Performances of four fourth-generation human immunodeficiency virus-1 screening assays.
Fourth-generation human immunodeficiency virus-1 (HIV-1) screening assays have improved sensitivity, but vary in performance characteristics. The purpose of this study was to evaluate four different fourth-generation HIV-1 assays. These assays included the AxSYM HIV Ag/Ab Combo (Abbott diagnostics, Delkenheim, Germany), ARCHITECT HIV Ag/Ab Combo (Abbott), Elecsys 2010 HIV Combi (Roche Diagnostics GmbH, Mannheim, Germany), and Elecsys HIV Combi PT (Roche). A total of 1,306 samples that included 1,225 clinical samples and 81 samples consisting of seroconversion panels, an HIV-1 p24 antigen sensitivity panel, and dilution series of HIV-1 lysates and HIV-1 antibodies were tested. All of the assays had sensitivities of 100% on clinical samples. The specificities of the AxSYM, ARCHITECT, Elecsys 2010 HIV Combi, and Elecsys HIV Combi PT were 99.6, 99.6, 99.0, and 99.5%, respectively. Of the 81 samples with different levels of HIV antigen or antibody and/or subtypes, Elecsys HIV Combi PT and ARCHITECT HIV Ag/Ab Combo showed better analytical sensitivities than the other two assays. In summary, the performance characteristics of AxSYM, ARCHITECT, and Elecsys HIV Combi PT were comparable and satisfactory for clinical samples. ARCHITECT HIV Ag/Ab Combo and Elecsys HIV Combi PT have the higher analytical sensitivities, and would be preferable for reducing the window period.
Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea.
Eun Young
EY
Song
Mina
M
Hur
Eun Youn
EY
Roh
Myoung Hee
MH
Park
Hee-Won
HW
Moon
Yeo Min
YM
Yun
D015153:Blotting, Western; D016001:Confidence Intervals; D015483:HIV Antibodies / Q000097:blood; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007118:Immunoassay / Q000379:methods* / Q000592:standards; D012367:RNA, Viral / Q000097:blood; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D015483:HIV Antibodies; D016655:HIV Core Protein p24; D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic