LaboratoryDiagnostic CEnter, University Hospital RWTH Aachen, Germany.
Department of Pneumology and Intensive Care Medicine, University Hospital RWTH Aachen, Germany.
J Virol Methods. 2021 Feb;288:114024. doi: 10.1016/j.jviromet.2020.114024. Epub 2020 Nov 20.
There is an ongoing need for reliable antigen assays for timely and easy detection of individuals with acute SARS-CoV-2 infection. Using 75 swabs from patients previously tested positive by SARS-CoV-2 PCR and 75 swabs from patients previously tested negative by SARS-CoV-2 PCR, we investigated the sensitivity and specificity of the SARS-CoV-2 Rapid Antigen Test (Roche). We determined a specificity of 96 %. The assay's sensitivity with samples with a cycle threshold of < 25, 25 - <30, 30 - <35, and> = 35 was 100 %, 95 %, 44.8 % and 22.2 %, respectively. We conclude that sensitivity and specificity of the antigen assay is inferior to the PCR assay. However, the antigen assay may be a quick and easy to perform alternative for differentiation of individuals contagious for SARS-CoV-2 from non-contagious individuals.
目前仍需要可靠的抗原检测方法,以便及时、轻松地检测出急性 SARS-CoV-2 感染的个体。我们使用了 75 份先前经 SARS-CoV-2 PCR 检测阳性的患者拭子和 75 份先前经 SARS-CoV-2 PCR 检测阴性的患者拭子,研究了 SARS-CoV-2 快速抗原检测(罗氏)的灵敏度和特异性。我们确定了 96%的特异性。对于循环阈值<25、25-<30、30-<35 和>=35 的样本,该检测的灵敏度分别为 100%、95%、44.8%和 22.2%。我们得出结论,抗原检测的灵敏度和特异性不如 PCR 检测。然而,抗原检测可能是一种快速、简便的方法,可以区分具有 SARS-CoV-2 传染性的个体和非传染性个体。