With the approach of respiratory virus season in the Northern Hemisphere, clinical microbiology and public health laboratories will need rapid diagnostic assays to distinguish severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from influenza virus and respiratory syncytial virus (RSV) infections for diagnosis and surveillance. In this study, the clinical performance of the Xpert Xpress SARS-CoV-2/Flu/RSV test (Cepheid, Sunnyvale, CA, USA) for nasopharyngeal swab specimens was evaluated in four centers: Johns Hopkins Medical Microbiology Laboratory, Northwell Health Laboratories, NYC Public Health Laboratory, and Los Angeles County/University of Southern California (LAC+USC) Medical Center. A total of 319 nasopharyngeal swab specimens, positive for SARS-CoV-2 (n = 75), influenza A virus (n = 65), influenza B virus (n = 50), or RSV (n = 38) or negative (n = 91) by the standard-of-care nucleic acid amplification tests at each site, were tested using the Cepheid panel test. The overall positive percent agreement for the SARS-CoV-2 target was 98.7% (n = 74/75), and the negative agreement was 100% (n = 91), with all other analytes showing 100% total agreement (n = 153). Standard-of-care tests to which the Cepheid panel was compared included the Cepheid Xpert Xpress SARS-CoV-2, Cepheid Xpert Xpress Flu/RSV, GenMark ePlex respiratory panel, BioFire respiratory panel 2.1 and v1.7, DiaSorin Simplexa COVID-19 Direct, and Hologic Panther Fusion SARS-CoV-2 assays. The Xpert Xpress SARS-CoV-2/Flu/RSV test showed high sensitivity and accuracy for all analytes included in the test. This test will provide a valuable clinical diagnostic and public health solution for detecting and differentiating SARS-CoV-2, influenza A and B virus, and RSV infections during the current respiratory virus season.

中文翻译：

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造父变星Xpress SARS-CoV-2 / Flu / RSV测试的多中心评估

随着北半球呼吸道病毒季节的临近，临床微生物学和公共卫生实验室将需要快速诊断分析以区分严重急性呼吸道综合症冠状病毒2（SARS-CoV-2）与流感病毒和呼吸道合胞病毒（RSV）感染，诊断和监视。在这项研究中，Xpert Xpress SARS-CoV-2 / Flu / RSV测试（Cepheid，Sunnyvale，CA，美国）在四个中心对鼻咽拭子标本的临床表现进行了评估：Johns Hopkins医学微生物学实验室，Northwell Health Laboratories，纽约市公共卫生实验室和洛杉矶县/南加州大学（LAC + USC）医疗中心。总共319份鼻咽拭子标本，SARS-CoV-2阳性（n = 75），甲型流感病毒（n = 65），乙型流感病毒（n = 50）或RSV（n = 38）或阴性（n = 91）在每个站点通过护理标准核酸扩增测试进行了检测，使用Cepheid面板测试。SARS-CoV-2目标的总体阳性阳性率为98.7％（n = 74/75），阴性阴性率为100％（n = 91），所有其他分析物均显示100％的总体一致性（n= 153）。与Cepheid面板进行比较的标准护理测试包括Cepheid Xpert Xpress SARS-CoV-2，Cephedid Xpert Xpress Flu / RSV，GenMark ePlex呼吸面板，BioFire呼吸面板2.1和v1.7，DiaSorin Simplexa COVID-19直接和Hologic Panther Fusion SARS-CoV-2分析。Xpert Xpress SARS-CoV-2 / Flu / RSV测试对测试中包括的所有分析物显示出高灵敏度和准确性。该测试将提供有价值的临床诊断和公共卫生解决方案，用于在当前呼吸道病毒季节检测和区分SARS-CoV-2，甲型和乙型流感病毒以及RSV感染。