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FFCRA - FAQs 51 and at home antibody tests


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We read the new FAQs 51 as requiring that plans cover at home antigen AND antibody tests, provided they meet the statutory criteria of FFCRA 6001(a)(1) (e.g. approved by FDA or have an EUA).  This is based on FAQ 42, Q4 which includes serological tests, i.e. antibody tests, in the definition of in vitro diagnostic tests.  Commentary thus far focuses on the antigen test (i.e. to detect the virus) and not antibody, so just looking to see if others interpretting these FAQs to also cover at home antibody tests.  Thanks.

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I would say both antigen and antibody tests are covered per footnote 10 in FAQ Set 51.

 

FAQ Set 51 - PDF page 3

…since June 2020, when FAQs Part 43 were issued, the FDA has authorized additional diagnostic tests for COVID-19, including tests that can be self-administered and self-read at home or elsewhere without the involvement of a health care provider, sometimes referred to as self-tests or at-home tests.10

10 The FDA provides information on which at-home tests are authorized for use at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas

 

At that webpage, the introduction lists both types of tests .

 

There are several types of SARS-CoV-2 and COVID-19 related IVDs:

  • Diagnostic Tests: Tests that detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests.
  • Serology/Antibody and Other Adaptive Immune Response Tests: Tests that detect antibodies (for example, IgM, IgG) to the SARS-CoV-2 virus or that measure a different adaptive immune response (such as, T cell immune response) to the SARS-CoV-2 virus. These types of tests cannot be used to diagnose a current infection.
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