False-negative results of initial RT-PCR assays for COVID-19: A systematic review.
False-negative results of initial RT-PCR assays for COVID-19: A systematic review.
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DOI：
10.1371/journal.pone.0242958
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发表时间：
2020
期刊：
影响因子：
3.7
通讯作者：
Zamora J
中科院分区：
文献类型：
--
作者：
Arevalo-Rodriguez I;Buitrago-Garcia D;Simancas-Racines D;Zambrano-Achig P;Del Campo R;Ciapponi A;Sued O;Martinez-García L;Rutjes AW;Low N;Bossuyt PM;Perez-Molina JA;Zamora J
严重急性呼吸综合征冠状病毒2型（SARS-CoV-2）感染的假阴性病例定义为疑似感染的人，逆转录聚合酶链反应（RT-PCR）检测最初结果为阴性，随后的检测结果为阳性。假阴性病例对隔离和感染者的传播风险以及2019冠状病毒病（COVID-19）的管理具有重要意义。我们的目的是审查和批判性地评估有关COVID-19初始检测时RT-PCR假阴性率的证据。我们检索了MEDLINE、EMBASE、LILACS以及COVID-19存储库，包括EPPI中心关于COVID-19的活体证据系统地图和冠状病毒开放获取项目活体证据数据库。两位作者根据入选标准独立筛选和选择研究，并从纳入的研究中收集数据。使用诊断准确性研究质量评估（QUADAS-2）工具评估偏倚风险。我们使用多水平混合效应逻辑回归模型计算假阴性测试结果的比例。使用GRADE方法对关于假阴性病例的证据的确定性进行测试和策略评级。本文中的所有信息均截至2020年7月17日。我们纳入了34项研究，纳入了12，057例COVID-19确诊病例。所有研究都受到偏倚和适用性问题的影响。假阴性比例的合并估计值受到不明原因异质性的高度影响（τ平方= 1.39; 90%预测区间为0.02 - 0.54）。由于偏倚、间接性和不一致性问题的风险，证据的确定性被判定为非常低。在假阴性RT-PCR结果的比例中存在大量且无法解释的异质性。所收集的证据有几个局限性，包括偏倚问题的风险、高度异质性以及对其适用性的担忧。尽管如此，我们的研究结果加强了对疑似SARS-Cov-2感染患者进行重复检测的必要性，因为高达54%的COVID-19患者可能具有初始假阴性RT-PCR（证据的确定性非常低）。协议可在OSF网站上获得：https://tinyurl.com/vvbgqya。
A false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for isolation and risk of transmission of infected people and for the management of coronavirus disease 2019 (COVID-19). We aimed to review and critically appraise evidence about the rate of RT-PCR false-negatives at initial testing for COVID-19. We searched MEDLINE, EMBASE, LILACS, as well as COVID-19 repositories, including the EPPI-Centre living systematic map of evidence about COVID-19 and the Coronavirus Open Access Project living evidence database. Two authors independently screened and selected studies according to the eligibility criteria and collected data from the included studies. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the proportion of false-negative test results using a multilevel mixed-effect logistic regression model. The certainty of the evidence about false-negative cases was rated using the GRADE approach for tests and strategies. All information in this article is current up to July 17, 2020. We included 34 studies enrolling 12,057 COVID-19 confirmed cases. All studies were affected by several risks of bias and applicability concerns. The pooled estimate of false-negative proportion was highly affected by unexplained heterogeneity (tau-squared = 1.39; 90% prediction interval from 0.02 to 0.54). The certainty of the evidence was judged as very low due to the risk of bias, indirectness, and inconsistency issues. There is substantial and largely unexplained heterogeneity in the proportion of false-negative RT-PCR results. The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability. Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection given that up to 54% of COVID-19 patients may have an initial false-negative RT-PCR (very low certainty of evidence). Protocol available on the OSF website: https://tinyurl.com/vvbgqya.
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