European Centre for Disease Prevention and Control, Stockholm, Sweden.
Centre for Infectious Disease Control, National Institute for Public Health and the Environment, The Netherlands.
Euro Surveill. 2021 Nov;26(45). doi: 10.2807/1560-7917.ES.2021.26.45.2001675.
BackgroundReliable testing for SARS-CoV-2 is key for the management of the COVID-19 pandemic.AimWe estimate diagnostic accuracy for nucleic acid and antibody tests 5 months into the COVID-19 pandemic, and compare with manufacturer-reported accuracy.MethodsWe reviewed the clinical performance of SARS-CoV-2 nucleic acid and antibody tests based on 93,757 test results from 151 published studies and 20,205 new test results from 12 countries in the European Union and European Economic Area (EU/EEA).ResultsPooling the results and considering only results with 95% confidence interval width ≤ 5%, we found four nucleic acid tests, including one point-of-care test and three antibody tests, with a clinical sensitivity ≥ 95% for at least one target population (hospitalised, mild or asymptomatic, or unknown). Nine nucleic acid tests and 25 antibody tests, 12 of them point-of-care tests, had a clinical specificity of ≥ 98%. Three antibody tests achieved both thresholds. Evidence for nucleic acid point-of-care tests remains scarce at present, and sensitivity varied substantially. Study heterogeneity was low for eight of 14 sensitivity and 68 of 84 specificity results with confidence interval width ≤ 5%, and lower for nucleic acid tests than antibody tests. Manufacturer-reported clinical performance was significantly higher than independently assessed in 11 of 32 and four of 34 cases, respectively, for sensitivity and specificity, indicating a need for improvement in this area.ConclusionContinuous monitoring of clinical performance within more clearly defined target populations is needed.
背景
可靠的 SARS-CoV-2 检测对于 COVID-19 大流行的管理至关重要。
目的
我们评估了 COVID-19 大流行 5 个月时核酸和抗体检测的诊断准确性，并与制造商报告的准确性进行了比较。
方法
我们根据来自 151 项已发表研究的 93757 项检测结果和来自欧盟和欧洲经济区（EU/EEA）12 个国家的 20205 项新检测结果，回顾了 SARS-CoV-2 核酸和抗体检测的临床性能。
结果
汇总结果并仅考虑置信区间宽度≤5%的结果，我们发现四种核酸检测，包括一种即时检测和三种抗体检测，在至少一种目标人群（住院、轻症或无症状或未知）中具有临床灵敏度≥95%。有 9 种核酸检测和 25 种抗体检测，其中 12 种为即时检测，具有临床特异性≥98%。三种抗体检测均达到了这两个阈值。目前，关于核酸即时检测的证据仍然很少，并且灵敏度差异很大。对于置信区间宽度≤5%的 14 项灵敏度和 84 项特异性结果中的 8 项和 68 项，研究异质性较低，核酸检测的异质性低于抗体检测。在灵敏度和特异性方面，制造商报告的临床性能分别在 32 项中的 11 项和 34 项中的 4 项中明显高于独立评估，表明在这方面需要改进。
结论
需要在更明确的目标人群中持续监测临床性能。
