Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV Test

被引：65

作者：

Mostafa, Heba H. ^{[1
]}

Carroll, Karen C. ^{[1
]}

Hicken, Rachel ^{[1
]}

Berry, Gregory J. ^{[2
]}

Manji, Ryhana ^{[2
]}

Smith, Elizabeth ^{[2
]}

Rakeman, Jennifer L. ^{[3
]}

Fowler, Randal C. ^{[3
]}

Leelawong, Mindy ^{[3
]}

Butler-Wu, Susan M. ^{[4
]}

Quintero, David ^{[4
]}

Umali-Wilcox, Minette ^{[4
]}

Kwiatkowski, Robert W. ^{[5
]}

Persing, David H. ^{[5
]}

Weir, Fred ^{[5
]}

Loeffelholz, Michael J. ^{[5
]}

机构：

[1] Johns Hopkins Univ, Sch Med, Baltimore, MD USA

[2] Zucker SOM Hofstra Northwell, Northwell Hlth Labs, East Garden City, NY USA

[3] NYC Publ Hlth Lab, Dept Hlth & Mental Hyg, New York, NY USA

[4] Keck Sch Med USC, Dept Pathol, Los Angeles, CA USA

[5] Cepheid, Sunnyvale, CA 94089 USA

来源：

JOURNAL OF CLINICAL MICROBIOLOGY | 2021年 / 59卷 / 03期

关键词：

Cepheid; SARS-CoV-2; influenza; flu; RSV; 4-plex; INFLUENZA-VIRUS;

D O I：

10.1128/JCM.02955-20

中图分类号：

Q93 [微生物学];

学科分类号：

071005 ; 100705 ;

摘要：

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 (LAC1USC) 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.

引用

页数：7

共 42 条

[41] Clinical Evaluation of Three Sample-to-Answer Platforms for Detection of SARS-CoV-2 [J].