load / instrumentation
  • Viral Load / methods

Substances

  • HIV Antibodies
  • HIV Antigens
  • Reagent Kits, Diagnostic