Chang C.-K.Kao C.-F.Lin P.-H.Huang H.-L.Ho S.-Y.Wong K.-C.Lin B.-C.Yeh C.-C.Lee C.-Y.CHUAN-LIANG KAOLee C.-N.SUI-YUAN CHANGYang J.-Y.2020-07-032020-07-0320171684-1182https://scholars.lib.ntu.edu.tw/handle/123456789/507992Background The fourth-generation human immunodeficiency virus (HIV) combination assay, which can simultaneously detect the presence of anti-HIV antibody and HIV antigen, has been shown to shorten the window period in HIV diagnosis compared with the third-generation HIV antibody immunoassay. This study was aimed to determine the performance of HIV combination assays in Taiwan, where the HIV-1 seroprevalence is 0.007% and HIV-2 infection has never been reported. Methods Performance of three fourth-generation HIV Ag/Ab combination assays (Dia.Pro, Wantai, and Bio-Rad) and one third-generation HIV Ab immunoassay (AxSYM HIV 1/2 gO) was assessed. Results A total of 152 specimens, including 86 confirmed HIV-seropositive and 66 HIV-seronegative samples, were used in the study. The sensitivity of four assays varied from 98.8% to 100%, and specificity varied from 98.5% to 100%. Performance of the 75 equivocal samples, the HIV status of which was confirmed later, in terms of negative prediction varied from 81.8% to 87.5%. The Bio-Rad and Dia.Pro assays exhibited higher sensitivity for the detection of p24 antigen among the three fourth-generation HIV combination assays. Conclusion The three fourth-generation HIV Ag/Ab combination assays exhibited better sensitivity, specificity, and negative prediction than the third-generation HIV Ab immunoassay. ? 2015[SDGs]SDG3antigen p24; Human immunodeficiency virus antibody; Human immunodeficiency virus antigen; Human immunodeficiency virus antibody; Human immunodeficiency virus antigen; antibody detection; antigen detection; Article; controlled study; follow up; HIV test; human; Human immunodeficiency virus 1 group M; Human immunodeficiency virus 1 group O; Human immunodeficiency virus 1 infection; Human immunodeficiency virus 2; Human immunodeficiency virus 2 infection; human immunodeficiency virus antigen antibody combination assay; Human immunodeficiency virus infection; immunoassay; immunoassay analyzer; nonhuman; predictive value; sensitivity and specificity; Taiwan; virus load; Western blotting; blood; comparative study; diagnostic test; evaluation study; Human immunodeficiency virus; Human immunodeficiency virus infection; immunoassay; immunology; isolation and purification; procedures; Diagnostic Tests, Routine; HIV; HIV Antibodies; HIV Antigens; HIV Infections; Humans; Immunoassay; Sensitivity and Specificity; Taiwanjournal article10.1016/j.jmii.2015.07.009264337542-s2.0-84945566563