Han Hui, Huang Yanhua, Dong Qian, Huang Yunxiu, Lu Jianqiang, Wang Weijia, Chen Kang
Clin Lab. 2019 Oct 1;65(10). doi: 10.7754/Clin.Lab.2019.190220.
Human immunodeficiency virus infection and acquired immunodeficiency syndrome (HIV/AIDS) are infectious diseases with high mortality. Early diagnosis is crucial. Combining HIV antibody and p24 antigen, the Elecsys HIV combi PT assay is a fourth generation HIV screening assay. The sensitivity and specificity of this assay was examined.
A total of 111,556 samples was conducted from January 1, 2016, to June 30, 2018 in Zhongshan Hospital of Yat-Sen University. We conducted a fourth-generation HIV test of retrospective HIV screening samples and assessed the reliability of using signal-to-cutoff (S/CO) ratios to distinguish false positive HIV antibody reactions and analyzed false positives.
A total of 122 specimens were confirmed as HIV-1 infected by western blot (WB) and HIV nucleic acid assays. The median S/CO ratio for HIV false positive specimens was 3.27, while for the HIV-infected specimen it was 391.7. Receiver operating characteristic (ROC) analysis showed that the best diagnostic point for HIV was 22.85 S/CO. The sensitivity, specificity, and Youden index were 100%, 97.8%, and 0.978, respectively. The highest false positive rate of 26.4% was found in patients with malignant tumors and blood diseases.
The results of this study show that the fourth-generation Elecsys HIV combination PT test can identify early HIV infected and can be a useful adjunct to help clinicians to manage the disease by viral load testing and starting an appropriate therapy. Our research data provides a reference for subsequent research and HIV testing in the region.
人类免疫缺陷病毒感染和获得性免疫缺陷综合征（HIV/AIDS）是死亡率很高的传染病。早期诊断至关重要。Elecsys HIV combi PT检测是一种将HIV抗体和p24抗原相结合的第四代HIV筛查检测方法。本研究对该检测方法的灵敏度和特异性进行了检测。
2016年1月1日至2018年6月30日期间，中山大学附属中山医院共检测了111,556份样本。我们对回顾性HIV筛查样本进行了第四代HIV检测，并评估了使用信号与临界值（S/CO）比值来区分HIV抗体假阳性反应的可靠性，并分析了假阳性情况。
共有122份标本经免疫印迹法（WB）和HIV核酸检测确诊为HIV-1感染。HIV假阳性标本的S/CO比值中位数为3.27，而HIV感染标本的S/CO比值中位数为391.7。受试者工作特征（ROC）分析显示，HIV的最佳诊断点为22.85 S/CO。灵敏度、特异性和尤登指数分别为100%、97.8%和0.978。恶性肿瘤和血液疾病患者的假阳性率最高，为26.4%。
本研究结果表明，第四代Elecsys HIV组合PT检测能够识别早期HIV感染，有助于临床医生通过病毒载量检测和启动适当治疗来管理该疾病。我们的研究数据为该地区后续研究和HIV检测提供了参考。
