Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting.
Evaluation of two rapid antigen tests to detect SARS-CoV-2 in a hospital setting.
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两种快速抗原检测方法在医院检测SARS-CoV-2的评价
DOI：
10.1007/s00430-020-00698-8
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发表时间：
2021-03
影响因子：
5.4
通讯作者：
Keppler OT
中科院分区：
文献类型：
--
作者：
Osterman A;Baldauf HM;Eletreby M;Wettengel JM;Afridi SQ;Fuchs T;Holzmann E;Maier A;Döring J;Grzimek-Koschewa N;Muenchhoff M;Protzer U;Kaderali L;Keppler OT
SARS-CoV-2大流行的成功控制战略将取决于可靠的诊断分析。即时抗原检测（POCT）可以替代耗时的PCR检测，在现场快速筛查急性感染。在这里，我们评估了两种SARS-CoV-2抗原检测方法：STANDARD™F COVID-19 Ag FIA （FIA）和SARS-CoV-2快速抗原检测（RAT）。为了进行诊断评估，我们在德国慕尼黑的两所大学医院（即急诊室、患者护理单位或员工测试中心）使用了大量来自无症状和有症状患者和卫生保健工作者的pcr阳性和pcr阴性呼吸道拭子。FIA的总体临床敏感性和特异性分别为45.4% （n = 381）和97.8% (n = 360)， RAT的总体临床敏感性和特异性分别为50.3% （n = 445）和97.7% （n = 386）。对于无症状和有症状个体的初步诊断，诊断敏感性分别为60.9% (FIA) （n = 189）和64.5% (RAT) （n = 256）。这就质疑了这些检测对于可靠检测急性sars - cov -2感染者的效用，特别是在高风险环境中。我们支持需要在POCT环境中获得关于假阴性和假阳性抗原检测结果影响的令人信服的高质量结局数据的建议。此外，在国家和国际测试策略中广泛实施之前，必须由独立实验室评估补充PCR分析的替代测试策略的有效性。
Successful containment strategies for the SARS-CoV-2 pandemic will depend on reliable diagnostic assays. Point-of-care antigen tests (POCT) may provide an alternative to time-consuming PCR tests to rapidly screen for acute infections on site. Here, we evaluated two SARS-CoV-2 antigen tests: the STANDARD™ F COVID-19 Ag FIA (FIA) and the SARS-CoV-2 Rapid Antigen Test (RAT). For diagnostic assessment, we used a large set of PCR-positive and PCR-negative respiratory swabs from asymptomatic and symptomatic patients and health care workers in the setting of two University Hospitals in Munich, Germany, i.e. emergency rooms, patient care units or employee test centers. For FIA, overall clinical sensitivity and specificity were 45.4% (n = 381) and 97.8% (n = 360), respectively, and for RAT, 50.3% (n = 445) and 97.7% (n = 386), respectively. For primary diagnosis of asymptomatic and symptomatic individuals, diagnostic sensitivities were 60.9% (FIA) (n = 189) and 64.5% (RAT) (n = 256). This questions these tests’ utility for the reliable detection of acute SARS-CoV-2-infected individuals, in particular in high-risk settings. We support the proposal that convincing high-quality outcome data on the impact of false-negative and false-positive antigen test results need to be obtained in a POCT setting. Moreover, the efficacy of alternative testing strategies to complement PCR assays must be evaluated by independent laboratories, prior to widespread implementation in national and international test strategies.
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影响因子：
19
作者：
Singanayagam, Anika;Patel, Monika;Gopal, Robin
通讯作者：
Gopal, Robin
影响因子：
9.4
作者：
Young S;Taylor SN;Cammarata CL;Varnado KG;Roger-Dalbert C;Montano A;Griego-Fullbright C;Burgard C;Fernandez C;Eckert K;Andrews JC;Ren H;Allen J;Ackerman R;Cooper CK
通讯作者：
Cooper CK
DOI：
10.1016/j.cmi.2020.09.057
发表时间：
2021-03
期刊：
Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases
影响因子：
--
作者：
Diao B;Wen K;Zhang J;Chen J;Han C;Chen Y;Wang S;Deng G;Zhou H;Wu Y
通讯作者：
Wu Y
DOI：
10.1016/j.jcv.2020.104412
发表时间：
2020-07-01
期刊：
Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology
影响因子：
--
作者：
van Kasteren, Puck B;van der Veer, Bas;Meijer, Adam
通讯作者：
Meijer, Adam
影响因子：
19
作者：
Konrad, Regina;Eberle, Ute;Sing, Andreas
通讯作者：
Sing, Andreas