Department of Clinical Virology, Institute of Liver & Biliary Sciences, New Delhi, India.
Department of Microbiology and Infection Control, Max Super Speciality Hospital, New Delhi, India.
J Virol Methods. 2021 Dec;298:114300. doi: 10.1016/j.jviromet.2021.114300. Epub 2021 Sep 22.
The QIAstat-Dx SARS-CoV-2 panel is a multiplex cartridge based assay based on real time PCR which can detect 17 respiratory viruses, including the novel coronavirus SARS-CoV-2. A syndromic approach is the need of the hour for COVID-19 diagnostics among patients presenting with respiratory symptoms. The present study was done to evaluate 120 archived respiratory clinical specimens for SARS-CoV-2 on the SARS-CoV-2 panel. Further, 27 specimens were tested for other respiratory viruses, in comparison with the BioFire RP1.7 platform. The sensitivity and specificity for SARS-CoV-2 on SARS panel was found to be 90.00 % and 100 % respectively, indicating good diagnostic accuracy. The positive predictive value was found to be 100 %, negative predictive value was found to be 99.93 % and accuracy was 99.93 %. Detection of other respiratory viruses observed a concordance of 77.7 %. Despite advantages of speed, minimal expertise and accurate results; significant costs and discrepancies at Ct >35 remain important limitations of the SARS panel.
QIAstat-Dx SARS-CoV-2 检测试剂盒是一种基于实时 PCR 的多重检测试剂盒,可检测 17 种呼吸道病毒,包括新型冠状病毒 SARS-CoV-2。对于出现呼吸道症状的 COVID-19 患者,采用综合征方法进行诊断是当务之急。本研究旨在评估 SARS-CoV-2 检测试剂盒对 120 份存档呼吸道临床标本中 SARS-CoV-2 的检测情况。此外,还与 BioFire RP1.7 平台比较,对 27 份标本进行了其他呼吸道病毒的检测。SARS 检测试剂盒检测 SARS-CoV-2 的灵敏度和特异性分别为 90.00%和 100%,表明具有良好的诊断准确性。阳性预测值为 100%,阴性预测值为 99.93%,准确率为 99.93%。检测其他呼吸道病毒的结果显示,一致性为 77.7%。尽管 SARS 检测试剂盒具有速度快、所需专业知识少、结果准确等优点,但 Ct 值>35 时的高成本和差异仍然是该试剂盒的重要局限性。