2019 Novel Coronavirus (COVID-19), NAA
Also known as: 2019 Novel Coronavirus, COVID-19, SARS-CoV-2
Use
Detection of SARS-CoV-2 to assist in the diagnosis of COVID-2019 infections.
Special Instructions
Not provided.
Limitations
This test is only authorized under an Emergency Use Authorization (EUA) by the FDA. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. False negatives can occur, particularly if the test is not performed during the acute phase of infection. The test's performance may vary with the mutation rate of the virus, although currently no impact has been observed.
Methodology
PCR-based (RT-PCR)
Biomarkers
SARS-CoV-2
Microorganism
LOINC Codes
- 94500-6 - SARS-CoV-2 RNA Resp Ql NAA+probe
- 94500-6 - SARS-CoV-2 RNA Resp Ql NAA+probe
Result Turnaround Time
1-3 days
Related Documents
For more information, please review the documents below
Specimen
Oropharyngeal Swab
Volume
1.4 mL
Minimum Volume
1 mL
Container
Swab in viral transport medium or ESwab™
Causes for Rejection
Vacutainers, cotton-tip swabs in UTM/VTM, swabs with calcium alginate, swabs with wood shafts, specimens in glass tubes/containers, dry swabs without media, swabs in molecular media, Aptima swabs, swabs in gel-based, anaerobic, or charcoal media, 3D printed swabs, or specimens without swabs.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 24 hours |
| Refrigerated | 72 hours |
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