TY - JOUR
T1 - Performance evaluation of three automated human immunodeficiency virus antigen-antibody combination immunoassays
AU - Kwon, Jung Ah
AU - Yoon, Soo Young
AU - Lee, Chang Kyu
AU - Lim, Chae Seung
AU - Lee, Kap No
AU - Sung, Hyun Ju
AU - Brennan, Catherine A.
AU - Devare, Sushil G.
PY - 2006/3
Y1 - 2006/3
N2 - 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.
AB - 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.
KW - Fourth generation immunoassay
KW - Human immunodeficiency virus (HIV)
KW - Seroconversion
KW - p24 antigen
UR - http://www.scopus.com/inward/record.url?scp=33644922654&partnerID=8YFLogxK
U2 - 10.1016/j.jviromet.2005.10.013
DO - 10.1016/j.jviromet.2005.10.013
M3 - Article
C2 - 16313975
AN - SCOPUS:33644922654
SN - 0166-0934
VL - 133
SP - 20
EP - 26
JO - Journal of Virological Methods
JF - Journal of Virological Methods
IS - 1
ER -
