Test Details
SARS-CoV-2 PCR (COVID-19)
Uses a nasal, nasopharyngeal or oropharyngeal swab to detect SARS-CoV-2 virus (the virus that causes COVID-19) using a reverse transcriptase polymerase chain reaction (RT-PCR) test that is authorized for use under the FDA's Emergency Use Authorization (EUA)*
EUA200124
Providers Fact Sheet
Patient Fact Sheet
EUA Summary
Methodology
Multiplex RT-PCR Assay
Patient Preparation
None
Preferred Specimen
- nasal swab (order code 896)
Alternate Specimen
- nasopharyngeal swab (order code 895)
- oropharyngeal swab (order code 898)
Transport Temperature
Shipping with frozen cold packs preferred. Room temperature acceptable.
Stability
- Refrigerated: 7 days.
- Room temperature: 7 days.
*This product has not been FDA cleared or approved, but 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.The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Lab Values
SARS-CoV-2 PCR (COVID-19)
- A positive result indicates the detection of the SARS-CoV2 (COVID19) virus.
Clinical Significance
SARS-CoV-2 PCR (COVID-19)
Symptoms often develop an average of 5 days (range 2-14 days) after SARS-CoV-2 infection. Diagnosis of a current infection is made by having a positive RT-PCR swab test usually within 3 days of infection and may become undetectable after 2-4 weeks from disease onset. Detects two regions of the Nucleocapsid gene (N-Gene) of SARS- CoV-2 and produces one target signal.
- This assay currently detects all known variants, but does not distinguish between them.
- Detects SARS-CoV-2 RNA with high sensitivity as low as approximately 67 copies per mL.
Treatment Options
SARS-CoV-2 PCR (COVID-19)
Symptomatic SARS-CoV-2 (COVID-19) infections usually resolve without treatment, and vaccination is recommended for prevention. Severe cases may require hospitalization and/or medical treatment.
