Department of Microbiology, Government Medical College, Jammu, 180001, Jammu and Kashmir, India.
Arch Microbiol. 2022 Jul 19;204(8):502. doi: 10.1007/s00203-022-03118-y.
Fast and reliable testing for the COVID 19 infection is the need of the hour for the development of effective and reliable tools and assays. However, it is difficult to find the performance relativity among all these tests which are poorly understood. In this study, we aimed to evaluate the two different platforms where we determine the difference of sensitivity and specificity between the fully automated analyzer (Roche Diagnostics Cobas 6800 SARS-CoV-2 test) under FDA Emergency Use Authorization (EUA) and the laboratory designed test (SARS-CoV-2 rRT-PCR) based on the protocol developed by ICMR (Indian Council for Medical Research). The study was conducted for individual samples. We performed our study with two different approaches, first with validation method consisting of 188 samples (2 batches) on cobas 6800 instrument (Roche Molecular Systems, Branchburg, NJ) soon after we received US FDA EUA on 1 June 2021, all these samples were tested earlier with laboratory designed tests on 25th and 26th May 2021. Over all agreement between the two tests is of 88% and the coefficient of agreement between the two testing platform Cohen'sκ coefficient was found to be 0.76 (95% CI, 2.5897-13.4103) suggesting the substantial agreement between the two platforms. However, in some of the cases, both tests have shown a little disagreement. An overall discordance rate between two systems was found 11.1%. The difference may be due to the limit of detection, variation in the sequences of the primer design or may be due to other factors depicting the importance of comparing the two platforms used in the testing for SARS-CoV-2. Second approach includes head to head evaluation which comprises 1631 samples showed overall agreement of 99% and kappa value of 0.98. These results showed that cobas is effective and reliable assay for the detection of SARS-CoV-2 infection.
快速可靠的 COVID-19 感染检测是开发有效可靠工具和检测方法的当务之急。然而，由于对这些检测方法的性能相关性了解甚少，因此很难找到它们之间的相关性。在这项研究中，我们旨在评估两个不同的平台，我们根据 ICMR（印度医学研究理事会）制定的方案，确定了在 FDA 紧急使用授权 (EUA) 下的全自动分析仪（罗氏诊断 Cobas 6800 SARS-CoV-2 检测）和实验室设计检测（SARS-CoV-2 rRT-PCR）之间的灵敏度和特异性差异。该研究针对个体样本进行。我们采用了两种不同的方法进行研究，首先是在 2021 年 6 月 1 日我们获得美国 FDA EUA 后不久，使用包含 188 个样本（2 个批次）的验证方法在 cobas 6800 仪器（罗氏分子系统，新泽西州布兰奇堡）上进行研究，所有这些样本都在 2021 年 5 月 25 日和 26 日使用实验室设计的检测方法进行了早期测试。两种检测方法之间的总一致性为 88%，两种检测平台之间的一致性系数 Cohen'sκ 系数为 0.76（95%CI，2.5897-13.4103），表明两种平台之间具有高度一致性。然而，在某些情况下，两种检测方法都显示出了一些差异。两种系统之间的总不一致率为 11.1%。这种差异可能是由于检测限的限制、引物设计序列的变化，或者可能是由于其他因素，这些因素表明比较 SARS-CoV-2 检测中使用的两种平台的重要性。第二种方法包括头对头评估，其中包括 1631 个样本，总一致性为 99%，kappa 值为 0.98。这些结果表明 cobas 是一种有效的 SARS-CoV-2 感染检测方法。
