SARS‑CoV‑2 RNA (COVID‑19) and Influenza A and B, Qualitative NAAT
Also known as: Novel Coronavirus, Wuhan, COVID19, Flu, nCOV
Use
This molecular nucleic acid amplification test (NAAT) qualitatively detects and differentiates the presence of SARS‑CoV‑2 (COVID‑19), Influenza A, and Influenza B in respiratory specimens, enabling rapid and accurate identification of the causative viral pathogen to inform patient diagnosis and management.
Special Instructions
Authorized under FDA Emergency Use Authorization (EUA) for unsupervised self‑collection of nasal specimens in applicable jurisdictions; ordering requires a provider test order with appropriate ICD‑10 codes; supervised self‑collection may be available at select patient service centers depending on state regulations (unavailable in AL, AZ, DE, HI, KY, LA, ME, MN, MS, MT, ND, OK, RI, UT, VT, WA, WY).
Limitations
This test is authorized under EUA only and not FDA cleared or approved; limited to detection of SARS‑CoV‑2, Influenza A, and Influenza B—not other pathogens. Negative results do not rule out infection, and positive results require clinical correlation. Self‑collection availability and specimen handling limitations vary by state. Use is limited to the duration of the public health emergency declaration.
Methodology
PCR-based (PCR)
Biomarkers
Result Turnaround Time
2-3 days
Related Documents
For more information, please review the documents below
Specimen
Nasopharyngeal Swab
Volume
Not provided
Minimum Volume
Not provided
Collection Instructions
Unsupervised self‑collection of nasal specimens authorized; supervised self‑collection at PSC may be available depending on state regulations.