基于血液的抗体快速检测用于HIV早期治疗的评估：证据的荟萃分析

Evaluation of Blood-Based Antibody Rapid Testing for HIV Early Therapy: A Meta-Analysis of the Evidence.

作者信息

Huang Xiaojie, Liu Xinchao, Chen Jieqing, Bao Yugang, Hou Jianhua, Lu Xiaofan, Xia Wei, Xia Huan, Song Aixin, Liu Zhiying, Su Bin, Chen Hui, Chen Yaokai, Wu Hao

机构信息

Center for Infectious Diseases, Beijing You'an Hospital, Capital Medical University, Beijing, China.

Department of Infectious Diseases, Peking Union Medical College Hospital, Beijing, China.

出版信息

Front Immunol. 2018 Jun 26;9:1458. doi: 10.3389/fimmu.2018.01458. eCollection 2018.

DOI:10.3389/fimmu.2018.01458

PMID:30013552

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6036269/

Abstract

BACKGROUND

Western blot (WB) assay is considered the gold standard test for HIV infection confirmation. However, it requires technical expertise and is quite time-consuming. WHO recommends blood-based rapid diagnosis to achieve same-day test and treatment. However, this rapid testing strategy has not been promoted worldwide due to inadequate research evaluating the effectiveness of rapid tests (RTs) as an alternative confirmatory HIV test for WB. This study aims to compare the diagnostic performance of rapid HIV tests compared with WB.

METHODS

PubMed and Web of Science were searched for publications on rapid HIV tests using blood specimen. A meta-analysis was performed to quantitatively evaluate the diagnostic performance of rapid HIV tests compared with the WB assay in terms of pooled sensitivity, specificity, area under summary receiver operating characteristic (SROC) curve, and diagnostic odds ratio (DOR).

RESULTS

Twenty articles involving 27,343 fresh specimens for rapid HIV tests were included in the meta-analysis. Regarding Capillus HIV-1/HIV-2, the pooled sensitivity, specificity, area under SROC curve, and DOR derived from six studies were 0.999 (95% CI, 0.956-1.000), 0.999 (95% CI, 0.991-1.00), 1.00 (95% CI, 0.99-1.00), and 1.0 × 10 (95% CI, 2.6 × 10-3.9 × 10) compared with the WB assay, respectively. With respect to Determine HIV-1/2, the pooled sensitivity, specificity area under SROC, and DOR derived from eight studies were 1.00 (95% CI, 0.789-1.000), 0.992 (95% CI, 0.985-0.996), 1.00 (95% CI, 0.99-1.00), and 1.8 × 10 (95% CI 406.049-7.8 × 10) compared with the WB assay, respectively. Regarding two-step serial RTs, the pooled sensitivity, specificity area under SROC, and DOR derived from eight studies were 0.998 (95% CI, 0.991-1.000), 0.998 (95% CI, 0.994-0.999), and 1.00 (95% CI 0.99-1.00) compared with the WB assay, respectively.

CONCLUSION

Our meta-analysis results may provide evidenced-based support for substituting RT for WB. Blood-based rapid HIV tests have comparable sensitivity and specificity to WB for HIV early therapy.

摘要

背景

蛋白质印迹法（WB）检测被认为是确认HIV感染的金标准检测方法。然而，它需要专业技术知识且相当耗时。世界卫生组织建议采用基于血液的快速诊断方法以实现当日检测和治疗。然而，由于评估快速检测（RT）作为WB替代确证性HIV检测有效性的研究不足，这种快速检测策略尚未在全球范围内得到推广。本研究旨在比较快速HIV检测与WB的诊断性能。

方法

在PubMed和Web of Science上搜索关于使用血液标本进行快速HIV检测的出版物。进行荟萃分析以定量评估快速HIV检测与WB检测相比在合并敏感性、特异性、汇总接受者操作特征（SROC）曲线下面积和诊断比值比（DOR）方面的诊断性能。

结果

荟萃分析纳入了20篇涉及27343份用于快速HIV检测的新鲜标本的文章。对于Capillus HIV-1/HIV-2，六项研究得出的合并敏感性、特异性、SROC曲线下面积和DOR与WB检测相比分别为0.999（95%CI，0.956 - 1.000）、0.999（95%CI，0.991 - 1.00）、1.00（95%CI，0.99 - 1.00）和1.0×10（95%CI，2.6×10 - 3.9×10）。对于Determine HIV-1/2，八项研究得出的合并敏感性、特异性、SROC曲线下面积和DOR与WB检测相比分别为1.00（95%CI，0.789 - 1.000）、0.992（95%CI，0.985 - 0.996）、1.00（95%CI，0.99 - 1.00）和1.8×10（95%CI 406.049 - 7.8×10）。对于两步串联RT，八项研究得出的合并敏感性、特异性、SROC曲线下面积和DOR与WB检测相比分别为0.998（95%CI，0.991 - 1.000）、0.998（95%CI，0.994 - 0.999）和1.00（95%CI 0.99 - 1.00）。