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在社区筛查环境中,快速即时检测 SARS-CoV-2 的灵敏度较低。

Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity.

机构信息

Institute for Hygiene and Public Health, One Health Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.

Clinic for Internal Medicine, Infectious Diseases Department, Medical Faculty, University of Bonn, Venusberg-Campus 1, 53127 Bonn, Germany.

出版信息

Public Health. 2020 May;182:170-172. doi: 10.1016/j.puhe.2020.04.009. Epub 2020 Apr 18.

Abstract

OBJECTIVE

With the current SARS-CoV2 outbreak, countless tests need to be performed on potential symptomatic individuals, contacts and travellers. The gold standard is a quantitative polymerase chain reaction (qPCR)-based system taking several hours to confirm positivity. For effective public health containment measures, this time span is too long. We therefore evaluated a rapid test in a high-prevalence community setting.

STUDY DESIGN

Thirty-nine randomly selected individuals at a COVID-19 screening centre were simultaneously tested via qPCR and a rapid test. Ten previously diagnosed individuals with known SARS-CoV-2 infection were also analysed.

METHODS

The evaluated rapid test is an IgG/IgM-based test for SARS-CoV-2 with a time to result of 20 min. Two drops of blood are needed for the test performance.

RESULTS

Of 49 individuals, 22 tested positive by repeated qPCR. In contrast, the rapid test detected only eight of those positive correctly (sensitivity: 36.4%). Of the 27 qPCR-negative individuals, 24 were detected correctly (specificity: 88.9%).

CONCLUSION

Given the low sensitivity, we recommend not to rely on an antibody-based rapid test for public health measures such as community screenings.

摘要

目的

当前 SARS-CoV2 爆发,需要对数以千计的疑似症状个体、接触者和旅行者进行检测。金标准是基于定量聚合酶链反应(qPCR)的系统,需要数小时才能确认阳性。为了采取有效的公共卫生控制措施,这个时间跨度太长了。因此,我们在高发病率的社区环境中评估了一种快速检测方法。

研究设计

在 COVID-19 筛查中心随机选择了 39 名个体,同时通过 qPCR 和快速检测进行了检测。还对 10 名先前诊断出的已知 SARS-CoV-2 感染个体进行了分析。

方法

评估的快速检测是一种基于 IgG/IgM 的 SARS-CoV-2 检测方法,结果可在 20 分钟内获得。该检测需要两滴血进行。

结果

在 49 名个体中,有 22 名通过重复 qPCR 检测呈阳性。相比之下,快速检测仅正确检测到其中的 8 例(敏感性:36.4%)。在 27 名 qPCR 阴性个体中,有 24 例被正确检测到(特异性:88.9%)。

结论

鉴于敏感性较低,我们建议不要依赖基于抗体的快速检测来进行公共卫生措施,如社区筛查。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fbe8/7165286/30dfe9392e13/gr1_lrg.jpg

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