Rapid answers to manage the unknown
Symptoms of COVID-19 and influenza may look the same. It can be difficult for clinicians to identify based on signs & symptoms alone and if left undiagnosed, may result in health complications or community spread.
With more than 400,000 deaths1 from COVID-19 reported so far and half a million deaths on average from influenza every year, effective tools are needed to deliver rapid results to manage patient care early and effectively in emergency care settings.
The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System is a multiplex real-time polymerase chain reaction (PCR) test that detects and differentiates SARS-CoV-2, influenza A and influenza B in 20 minutes from a single nasal sample and in just one test.
Relying on the rapid and accurate cobas® SARS-CoV-2 & Influenza A/B performance, healthcare providers on the front line now have the urgent answers they need to confidently triage patients.
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.
FDA-Emergency Use Authorization, CE-IVD
Access package inserts through your country's Roche Diagnostics Website.