Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test.
Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test.
复制标题
Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV 检测的多中心评估。
DOI：
10.1128/jcm.02955-20
复制
发表时间：
2021-02-18
影响因子：
9.4
通讯作者：
Loeffelholz MJ
中科院分区：
文献类型：
--
作者：
Mostafa HH;Carroll KC;Hicken R;Berry GJ;Manji R;Smith E;Rakeman JL;Fowler RC;Leelawong M;Butler-Wu SM;Quintero D;Umali-Wilcox M;Kwiatkowski RW;Persing DH;Weir F;Loeffelholz MJ
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综合征冠状病毒2型（SARS-CoV-2）与流感病毒和呼吸道合胞病毒（RSV）感染，以便进行诊断和监测。本研究在四个中心评估了Xpert Xpress SARS-CoV-2/Flu/RSV检测（Cepheid, Sunnyvale， CA， USA）用于鼻咽拭子标本的临床性能：约翰霍普金斯医学微生物学实验室、Northwell卫生实验室、纽约市公共卫生实验室和洛杉矶县/南加州大学（LAC+USC）医学中心。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综合征冠状病毒2型（SARS-CoV-2）与流感病毒和呼吸道合胞病毒（RSV）感染，以便进行诊断和监测。本研究在四个中心评估了Xpert Xpress SARS-CoV-2/Flu/RSV检测（Cepheid, Sunnyvale， CA， USA）用于鼻咽拭子标本的临床性能：约翰霍普金斯医学微生物学实验室、Northwell卫生实验室、纽约市公共卫生实验室和洛杉矶县/南加州大学（LAC+USC）医学中心。采用造父变星平板试验对各站点经标准护理核酸扩增试验呈SARS-CoV-2阳性（n = 75）、甲型流感病毒（n = 65）、乙型流感病毒（n = 50）、RSV病毒（n = 38）或阴性（n = 91）的319份鼻咽拭子标本进行检测。SARS-CoV-2目标的总体阳性百分比一致性为98.7% (n = 74/75)，阴性百分比一致性为100% (n = 91)，所有其他分析结果显示100%的总一致性（n = 153）。与造父变星检测组进行比较的标准检测包括：Cepheid Xpert Xpress SARS-CoV-2、Cepheid Xpert Xpress Flu/RSV、GenMark ePlex呼吸检测组、BioFire呼吸检测组2.1和v1.7、DiaSorin Simplexa covid - Direct和Hologic Panther Fusion SARS-CoV-2检测。Xpert Xpress SARS-CoV-2/Flu/RSV检测对检测中所有分析物均显示出高灵敏度和准确性。在当前的呼吸道病毒季节，该检测将为检测和区分SARS-CoV-2、甲型和乙型流感病毒以及呼吸道合胞病毒感染提供有价值的临床诊断和公共卫生解决方案。
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. 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.