Symptoms of COVID-19 and influenza may look similar1. Providing access to reliable and efficient testing on the fully-automated cobas® 6800/8800 Systems can help guide treatment decisions and prevent further disease transmission.
Both SARS-CoV-2 and influenza infections can present with similar symptoms, but treatment directions are likely to be different1. Knowing what infection a patient has will allow the clinician to optimally guide triage and treatment decisions, and bring confidence to patients.
The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider.
Provide accurate diagnosis of SARS-CoV-2 or Influenza A/B infection for proper patient management.
Offer reliable and affordable testing to reduce further virus spreading after close contact with infected individuals.
Leverage high-volume cobas® 6800/8800 Systems and broad menu to expand COVID-19 testing solutions.
FDA-Emergency Use Authorization, CE-IVD
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 acids from SARS-CoV-2, influenza A virus, and influenza B virus, and 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 emergency use of in vitro diagnostics 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.