头对头比较快速床边 HIV 检测使用口腔与全血标本的准确性：系统评价和荟萃分析。

Head-to-head comparison of accuracy of a rapid point-of-care HIV test with oral versus whole-blood specimens: a systematic review and meta-analysis.

机构信息

Department of Medicine, Division of Clinical Epidemiology and Infectious Diseases, McGill University Health Center, Montreal, QC, Canada.

出版信息

Lancet Infect Dis. 2012 May;12(5):373-80. doi: 10.1016/S1473-3099(11)70368-1. Epub 2012 Jan 24.

DOI:10.1016/S1473-3099(11)70368-1

PMID:22277215

Abstract

BACKGROUND: The focus on prevention strategies aimed at curbing the HIV epidemic is growing, and therefore screening for HIV has again taken centre stage. Our aim was to establish whether a convenient, non-invasive, HIV test that uses oral fluid was accurate by comparison with the same test with blood-based specimens. METHODS: We did a systematic review and meta-analysis to compare the diagnostic accuracy of a rapid HIV-antibody-based point-of-care test (Oraquick advance rapid HIV-1/2, OraSure Technologies Inc, PA, USA) when used with oral versus blood-based specimens in adults. We searched five databases of published work and databases of five key HIV conferences. Studies we deemed eligible were those focused on adults at risk of HIV; we excluded studies in children, in co-infected populations, with self-reported inferior reference standards, and with incomplete reporting of key data items. We assessed the diagnostic accuracy of testing with oral and blood-based specimens with bivariate regression analysis. We computed positive predictive values (PPVs) in high-prevalence and low-prevalence settings with Bayesian methods. FINDINGS: In a direct head-to-head comparison of studies, we identified a pooled sensitivity about 2% lower in oral (98·03%, 95% CI 95·85-99·08) than in blood-based specimens (99·68%, 97·31-99·96), but similar specificity (oral 99·74%, 99·47-99·88; blood 99·91%, 99·84-99·95). Negative likelihood ratios were small and similar (oral 0·019, 0.009-0·040; blood 0·003, 0·001-0·034), but positive likelihood ratios differed (oral 383·37, 183·87-799·31; blood 1105·16, 633·14-2004·37). Although in high-prevalence settings PPVs were similar (oral 98·65%, 95% credible interval 85·71-99·94; blood 98·50, 93·10-99·79), in low-prevalence settings PPVs were lower for oral (88·55%, 77·31-95·87) than blood (97·65%, 95·48-99·09) specimens. INTERPRETATION: Although Oraquick had a high PPV in high-prevalence settings in oral specimens, the slightly lower sensitivity and PPV in low-prevalence settings in oral specimens should be carefully reviewed when planning worldwide expanded initiatives with this popular test.

摘要

背景：目前，预防策略的重点是遏制艾滋病的流行，因此艾滋病病毒的筛查再次成为焦点。我们的目的是确定一种方便、无创、使用口腔液的艾滋病病毒检测方法是否与基于血液的标本检测同样准确。

方法：我们进行了系统评价和荟萃分析，比较了在成年人中使用快速 HIV 抗体点检测（Oraquick 快速 HIV-1/2，OraSure Technologies Inc，宾夕法尼亚州，美国）时，口腔液和血液标本检测的诊断准确性。我们在五个已发表文献数据库和五个主要艾滋病病毒会议的数据库中进行了检索。我们认为符合条件的研究是针对有感染 HIV 风险的成年人进行的；我们排除了在儿童、合并感染人群中、自我报告的参考标准较差以及关键数据项报告不完整的研究。我们使用双变量回归分析评估了口腔和血液标本检测的诊断准确性。我们使用贝叶斯方法计算了高流行和低流行环境中的阳性预测值（PPV）。

结果：在直接对头对头研究的比较中，我们发现口腔标本的敏感性比血液标本低约 2%（口腔标本为 98.03%，95%CI 95.85-99.08；血液标本为 99.68%，97.31-99.96），但特异性相似（口腔标本为 99.74%，99.47-99.88；血液标本为 99.91%，99.84-99.95）。负似然比较小且相似（口腔标本为 0.019，0.009-0.040；血液标本为 0.003，0.001-0.034），但阳性似然比不同（口腔标本为 383.37，183.87-799.31；血液标本为 1105.16，633.14-2004.37）。虽然在高流行环境中，PPV 相似（口腔标本为 98.65%，95%置信区间为 85.71-99.94；血液标本为 98.50%，93.10-99.79%），但在低流行环境中，口腔标本的 PPV 较低（口腔标本为 88.55%，77.31-95.87%；血液标本为 97.65%，95.48-99.09%）。

结论：尽管 Oraquick 在口腔标本高流行环境中具有较高的 PPV，但在口腔标本低流行环境中，其敏感性和 PPV 略低，因此在计划在全球范围内推广这种广受欢迎的检测方法时，应仔细审查。