台湾地区人类免疫缺陷病毒抗原/抗体联合检测试剂性能评估。

Evaluation of performance of human immunodeficiency virus antigen/antibody combination assays in Taiwan.

作者信息

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

机构信息

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.

出版信息

J Microbiol Immunol Infect. 2017 Aug;50(4):440-447. doi: 10.1016/j.jmii.2015.07.009. Epub 2015 Aug 29.

DOI:10.1016/j.jmii.2015.07.009

PMID:26433754

Abstract

BACKGROUND

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.

摘要

背景

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。

方法

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。

结果

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。