User:Shawndouglas/sandbox/sublevel1
As mentioned in the previous chapter, the benefits of antigen testing For COVID-19 and other viral infections are 1. specimen collection can typically be done with a simple nasal swab rather than a more invasive nasopharyngeal swab, 2. testing is more rapid and convenient, and 3. it takes some pressure off the PCR supply chain. However, antigen testing only tests what's there, rather than amplifying the amount, resulting in generally lower sensitivities.[1][2] As such, the real utility of antigen testing, despite its lower sensitivity, appears to be surveillance situations where a large group of individuals who are at risk can be screened at regularly scheduled intervals of two to four days. If your lab is able to support this sort of testing, then this type of testing may be an option. As of September 2021, thirty-four FDA EUAs for antigen tests have been issues; 28 of those 34 include allowances for CLIA-waived testing, and 10 were authorized for home use.[3] Review the FDA list to further examine your options.
The CDC emphasizes that molecular testing remains the "gold standard" for detecting SARS-CoV-2 in a sample, and it "may be necessary to confirm an antigen test result with a laboratory-based NAAT, especially if the result of the antigen test is inconsistent with the clinical context." However, some molecular tests designed for point-of-care testing may not be sufficiently designed for confirmatory testing; consult the instructions for use for any confirmatory test.[4] The CDC makes available two antigen testing algorithms for determining when confirmatory testing is actually recommended.[4]
References
- ↑ Service, R.F. (2020). "Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say". Science. doi:10.1126/science.abe1546.
- ↑ Guglielmi, G. (2020). "The explosion of new coronavirus tests that could help to end the pandemic". Nature 583: 506–09. doi:10.1038/d41586-020-02140-8.
- ↑ "In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2". U.S. Food and Drug Administration. 7 September 2021. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2. Retrieved 07 September 2021.
- ↑ 4.0 4.1 Centers for Disease Control and Prevention (9 September 2021). "Interim Guidance for Antigen Testing for SARS-CoV-2". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html. Retrieved 18 September 2021.
