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SARS-CoV-2感染的假阴性检测结果——挑战和影响
False Negative Tests for SARS-CoV-2 Infection — Challenges and Implications


Steven Woloshin ... 呼吸系统疾病 • 2020.08.06
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广泛检测SARS-CoV-2对于美国安全重新开放经济活动至关重要,这一点已形成广泛共识。尽管检测试剂盒的供应一直是一个大问题,但检测结果的准确性可能是一个更大的长期问题。

人们争论的焦点一直集中在用于识别既往感染SARS-CoV-2的抗体检测准确性上,而用于识别当前感染的诊断性检测(译者注:除诊断性检测外,还有筛查性检测)却较少受到关注。不准确的诊断性检测结果会削弱我们在遏制大流行方面做出的努力。

诊断性检测(在美国通常为鼻咽拭子)的不准确结果分为两种。假阳性结果将非感染者错误标记为感染者,其后果包括不必要的隔离观察和接触者追踪。假阴性结果的后果则更为严重,因为感染者(可能无症状)可能因未被隔离而传染其他人。

我们需要了解诊断性检测排除感染的性能,因此有必要总结美国食品药品管理局(FDA)和临床研究人员对检测准确性所做的评估,以及对大流行中检测结果的解读。





作者信息

Steven Woloshin, M.D., Neeraj Patel, B.A., and Aaron S. Kesselheim, M.D., J.D., M.P.H.
From the Center for Medicine in the Media, Dartmouth Institute for Health Policy and Clinical Practice, Lebanon, NH (S.W.); the Lisa Schwartz Program for Truth in Medicine, Norwich, VT (S.W.); the Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston (S.W., A.K.); and Yale University, New Haven, CT (N.P.).

 

参考文献

1. U.S. Food and Drug Administration. Emergency Use Authorization (EUA) information, and list of all current EUAs (https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. opens in new tab).

2. Yang Y, Yang M, Shen C, et al. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections. February 17, 2020 (https://www.medrxiv.org/content/10.1101/2020.02.11.20021493v2. opens in new tab). preprint.

3. Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis 2020 March 28 (Epub ahead of print).

4. Arevalo-Rodriguez I, Buitrago-Garcia D, Simancas-Racines D, et al. False-negative results of initial RT-PCR assays for COVID-19: a systematic review. April 21, 2020 (https://www.medrxiv.org/content/10.1101/2020.04.16.20066787v1. opens in new tab). preprint.

5. Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ 2020;369:m1808-m1808.

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