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MIDL PCR SARS CoV-2 and Influenza A/B ()

Department: Molecular Infectious Disease
Test Synonym(s): LAB6330, PCR SARS-CoV-2/Influenza A and B, PCR SARS-CoV-2/Flu, PCR COVID-19/Flu
Test Components: Roche Cobas 6800 SARS-CoV-2 & Influenza A/B
CPT Codes: 87631
Methodology: Multiplex PCR
Reference Range: Not detected
Tube Type: Viral Transport Media
Specimen: Nasopharyngeal Swab, Nares Swab
Alternate Specimen: Alternate specimen types will be sent to a reference lab for testing.
Volume: 3 mL
Minimum Volume: 0.5 mL
Temperature: Room temperature (15-25 C): up to 24 hours; Refrigerated (2-8 C): up to 3 days; Frozen (-15C or -70C): p to 30 days
Stability: Room temperature: 24 hours
Reasons for Rejection: Alternative specimen sent without Medical Director approval
Days Performed: Daily
Times Performed: Daily
TAT: 24 hours
Significance: cobas® SARS-CoV-2 & Influenza A/B assay for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus RNA in healthcare provider-collected nasal and nasopharyngeal swab specimens, and self-collected nasal swab specimens (collected in a healthcare setting with instruction by a healthcare provider) from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. 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 influenza B in humans and is not intended to detect influenza C.


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