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Determining Acceptable COVID-19 Tests for Unvaccinated School Personnel, Higher Ed Personnel, and Higher Ed Students

Sep 1, 2021

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As a follow-up to our complimentary webinars on August 31, 2021, and in response to questions regarding the testing requirements, we have compiled a summary of the Food and Drug Administration’s authorized tests. Note that per the Governor’s Executive Order issued August 26, 2021, “[COVID-19] testing must be done using a test that either has Emergency Use Authorization by the FDA or be operating per the Laboratory Developed Test requirements by the U.S. Centers for Medicare and Medicaid Services.” (See the full order here). School districts and higher education institutions should consult with their local health department for any additional restrictions or limitations on the use of tests to comply with the Executive Order.

There are two different types of COVID-19 tests: diagnostic tests and antibody tests. Diagnostic tests are those which can indicate if an individual has an active COVID-19 infection. Diagnostic tests come in two forms: molecular tests and antigen tests. Well-known examples of these tests are the RT-PCR test (diagnostic) and Rapid Tests (antigen) and would include Shield and BinaxNOW.  In contrast, antibody tests should not be used to diagnose an active COVID-19 infection, as these types of tests simply identify the presence of antibodies in an individual’s immune system and suggest a prior infection.

As of August 27, 2021, there are several hundred tests and sample collection devices which have been approved under emergency use authorization (“EUA”) by the FDA. Of these, the FDA has specifically authorized 14 antigen tests and 8 molecular tests for “serial screening” programs. Serial screening refers to the testing of asymptomatic individuals multiple times on a routine basis.

This link can be used to directly access the authorized molecular tests, and the authorized antigen tests can be found here. Both links also contain a search bar for quick searches.

Again, the local health department should provide further clarity on acceptable tests for personnel and students subject to the Executive Order.

Please contact your Robbins Schwartz Attorney with any questions.