Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay

Daniel Goldenberger; Karoline Leuzinger; Kirstine K Sogaard; Rainer Gosert; Tim Roloff; Klaudia Naegele; Aline Cuénod; Alfredo Mari; Helena Seth-Smith; Katharina Rentsch; Vladimira Hinić; Hans H Hirsch; Adrian Egli

doi:10.1016/j.jviromet.2020.113925

Brief validation of the novel GeneXpert Xpress SARS-CoV-2 PCR assay

J Virol Methods. 2020 Oct:284:113925. doi: 10.1016/j.jviromet.2020.113925. Epub 2020 Jul 10.

Affiliations

¹ Clinical Bacteriology and Mycology, Laboratory Medicine, University Hospital Basel and University of Basel, Basel, Switzerland.
² Clinical Virology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland.
³ Clinical Bacteriology and Mycology, Laboratory Medicine, University Hospital Basel and University of Basel, Basel, Switzerland; Applied Microbiology Research, Laboratory Medicine, Department Biomedicine, University of Basel, Basel, Switzerland.
⁴ Applied Microbiology Research, Laboratory Medicine, Department Biomedicine, University of Basel, Basel, Switzerland.
⁵ Laboratory Medicine, University Hospital Basel, Basel, Switzerland.
⁶ Clinical Virology, Laboratory Medicine, University Hospital Basel, Basel, Switzerland; Infectious Diseases & Hospital Epidemiology, University Hospital Basel, Basel, Switzerland; Transplantation & Clinical Virology, Department Biomedicine, University of Basel, Basel, Switzerland.
⁷ Clinical Bacteriology and Mycology, Laboratory Medicine, University Hospital Basel and University of Basel, Basel, Switzerland; Applied Microbiology Research, Laboratory Medicine, Department Biomedicine, University of Basel, Basel, Switzerland. Electronic address: [email protected].

Abstract

The clinical and epidemiologic management of the SARS-CoV-2 pandemic is critically dependent on molecular assays with short turn-around time. We validated the novel Xpert Xpress SARS-CoV-2 assay using a commercial nucleic acid testing (Roche Cobas 6800). We found an excellent concordance over a range of SARS-CoV-2 loads and across established human coronaviruses.

Keywords: COBAS 6800; COVID-19; Diagnostics; GeneXpert; NAT; PCR; Respiratory infection; SARS-CoV-2; Viruses.

MeSH terms

Betacoronavirus / genetics
Betacoronavirus / isolation & purification*
COVID-19
COVID-19 Testing
Clinical Laboratory Techniques / instrumentation
Clinical Laboratory Techniques / methods*
Clinical Laboratory Techniques / standards
Coronavirus Infections / diagnosis
Coronavirus Infections / virology*
Diagnostic Tests, Routine
Humans
Nasopharynx / virology
Pandemics
Pneumonia, Viral / diagnosis
Pneumonia, Viral / virology*
Polymerase Chain Reaction / instrumentation
Polymerase Chain Reaction / methods
Reproducibility of Results
SARS-CoV-2
Sensitivity and Specificity