NMDA Journal Winter 2020-21

nmdental.org 21 Testing for COVID-19 Clinical Laboratory Improvement Amendments (CLIA) of 1988 Now that we have reviewed all the various tests and looked at the possibility of adminis- tering the antigen COVID-19 tests in the office, we must follow CLIA regulations. “CLIA regu- lations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diag- nose, prevent, or treat disease” (cdc.org) . The FDA has organized the various lab tests into three categories, based on the level of complexity to process at test in a lab. It is helpful to know and understand these cate- gories as you start to apply for CLIA certifica- tion. The FDA lists SARS-CoV and SARS-CoV-2 tests in a table format, and each FDA EUA test will have one or all of the letter designa- tions H, M and W. High complexity tests (H) and moderate complexity tests (M) are only for lab-based testing. Point-of-care testing operates under a Certificate of Waiver (W). The American Dental Association has a tool- kit that is available to help guide dentists and dental specialists who are applying for CLIA waiver certification. The toolkit also pro- vides guidance on the type of PPE that should be worn when collecting test samples, how to code for tests on a medical benefit claim, and the reporting requirements. If you have not yet downloaded the toolkit you can access it at www.ada.org . As you navigate through this unprecedented time, remember, you have the ADA and NMDA to lean on for assistance. Resources: https://www.abbott.com/BinaxNOW-Test-NAVICA-App.html#/ https://www.bd.com/en-us/offerings/capabilities/microbiology-solutions/ point-of-care-testing/bd-veritor-plus-system-for-rapid-covid-19-sars-cov- 2-testing www.cdc.org www.fda.org David A.J. Tyrrell and Steven H. Myint. Chapter 60: Coronaviruses. Medical Microbiology. 4th ed. Galveston (TX). University of Texas Medical Branch at Galveston, 1996. John Hopkins Bloomberg School of Public Health, “Molecular-Based Tests for COVID-19.” https://www.centerforhealthsecurity.org/resources/ COVID-19/molecular-based-tests/ Klemaszewski, James. “School of Molecular Sciences researchers lead rapid COVID-19 test development.” Arizona State University. October 2020. Prinzi, Andrea. “How the SARS-CoV-2 EUAAntigen TestsWork.” American Society for Microbiology. https://asm.org/Articles/2020/ August/How-the-SARS-CoV-2-EUA-Antigen-Tests-Work https://publichealth.yale.edu/salivadirect/about/ https://www.quidel.com/immunoassays/fluorescent-immunoassays-fia