Chang Chun-Kai, Kao Cheng-Feng, Lin Pi-Han, Huang Hui-Lin, Ho Shu-Yuan, Wong Kuo-Chen, Lin Bo-Chang, Yeh Chang-Ching, Lee Chia-Yeh, Kao Chuan-Liang, Lee Chun-Nan, Chang Sui-Yuan, Yang Jyh-Yuan
Department of Clinical Laboratory Sciences and Medical Biotechnology, National Taiwan University College of Medicine, Taipei, Taiwan.
Center for Research, Diagnostics and Vaccine Development, Centers for Disease Control, Taipei, Taiwan.
J Microbiol Immunol Infect. 2017 Aug;50(4):440-447. doi: 10.1016/j.jmii.2015.07.009. Epub 2015 Aug 29.
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.
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.
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.
The three fourth-generation HIV Ag/Ab combination assays exhibited better sensitivity, specificity, and negative prediction than the third-generation HIV Ab immunoassay.
第四代人类免疫缺陷病毒（HIV）联合检测法可同时检测抗HIV抗体和HIV抗原的存在，与第三代HIV抗体免疫测定法相比，已被证明可缩短HIV诊断的窗口期。本研究旨在确定在台湾地区HIV联合检测法的性能，台湾地区的HIV-1血清流行率为0.007%，且从未报告过HIV-2感染病例。
评估了三种第四代HIV抗原/抗体联合检测法（Dia.Pro、万泰、伯乐）和一种第三代HIV抗体免疫测定法（AxSYM HIV 1/2 gO）的性能。
本研究共使用了152份标本，其中包括86份确诊的HIV血清阳性样本和66份HIV血清阴性样本。四种检测方法的灵敏度在98.8%至100%之间，特异性在98.5%至100%之间。75份结果不明确样本（其HIV状态随后得到确认）的阴性预测性能在81.8%至87.5%之间。在三种第四代HIV联合检测法中，伯乐和Dia.Pro检测法对p24抗原的检测灵敏度更高。
三种第四代HIV抗原/抗体联合检测法在灵敏度、特异性和阴性预测方面均优于第三代HIV抗体免疫测定法。
