Lancet子刊:头对头对比口腔和血液中HIV检测,慎用口腔检测方法

2012-02-06 MedSci 医学论坛网

2012年1月25日,来自加拿大蒙特利尔市的McGill大学医学系和McGill大学健康中心临床流行病学和感染性疾病部医学博士Nitika Pant Pai和他的同事利用一篇最新综述中收集的数据进行荟萃分析,结果表明:与基于血液的检测方法相比,口腔HIV诊断具有相似的特异性,而敏感性要低2%。这些研究结果于1月24日在线发表于《柳叶刀·传染病学》杂志。 与此相似,在高流行环境中,口腔检测(Ora

2012年1月25日,来自加拿大蒙特利尔市的McGill大学医学系和McGill大学健康中心临床流行病学和感染性疾病部医学博士Nitika Pant Pai和他的同事利用一篇最新综述中收集的数据进行荟萃分析,结果表明:与基于血液的检测方法相比,口腔HIV诊断具有相似的特异性,而敏感性要低2%。这些研究结果于1月24日在线发表于《柳叶刀·传染病学》杂志。

与此相似,在高流行环境中,口腔检测(OraQuick, OraSure)的阳性预测值(PPV)比较高(98.65;95%置信区间为85.71% - 99.94%),与相同条件下血液检测的PPV(98.5%,95%置信区间为93.10 - 99.79)相当。然而,在低流行环境中,口腔检测的PPV (88.55%;95% 置信区间为 77.31% - 95.87%)比血液样品检测的PPV(97.65%;95%置信区间为95.48% - 99.09%)低。在考虑全球推广这种时髦的口腔检测时,两种检测结果的差异应当进行考虑。

该研究的作者指出:虽然口腔检测的特异性与制造商声称的比较相似,但是,在灵敏度上达不到他们的宣传。

在随后的评论中,来自中国香港大学的医学博士Chi Chiu Leung和Shui Shan Lee描述了该研究对临床应用的意义:“由于唾液的Oraquick方法更加方便,而且是非侵入性的,因此,这种方法比较有吸引力。虽然该方法的易接受性可能促进HIV的筛查,但是却造成了相当高的假阳性率。虽然估计特异性达到了99.74%,但是仍然比目前使用的大多数检测方法低。这一点在解释检测结果时必须考虑在内,在对低风险群体的检测中尤其应当注意。”

该社论作者解释说:口腔样品检测中得到的低PPV在低流行环境(HIV < 1%)中应当尤其注意。他们也强调了PPV值的重要性,这是因为PPV值与临床医生的关系更加紧密。PPV提供了检测结果为阳性时,患者真正患HIV的概率。

因此,虽然口腔检测是高度特异的,但是在HIV患病率低于1%时,口腔检测与基于血液的检测方法的细微差别将会变得不容忽视。基于口腔疗法的PPV 比较低,Leung博士和Lee博士不赞成这类方法的快速推广。他们特别指出确证实验(包括阳性结果和阴性结果)对于HIV之类的重大疾病是非常重要的。重复检测会降低人们对口腔检测具有低PPV的担心。

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

Dr Nitika Pant Pai MD a , Bhairavi Balram BSc a, Sushmita Shivkumar MSc a, Jorge Luis Martinez-Cajas MD b, Christiane Claessens PhD c, Gilles Lambert MD c d, Prof Rosanna W Peeling PhD e, Prof Lawrence Joseph PhD f

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-prevelence 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.

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    2012-03-14 howi
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