cobas® SARS-CoV-2 &
Influenza A/B Assay

Rapid answers to manage the unknown
SARS_Influenza_AB
Reduce the risk of a misdiagnosis with an accurate test you can trust

Symptoms of COVID-19 and influenza may look the same. It can be difficult for clinicians to identify based on signs and symptoms alone and if left undiagnosed, may result in health complications or community spread.

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.

cobas® SARS-CoV-2 & Influenza A/B performance1

sars-cov-2

* SARS-CoV-2 results of the clinical performance evaluation using prospective NPS specimens. For the SARS-CoV-2 target, results from cobas® SARS-CoV-2 & Influenza A/B were compared to results from three highly sensitive FDA-authorized laboratory-based RT-PCR EUA assays (composite comparator method). 

** Influenza A/B results of the clinical performance evaluation using retrospective NPS specimens. For influenza A/B targets, results from cobas® SARS-CoV-2 & Influenza A/B were compared to results from an acceptable molecular comparator for influenza (comparator method).

Intended use

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 rapid multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the simultaneous qualitative detection and differentiation of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A, and influenza B virus nucleic acid in nasopharyngeal swab (NPS) and anterior nasal swab (ANS) specimens from individuals with signs and symptoms of respiratory tract infection. Clinical signs and symptoms of respiratory tract infection due to SARS-CoV-2 and influenza can be similar.

cobas® SARS-CoV-2 & Influenza A/B is intended for use as an aid in the differential diagnosis of SARS-CoV-2, influenza A, and/or influenza B infection if used in conjunction with other clinical and epidemiological information, and laboratory findings. SARS-CoV-2, influenza A and influenza B viral nucleic acid are generally detectable in NPS and ANS specimens during the acute phase of infection.

Positive results do not rule out co-infection with other organisms. The agent(s) detected by the cobas SARS-CoV-2 & Influenza A/B may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.

Registration Status

FDA 510(k) cleared, CLIA waived

Package inserts

Access package inserts through your country's Roche Diagnostics Website.

References

  1. cobas® SARS-CoV-2 & Influenza A/B Package Insert, Pleasanton, CA, Roche Molecular Systems Inc.
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