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. ABSTRACT 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.
【저자키워드】 SARS-CoV-2, Influenza, RSV, Cepheid, flu, 4-plex, 【초록키워드】 COVID-19, public health, coronavirus, Microbiology, Influenza, Infection, influenza A virus, diagnostic, Diagnosis, Influenza virus, severe acute respiratory syndrome Coronavirus, virus, influenza A, Laboratory, Nasopharyngeal swab, nucleic acid, sensitivity, Surveillance, Accuracy, respiratory virus, respiratory syncytial virus, Cepheid, respiratory, nucleic acid amplification, USA, fusion, influenza B, nucleic acid amplification tests, Nasopharyngeal swab specimens, Johns Hopkins, Los Angeles, Medical Microbiology, influenza B virus, acute respiratory syndrome, acute respiratory syndrome coronavirus, acute respiratory syndrome coronavirus 2, DiaSorin, center, positive, nasopharyngeal swab specimen, RSV infections, Standard-of-care, Public, Direct, approach, tested, assays, evaluated, RSV infection, Hemisphere, Johns Hopkin, Los Angele, rapid diagnostic assay, the SARS-CoV-2, 【제목키워드】 Test,