Features

• cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is for use under FDA Emerrgency Use Authorization only: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
• The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is an automated rapid multiplex real-time reverse transcription 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 virus, influenza B virus and respiratory syncytial virus (RSV) RNA in anterior nasal (nasal) swab and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19 by their healthcare provide
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests
• The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is 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
• Positive results are indicative of the presence of SARS-CoV-2, influenza A, influenza B and/or RSV RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Positive results do not rule out bacterial infection or co-infection with other pathogens not detected by the test
• Negative results do not preclude SARS-CoV-2, influenza A, influenza B and/or RSV infection and should not be used as the sole basis for patient management decisions
• Negative results must be combined with clinical observations, patient history, and/or epidemiological information
• The cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is intended for use by trained operators specifically instructed in the use of the cobas® liat system and the cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test

Product Specifications