Testing COVID-19 tests faces methodological challenges
Testing COVID-19 tests faces methodological challenges
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DOI：
10.1016/j.jclinepi.2020.06.037
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发表时间：
2020-10-01
影响因子：
7.2
通讯作者：
Bossuyt, Patrick M.
中科院分区：
文献类型：
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作者：
Bossuyt, Patrick M.
在抗击COVID-19大流行的过程中，检测至关重要。病毒RNA的检测允许识别感染者，而抗体的检测可能揭示对先前感染的反应。冠状病毒检测应在分析和临床表现方面进行严格评估。这不仅带来了逻辑上的挑战，也带来了方法论上的挑战。其中一些对于诊断准确性范例来说是通用的，而另一些对于病毒测试来说是更具体的。评估病毒RNA检测临床表现的问题在于缺乏独立的参考标准。许多研究在招募研究参与者方面缺乏严谨性。研究报告往往信息不足，这使得很难评估研究结果的适用性。试图根据对临床敏感性的单一估计来总结这些测试的性能，不能公正地对待产生假阴性结果的机制的巨大异质性的可识别来源。(C) 2020爱思唯尔公司版权所有。
In battling the COVID-19 pandemic, testing is essential. The detection of viral RNA allows the identification of infected persons, whereas the detection of antibodies may reveal a response to a previous infection. Tests for coronavirus should be rigorously evaluated in terms of their analytical and clinical performance. This poses not only logistic challenges, but also methodological ones. Some of these are generic for the diagnostic accuracy paradigm, whereas others are more specific for tests for viruses. Problematic for evaluations of the clinical performance of tests for viral RNA is the absence of an independent reference standard. Many studies lack rigor in terms of the recruitment of study participants. Study reports are often insufficiently informative, which makes it difficult to assess the applicability of study findings. Attempts to summarize the performance of these tests in terms of a single estimate of the clinical sensitivity fail to do justice to the identifiable sources of the large heterogeneity in mechanisms for generating false negative results. (C) 2020 Elsevier Inc. All rights reserved.