Tags

Type your tag names separated by a space and hit enter

Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test.
J Clin Microbiol. 2020 Jul 23; 58(8)JC

Abstract

Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs). Clinical performance was assessed using 483 remnant upper- and lower-respiratory-tract specimens previously analyzed by standard-of-care (SOC) NAATs. The limit of detection of the Xpert test was 0.01 PFU/ml. Other hCoVs, including Middle East respiratory syndrome coronavirus, were not detected by the Xpert test. SARS-CoV, a closely related species in the subgenus Sarbecovirus, was detected by a broad-range target (E) but was distinguished from SARS-CoV-2 (SARS-CoV-2-specific N2 target). Compared to SOC NAATs, the positive agreement of the Xpert test was 219/220 (99.5%), and the negative agreement was 250/261 (95.8%). A third tie-breaker NAAT resolved all but three of the discordant results in favor the Xpert test. The Xpert test provided sensitive and accurate detection of SARS-CoV-2 in a variety of upper- and lower-respiratory-tract specimens. The high sensitivity and short time to results of approximately 45 min may impact patient management.

Authors+Show Affiliations

Cepheid, Sunnyvale, California, USA Michael.loeffelholz@cepheid.com.Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.Keck School of Medicine of USC, Department of Pathology, Los Angeles, California, USA.Children's Hospital Los Angeles, Los Angeles, California, USA.Niguarda Hospital, Ospedale Niguarda Ca' Granda, Milan, Italy.Niguarda Hospital, Ospedale Niguarda Ca' Granda, Milan, Italy.The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.Department of Virology, Manchester University NHS Foundation Trust, Manchester, United Kingdom.NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA.NYC Public Health Laboratory, Department of Health and Mental Hygiene, New York, New York, USA.Bacteriology-Virology, Henri Mondor Hospital, Creteil, France.Bacteriology-Virology, Henri Mondor Hospital, Creteil, France.Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.Center for Emerging Pathogens, Department of Medicine, Rutgers-New Jersey Medical School, Newark New Jersey, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.Cepheid, Sunnyvale, California, USA.

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

32366669

Citation

Loeffelholz, Michael J., et al. "Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test." Journal of Clinical Microbiology, vol. 58, no. 8, 2020.
Loeffelholz MJ, Alland D, Butler-Wu SM, et al. Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. J Clin Microbiol. 2020;58(8).
Loeffelholz, M. J., Alland, D., Butler-Wu, S. M., Pandey, U., Perno, C. F., Nava, A., Carroll, K. C., Mostafa, H., Davies, E., McEwan, A., Rakeman, J. L., Fowler, R. C., Pawlotsky, J. M., Fourati, S., Banik, S., Banada, P. P., Swaminathan, S., Chakravorty, S., Kwiatkowski, R. W., ... Persing, D. H. (2020). Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. Journal of Clinical Microbiology, 58(8). https://doi.org/10.1128/JCM.00926-20
Loeffelholz MJ, et al. Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. J Clin Microbiol. 2020 Jul 23;58(8) PubMed PMID: 32366669.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter Evaluation of the Cepheid Xpert Xpress SARS-CoV-2 Test. AU - Loeffelholz,Michael J, AU - Alland,David, AU - Butler-Wu,Susan M, AU - Pandey,Utsav, AU - Perno,Carlo Frederico, AU - Nava,Alice, AU - Carroll,Karen C, AU - Mostafa,Heba, AU - Davies,Emma, AU - McEwan,Ashley, AU - Rakeman,Jennifer L, AU - Fowler,Randal C, AU - Pawlotsky,Jean-Michel, AU - Fourati,Slim, AU - Banik,Sukalyani, AU - Banada,Padmapriya P, AU - Swaminathan,Shobha, AU - Chakravorty,Soumitesh, AU - Kwiatkowski,Robert W, AU - Chu,Victor C, AU - Kop,JoAnn, AU - Gaur,Rajiv, AU - Sin,Mandy L Y, AU - Nguyen,Duy, AU - Singh,Simranjit, AU - Zhang,Na, AU - Persing,David H, Y1 - 2020/07/23/ PY - 2020/04/29/received PY - 2020/04/30/accepted PY - 2020/5/6/pubmed PY - 2020/8/6/medline PY - 2020/5/6/entrez KW - COVID-19 KW - RT-PCR KW - SARS-CoV-2 KW - Xpert JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 8 N2 - Nucleic acid amplification tests (NAATs) are the primary means of identifying acute infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Accurate and fast test results may permit more efficient use of protective and isolation resources and allow rapid therapeutic interventions. We evaluated the analytical and clinical performance characteristics of the Xpert Xpress SARS-CoV-2 (Xpert) test, a rapid, automated molecular test for SARS-CoV-2. Analytical sensitivity and specificity/interference were assessed with infectious SARS-CoV-2; other infectious coronavirus species, including SARS-CoV; and 85 nasopharyngeal swab specimens positive for other respiratory viruses, including endemic human coronaviruses (hCoVs). Clinical performance was assessed using 483 remnant upper- and lower-respiratory-tract specimens previously analyzed by standard-of-care (SOC) NAATs. The limit of detection of the Xpert test was 0.01 PFU/ml. Other hCoVs, including Middle East respiratory syndrome coronavirus, were not detected by the Xpert test. SARS-CoV, a closely related species in the subgenus Sarbecovirus, was detected by a broad-range target (E) but was distinguished from SARS-CoV-2 (SARS-CoV-2-specific N2 target). Compared to SOC NAATs, the positive agreement of the Xpert test was 219/220 (99.5%), and the negative agreement was 250/261 (95.8%). A third tie-breaker NAAT resolved all but three of the discordant results in favor the Xpert test. The Xpert test provided sensitive and accurate detection of SARS-CoV-2 in a variety of upper- and lower-respiratory-tract specimens. The high sensitivity and short time to results of approximately 45 min may impact patient management. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32366669/full_citation L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32366669 DB - PRIME DP - Unbound Medicine ER -