cobas^® SARS-CoV-2 Duo Test

cobas^® SARS-CoV-2 Duo for use on the cobas^® 6800/8800 Systems is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas^® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider. 

Results are for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. At this time, correlation of viral load with a specific clinical diagnosis, prognosis or patient management decision has not been clinically established. Patient management should therefore be based on the qualitative result upon consideration of clinical observation, patient history and other diagnostic information. The numerical values for the viral load are for information only. Positive results do not rule out bacterial infection or co-infection with other viruses. 

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. cobas^® SARS-CoV-2 Duo is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas^® 6800/8800 Systems. cobas^® SARS-CoV-2 Duo is only for use under the Food and Drug Administration’s Emergency Use Authorization. 

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 product has been authorized only for the detection of nucleic acid from SARS-CoV-2, 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