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 worker-collected nasopharyngeal and nasal swabs and self-collected nasal swabs (collected on site with instruction by a healthcare professional) 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 detection and differentiation of SARS-CoV-2, influenza A, and influenza B in clinical specimens and is not intended to detect influenza C. SARS-CoV-2, influenza A and influenza B viral RNA is generally detectable in upper respiratory specimens during 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 infection from SARS-CoV-2, influenza A, and/or influenza B 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.
Negative results obtained from individuals who are not exhibiting clinical signs and symptoms associated with respiratory viral infection at the time of specimen collection should be interpreted with particular caution. Negative results in asymptomatic individuals cannot be used as definitive evidence that an individual has not been exposed to SARS-CoV-2 or influenza viruses and has not been infected with any of these viruses.
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 at the point of care (POC) or in a clinical laboratory setting.