cobas® SARS-CoV-2

The cobas® SARS-CoV-2 nucleic acid test for use on the cobas® liat system (cobas®  SARS-CoV-2) is an automated, real-time reverse transcriptase polymerase chain reaction (RT-PCR) test intended for the rapid in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in anterior nasal (nasal) and nasopharyngeal swab specimens collected from individuals with signs and symptoms of respiratory tract infection (i.e.,  symptomatic). Additionally, this test is intended to be used with nasal and nasopharyngeal swab specimens collected from individuals without signs and symptoms suspected of COVID-19 (i.e., asymptomatic).  The cobas® SARS-CoV-2 performed on the cobas® liat  system is intended for use as an aid in the diagnosis of COVID-19 if  used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. Positive results do not rule out co-infection with other microorganisms. A negative result from an asymptomatic individual is presumptive. Additionally, a negative result obtained with a nasal swab collected from an asymptomatic patient should be followed up by testing at least twice over three days with at least 48 hours between tests. Negative results do not preclude SARS-CoV-2 infection. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. This test is intended for prescription use only and can be used in Point-of-Care settings.