Evaluation of a new fourth generation enzyme-linked immunosorbent assay, the LG HIV Ag-Ab Plus, with a combined HIV p24 antigen and anti-HIV-1/2/O screening test

J Virol Methods. 2006 Nov;137(2):292-7. doi: 10.1016/j.jviromet.2006.07.002. Epub 2006 Aug 14.

Abstract

The LG HIV Ag-Ab Plus, a new fourth generation diagnostic assay for HIV infection, was evaluated in comparison to the Enzygnost HIV Integral, an established fourth generation HIV assay. The LG assay showed 100% sensitivity with 109 samples with anti-HIV-1, anti-HIV-2 or anti-HIV-1 group O reactivity. It also detected correctly all 51 positives on three BBI performance panels, slightly outperforming the Enzygnost HIV Integral, which detected 50. The specificity of the LG HIV Ag-Ab Plus was 99.9% with 999 sera from healthy blood donors, which was slightly inferior to the performance of the Enzygnost HIV Integral, which had 100% specificity. The LG assay showed 100% specificity with 81 specimens with underlying diseases including hepatitis B, demonstrating a low risk of cross-reactivity with other infections. The reduction of the diagnostic window by the LG HIV Ag-Ab Plus, compared to a third generation HIV assay, was 6.3 days. The LG assay also showed sufficiently high intra-person and inter-person reproducibility. The overall performance of this new fourth generation HIV assay was adequate for screening and diagnosis of HIV infection.

Publication types

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

MeSH terms

  • AIDS Serodiagnosis / methods*
  • Enzyme-Linked Immunosorbent Assay / methods*
  • HIV / immunology*
  • HIV Antibodies / blood*
  • HIV Core Protein p24 / blood*
  • HIV Infections / diagnosis*
  • Humans
  • Reagent Kits, Diagnostic
  • Reproducibility of Results
  • Sensitivity and Specificity

Substances

  • HIV Antibodies
  • HIV Core Protein p24
  • Reagent Kits, Diagnostic