cobas® SARS-CoV-2 is for use under the Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
cobas® SARS-CoV-2 is authorized for use at the Point of Care (POC)
i.e.
in patient care settings operating under a CLIA Certificate of Waiver
Certificate of Compliance
or Certificate of Accreditation
In the United States (US)
testing with cobas® SARS-CoV-2 is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
42 U.S.C. §263a
that meet requirements to perform moderate or high complexity tests
Positive results are indicative of the presence of SARS-CoV-2 RNA
Positive results do not rule out bacterial infection or co-infection with other viruses; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis
treatment or other patient management decisions
Negative results must be combined with clinical observations
patient history
and/or epidemiological information
cobas® SARS-CoV-2 is intended for use by health professionals or trained operators who are proficient in using the cobas Liat System
Laboratories within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
Kit includes: 8 Transfer Pipettes
1 control kit barcode card
3 X 0.25 mL Positive Control
3 X 0.3 mL Dilution UTM
Requires: cobas® Liat® Analyzer (P/N 07341920190) including cobas® Liat® System Software (Core) Version 3.3 or higher and cobas® SARS CoV-2 Assay Script v1.0 or higher
