COVID-19 Molecular Test
SARS-CoV-2 Virus (nucleic acid) Testing
20/20 offers COVID-19 testing using RT-PCR to detect SARS-CoV-2 virus infection using nasopharyngeal swabs. The COVID-19 test provides sensitive and reliable results for detecting the two major viral genes to the SARS-CoV-2 virus that are recommended by the US Centers for Disease Control (CDC). (N1 gene, N2 gene).
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of presence of SARS-CoV-2 RNA. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status.
KEY FEATURES & BENEFITS
- Good for organizations that want to coordinate their own testing
- Fast turnaround of results < 3 days
- Authorized by FDA for emergency use only (EUA )
General Precautions
1. For Emergency Use Authorization (EUA) only.
2. For Prescription Use Only.
3. For in vitro diagnostic use.
4. The SARS-CoV-2 Assay has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
5. The SARS-CoV-2 Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
6. The SARS-CoV-2 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests 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.
7. Results should be interpreted in combination with the patient’s signs and symptoms and results from other diagnostic tests by a trained healthcare professional.
ORDERING
To order, you may place an online order for test collection kits or call our sales department at (240) 453-6339.
Please feel free to use the form below to contact us.
Resources
Healthcare provider fact sheet
Patient Fact Sheet
FDA Emergency Use Authorization (EUA)