Coronavirus Diagnostic Tests
- There are a large number of gray market tests being marketed, not all with reliable results.
I want to test my patients for COVID-19 when they come to my dental office. What do I need to do that?
You must register as a dentist-owned laboratory with the New York State Department of Health POLEP (Physician Owned Laboratory Evaluation Program) – but currently there are no POLEP -authorized COVID-19 tests. POLEP registration allows both dentists and physicians to conduct CLIA-waived laboratory tests in their offices on their own patients where such tests are deemed necessary or useful to providing services to patients. CLIA-waived tests are those tests that the United States Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) consider simple and reliable enough not to need referral out to a CLIA laboratory. CLIA is short for the federal law called the “Clinical Laboratory Improvement Amendments." For dentists, these CLIA-waived tests are not for diagnostic purposes, but are screening tools for making appropriate referrals for medical care by physicians where appropriate prior to dental treatment. Currently, while there are some COVID-19 in-office tests that are deemed to be CLIA-waived through Emergency Use Authorizations (EUAs) granted by the FDA, none of them are on the current POLEP test authorization list in New York yet. This can change daily, so dentists need to check with POLEP daily for updated authorized test lists. To register with POLEP, go to: https://www.wadsworth.org/regulatory/polep.
FAQs on Diagnostic Testing for SARS-CoV-2
See NYSDOH for testing information