Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays

Jung Ah Kwon, Soo Young Yoon, Chang Kyu Lee, Chae Seung Lim, Kap No Lee, Hyun Ju Sung, Catherine A. Brennan, Sushil G. Devare

Research output: Contribution to journalArticle

55 Citations (Scopus)

Abstract

Three fourth-generation antigen/antibody combination assays (Elecsys, AxSYM, Architect HIV) and two third-generation (AxSYM, Centaur) HIV antibody immunoassays were evaluated. The evaluation panel of 479 samples included: nine tissue culture derived HIV-1 strains at four different p24 antigen concentrations (n = 36), a p24 antigen sensitivity panel (n = 10), 149 HIV-1 or HIV-2 confirmed antibody positive samples, ten anti-HIV-1 positive low titer samples, three seroconversion panels (n = 21), and 253 HIV negative samples. The Architect had the best sensitivity for detection of HIV-1 antigen across eight HIV-1 subtypes, followed by the AxSYM while the Elecsys could not detect the highest antigen concentration evaluated (25 pg/mL) for eight of nine virus isolates. All assays showed 100% sensitivity for detection of HIV-1, group M, group O, and HIV-2 antibody positive samples. The Architect Ag/Ab Combo assay detected the first positive bleed of the three seroconversion panels and detected infection 4-26 days earlier than the third generation assays. Based on evaluation of 253 negative samples, assay specificity varied from 98.0% to 99.6%. The Architect HIV Ag/Ab Combo exhibited the best performance for specificity and detection of p24 antigen leading to closure of seroconversion window and demonstrating its utility for early diagnosis of HIV infection.

Original languageEnglish
Pages (from-to)20-26
Number of pages7
JournalJournal of Virological Methods
Volume133
Issue number1
DOIs
Publication statusPublished - 2006 Mar

Keywords

  • Fourth generation immunoassay
  • Human immunodeficiency virus (HIV)
  • Seroconversion
  • p24 antigen

ASJC Scopus subject areas

  • Virology

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