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

Autor: Karen C. Carroll, Rajiv L. Gaur, VC Chu, Robert Kwiatkowski, Carlo Frederico Perno, Susan M. Butler-Wu, Mandy L. Y. Sin, Simranjit Singh, Ashley McEwan, Alice Nava, Jennifer L. Rakeman, Duy Nguyen, Randal C. Fowler, David H. Persing, Shobha Swaminathan, Na Zhang, David Alland, Jean-Michel Pawlotsky, Jo Ann Kop, Sukalyani Banik, Emma Davies, Michael J. Loeffelholz, Slim Fourati, Utsav Pandey, Heba H. Mostafa, Soumitesh Chakravorty, Padmapriya P. Banada
Rok vydání: 2020
Předmět:
0301 basic medicine
Male
viruses
medicine.disease_cause
0302 clinical medicine
COVID-19 Testing
Nasopharynx
030212 general & internal medicine
skin and connective tissue diseases
Child
Coronavirus
Aged
80 and over
biology
Special Issue
Clinical performance
virus diseases
Middle Aged
Patient management
Molecular Diagnostic Techniques
Child
Preschool
Female
Coronavirus Infections
Microbiology (medical)
Adult
Adolescent
Middle East respiratory syndrome coronavirus
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
030106 microbiology
Pneumonia
Viral
RT-PCR
Sensitivity and Specificity
03 medical and health sciences
Betacoronavirus
Young Adult
Virology
medicine
Nucleic Acid Amplification Tests
Humans
Xpert
Pandemics
Aged
Automation
Laboratory
business.industry
Clinical Laboratory Techniques
SARS-CoV-2
fungi
Infant
Newborn
COVID-19
Infant
biology.organism_classification
body regions
business
Zdroj: Journal of Clinical Microbiology
ISSN: 1098-660X
Popis: 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).
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.
Databáze: OpenAIRE
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