Abstract：
This study evaluates the performance of the QIAstat-Dx Respiratory SARS-CoV-2 Panel (RS2P) for the detection of respiratory pathogens. RS2P testing was performed on 440 specimens, including 82 negatives and 358 specimens positive for 1 or more targets (520 targets initially detected). Initial testing was performed on multiple platforms during routine laboratory workflow. Specimens with discordant results on RS2P were re-tested on a different platform to obtain a consensus result based on agreement of 2/3 assays. Percent positive, negative and overall agreement (PPA, PNA, POA), as well as concordance by number of targets and CT value range were calculated. RS2P produced valid results in 439 specimens, with a POA of 91.5 % based on consensus results, with 16/31 (51.6 %) discordant specimens with >1 positive target. When individual targets were examined, PPA, PNA and POA were 93.7 %, 99.9 % and 99.6 % compared to consensus results. Overall, RS2P performed well in detection of respiratory pathogens.
摘要：
本研究评估了QIAstat-Dx呼吸道SARS-CoV-2小组（RS2P）检测呼吸道病原体的性能。对440个样本进行了RS2P测试，包括82个阴性和358个标本对1个或多个目标呈阳性（最初检测到520个目标）。在常规实验室工作流程期间在多个平台上进行初始测试。在不同的平台上重新测试在RS2P上具有不一致结果的样本,以基于2/3测定的一致性获得一致结果。正百分比，消极和总体协议(PPA，PNA,POA),计算了目标数量和CT值范围的一致性。RS2P在439个样本中产生了有效的结果，基于共识结果，POA为91.5%，16/31（51.6%）不一致标本>1阳性目标。当单个目标被检查时，PPA,PNA和POA分别为93.7%,与共识结果相比，99.9%和99.6%。总的来说,RS2P在呼吸道病原体检测中表现良好。
