The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2 & influenza A, and influenza B virus RNA in healthcare provider-collected nasopharyngeal and nasal swabs, and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.
cobas® SARS-CoV-2 & Influenza A/B is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2 & influenza A virus, and influenza B virus nucleic acids in clinical specimens and is not intended to detect influenza C virus. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2 & influenza A, and/or influenza B 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 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat® System.
In the United States (US), testing with cobas® SARS-CoV-2 & Influenza A/B is authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests. cobas® SARS-CoV-2 & Influenza A/B is also 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. Testing facilities within the U.S. and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities. In the U.S., cobas® SARS-CoV-2 & Influenza A/B is only for use under the Food and Drug Administration’s Emergency Use Authorization.
In the United States:
• This test has not been FDA cleared or approved;
• This test has been authorized by FDA under an EUA for use by authorized laboratories;
• This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2 & influenza A virus and influenza B virus; not for any other viruses or pathogens; and
• This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner