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Cited 54 time in webofscience Cited 56 time in scopus
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Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays

Authors
Kwon, Jung-AhYoon, Soo-YoungLee, Chang-KyuLim, Chae SeungLee, Kap NoSung, Hyun JuBrennan, Catherine A.Devare, Sushil G.
Issue Date
Apr-2006
Publisher
ELSEVIER SCIENCE BV
Keywords
fourth generation immunoassay; human immunodeficiency virus (HIV); p24 antigen; seroconversion
Citation
JOURNAL OF VIROLOGICAL METHODS, v.133, no.1, pp 20 - 26
Pages
7
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF VIROLOGICAL METHODS
Volume
133
Number
1
Start Page
20
End Page
26
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/18915
DOI
10.1016/j.jviromet.2005.10.013
ISSN
0166-0934
1879-0984
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 = 2 1), 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 0, 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. (c) 2005 Elsevier B.V. All rights reserved.
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