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

54 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 1

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Immunoassay
HIV-1
HIV
Antigens
Antibodies
HIV Antibodies
HIV-2
HIV Antigens
HIV Infections
Early Diagnosis
Viruses
Infection
Seroconversion

Keywords

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

ASJC Scopus subject areas

  • Virology

Cite this

Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays. / Kwon, Jung Ah; Yoon, Soo-Young; Lee, Chang Kyu; Lim, Chae Seung; Lee, Kap No; Sung, Hyun Ju; Brennan, Catherine A.; Devare, Sushil G.

In: Journal of Virological Methods, Vol. 133, No. 1, 01.03.2006, p. 20-26.

Research output: Contribution to journalArticle

Kwon, Jung Ah ; Yoon, Soo-Young ; Lee, Chang Kyu ; Lim, Chae Seung ; Lee, Kap No ; Sung, Hyun Ju ; Brennan, Catherine A. ; Devare, Sushil G. / Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays. In: Journal of Virological Methods. 2006 ; Vol. 133, No. 1. pp. 20-26.
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