List of Authorized At-Home OTC COVID-19 Diagnostic Tests. A reference for those needing a test now and then to rule out COVID-19 (with or without symptoms), this list offers elemental info on a variety of FDA authorized self-tests. Click here to learn more about at-home OTC COVID-19 diagnostic tests and which ones are right for you.
Testing Accuracy and Omicron. The Food and Drug Administration has cautioned against the use of two COVID-19 molecular lab tests (Applied DNA Sciences Linea COVID-19 Assay Kit, and Meridian Biosciences Revogene SARS-CoV-2 RT-PCR Test) to date as the Omicron becomes the dominant variant in the U.S. The concern is that the test will no longer be able to identify the new virus variant's mutation. There are a number of tests that will not be impacted by the mutation. Tide Laboratories has resolved the issue for their DTPM COVID-19 RT-PCR test. Providers are encouraged to seek out tests that use multiple genetic targets to identify SARS-CoV-2 as the virus continues to evolve. To read "SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests", click here. (Updated 1/6/2021)
COVID-19 & Lab Testing Requirements Toolkit. The ADA offers a step-by-step guide of the application process for federal certification to offer COVID-19 rapid response testing for your patients. The toolkit can be accessed here. (Updated July 21, 2021)
- The Clinical Laboratory Improvements Amendments (CLIA)
- State laboratory testing regulations
- How to apply for a Federal Certificate of Waiver
- Test reporting requirements
Guidance for SARS-CoV-2 Point-of-Care and Rapid Testing. This site outlines regulatory requirements for point-of-care and rapid testing, reporting requirements for point-of-care and rapid testing, and specimen collection and handling of point-of-care and rapid tests for those setting up testing in their practice. Visit the website here and find point-of care testing training videos, tips and more. (Updated December 13, 2021)
COVID-19 Testing Overview from the Centers for Disease Control and Prevention (CDC). The COVID-19 Testing Overview webpage from the CDC provides guidance on the types of tests currently available for use to screen for and identify cases of COVID-19, who should be tested, and when. Click here to view.(Updated December 29, 2021)
Screening for COVID19: Deciding Which Test to Use When Establishing Testing Programs. This two-page factsheet from the U.S. Food and Drug Administration (FDA) contains important information for clinicians deciding which kind of test will be best, whether using the test as a screening tool or offering diagnostic testing services, including point-of-care rapid testing. However you go about testing, it is key to know the best use of the test you are handling. To find out which type of test works best for you, click here. (March 19, 2021)
CMS SARS-CoV-2 Laboratory Testing Comparison. A guidance document from Centers for Medicare & Medicaid Services (CMS) is available to provide further clarification on types of SARS-CoV-2 tests and describes the CLIA certification needed to proceed with each type. Dental practices curious about setting up testing at their facility can look to this document to find out more about what their requirements are for administering tests. Click here to read more. (March 19, 2021)