Diagnostic accuracy of the Cepheid Xpert Xpress and the Abbott ID NOW assay for rapid detection of SARS-CoV-2: A systematic review and meta-analysis

被引:31
作者
Lee, Jonghoo [1 ]
Song, Jae-Uk [2 ]
机构
[1] Jeju Natl Univ, Sch Med, Dept Internal Med, Jeju Natl Univ Hosp, Jeju, South Korea
[2] Sungkyunkwan Univ, Sch Med, Dept Internal Med, Div Pulm & Crit Care Med,Kangbuk Samsung Hosp, Seoul, South Korea
关键词
COVID-19; testing; diagnosis; point-of-care testing; reverse transcription polymerase chain reaction; SARS-CoV-2;
D O I
10.1002/jmv.26994
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
Rapid and accurate diagnosis of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is essential to prevent the spread of the virus. We investigated the diagnostic accuracy of the Xpert Xpress and the ID NOW assays for rapid detection of SARS-CoV-2 using a systemic review and meta-analysis approach. A systematic literature search was performed using PubMed, Embase, and the Cochrane COVID-19 Study Register. The sensitivity and specificity of these tests for detecting viruses in patients with suspected SARS-CoV-2 infection were pooled. We used commercial and laboratory-developed reverse transcription-polymerase chain reactions as reference standards. The Quality Assessment of Diagnostic Accuracy Studies-2 tool was used to assess the risk of bias. We identified 11 studies involving 1734 subjects for the Xpert Xpress assay and 10 studies involving 1778 subjects for the ID NOW assay. The pooled sensitivity and specificity of the Xpert Xpress assay for detection of SARS-CoV-2 were 0.99 (95% confidence interval [CI], 0.97 to 0.99) and 0.97 (95% CI, 0.95 to 0.98), respectively. The pooled sensitivity and specificity of the ID NOW assay were 0.79 (95% CI, 0.69 to 0.86) and 1.00 (95% CI, 0.98 to 1.00), respectively. The studies included in our analysis seemed to have low methodological quality. The Xpert Xpress assay showed excellent diagnostic accuracy for rapid detection of SARS-CoV-2. However, as the ID NOW assay showed relatively low sensitivity, this test might miss several positive samples.
引用
收藏
页码:4523 / 4531
页数:9
相关论文
共 29 条
[1]   Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR (Publication with Expression of Concern) [J].
Corman, Victor M. ;
Landt, Olfert ;
Kaiser, Marco ;
Molenkamp, Richard ;
Meijer, Adam ;
Chu, Daniel K. W. ;
Bleicker, Tobias ;
Bruenink, Sebastian ;
Schneider, Julia ;
Schmidt, Marie Luisa ;
Mulders, Daphne G. J. C. ;
Haagmans, Bart L. ;
van der Veer, Bas ;
van den Brink, Sharon ;
Wijsman, Lisa ;
Goderski, Gabriel ;
Romette, Jean-Louis ;
Ellis, Joanna ;
Zambon, Maria ;
Peiris, Malik ;
Goossens, Herman ;
Reusken, Chantal ;
Koopmans, Marion P. G. ;
Drosten, Christian .
EUROSURVEILLANCE, 2020, 25 (03) :23-30
[2]   Clinical Evaluation and Utilization of Multiple Molecular In Vitro Diagnostic Assays for the Detection of SARS-CoV-2 [J].
Cradic, Kendall ;
Lockhart, Marie ;
Ozbolt, Patrick ;
Fatica, Lisa ;
Landon, Lorie ;
Lieber, Michael ;
Yang, David ;
Swickard, Juanita ;
Wongchaowart, Nicholas ;
Fuhrman, Susan ;
Antonara, Stella .
AMERICAN JOURNAL OF CLINICAL PATHOLOGY, 2020, 154 (02) :201-207
[3]   Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection (Review) [J].
Dinnes, Jacqueline ;
Deeks, Jonathan J. ;
Adriano, Ada ;
Berhane, Sarah ;
Davenport, Clare ;
Dittrich, Sabine ;
Emperador, Devy ;
Takwoingi, Yemisi ;
Cunningham, Jane ;
Beese, Sophie ;
Dretzke, Janine ;
di Ruffano, Lavinia Ferrante ;
Harris, Isobel M. ;
Price, Malcolm J. ;
Taylor-Phillips, Sian ;
Hooft, Lotty ;
Leeflang, Mariska M. G. ;
Spijker, Rene ;
Van den Bruel, Ann .
COCHRANE DATABASE OF SYSTEMATIC REVIEWS, 2020, (08)
[4]   Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay [J].
Goldenberger, Daniel ;
Leuzinger, Karoline ;
Sogaard, Kirstine K. ;
Gosert, Rainer ;
Roloff, Tim ;
Naegele, Klaudia ;
Cuenod, Aline ;
Mari, Alfredo ;
Seth-Smith, Helena ;
Rentsch, Katharina ;
Hinic, Vladimira ;
Hirsch, Hans H. ;
Egli, Adrian .
JOURNAL OF VIROLOGICAL METHODS, 2020, 284
[5]   Comparison of Abbott ID Now and Abbott m2000 Methods for the Detection of SARS-CoV-2 from Nasopharyngeal and Nasal Swabs from Symptomatic Patients [J].
Harrington, Amanda ;
Cox, Brian ;
Snowdon, Jennifer ;
Bakst, Jonathan ;
Ley, Erin ;
Grajales, Patricia ;
Maggiore, Jack ;
Kahn, Stephen .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)
[6]   Comparison of the Accula SARS-CoV-2 Test with a Laboratory-Developed Assay for Detection of SARS-CoV-2 RNA in Clinical Nasopharyngeal Specimens [J].
Hogan, Catherine A. ;
Garamani, Natasha ;
Lee, Andrew S. ;
Tung, Jack K. ;
Sahoo, Malaya K. ;
Huang, ChunHong ;
Stevens, Bryan ;
Zehnder, James ;
Pinsky, Benjamin A. .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)
[7]   Five-minute point-of-care testing for SARS-CoV-2: Not there yet [J].
Hogan, Catherine A. ;
Sahoo, Malaya K. ;
Huang, ChunHong ;
Garamani, Natasha ;
Stevens, Bryan ;
Zehnder, James ;
Pinsky, Benjamin A. .
JOURNAL OF CLINICAL VIROLOGY, 2020, 128
[8]   Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Assay for the Detection of SARS-CoV-2 in Oropharyngeal Swab Specimens [J].
Hou, Hongyan ;
Chen, Jun ;
Wang, Yueqin ;
Lu, Yanjun ;
Zhu, Yaowu ;
Zhang, Bo ;
Wang, Feng ;
Mao, Lie ;
Tang, Yi-Wei ;
Hu, Bicheng ;
Ren, Yi ;
Sun, Ziyong .
JOURNAL OF CLINICAL MICROBIOLOGY, 2020, 58 (08)
[9]   Systematic reviews and meta-analyses of diagnostic test accuracy [J].
Leeflang, M. M. G. .
CLINICAL MICROBIOLOGY AND INFECTION, 2014, 20 (02) :105-113
[10]   Comparative study of four SARS-CoV-2 Nucleic Acid Amplification Test (NAAT) platforms demonstrates that ID NOW performance is impaired substantially by patient and specimen type [J].
Lephart, Paul R. ;
Bachman, Michael A. ;
LeBar, William ;
McClellan, Scott ;
Barron, Karen ;
Schroeder, Lee ;
Newton, Duane W. .
DIAGNOSTIC MICROBIOLOGY AND INFECTIOUS DISEASE, 2021, 99 (01)