Muestra de sangre
Primer plano de mano con guante, sosteniendo una muestra de sangre en un tubo

While the bulk of the diagnostics efforts for the COVID-19 pandemic have focused initially on identifying patients with the disease, there is now also a growing effort to develop serology testing to identify people who have developed antibodies to the disease. This form of testing is a necessary next step to better understand how the disease has spread, it’s prevalence and to allow for public health agencies to develop strategies to help mitigate the virus’s spread in the coming months.

To that end, the U.S. Food and Drug Association (FDA) announced in a statement over the weekend from Commissioner Stephen Hahn, M.D., that the agency will be working in collaboration with the National Cancer Institute (NCI), the National Institute of Allergy and infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC) to create an evaluation system of these tests that are currently under development to be housed at the National Institutes of Health (NIH).

“As the country starts to see positive signs that the mitigation efforts, like stay-at-home orders and social distancing, are working in our fight against the COVID-19 pandemic, the question of when we can return to work and resume our normal activities is one of the most critical issues facing our nation,” Hanh noted in his statement. “Antibody tests—also known as serological tests—may have the potential to play a role in this complex calculation.”

According to the FDA, the evaluation of serological tests will begin soon, and will include the four for which it has already granted Emergency Use Authorization (EUA), as well as those currently under development.

While the agency noted the need to provide these validation services for serological tests, it said that is has also provided flexibility in the development and use of these tests given the unprecedented scale of the challenge of addressing the pandemic. Specifically, it cited it’s announcement in mid-March that is part of its broader diagnostic strategy that allows for the use of tests prior to granting and EUA, if the tests meet the following criteria:

  • the tests are validated by the developer to determine that they are accurate and reliable
  • notification of the developer’s validation is provided to FDA
  • the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis.

These exception do not apply to tests that require at-home specimen collection or at home testing “because of the added challenges in assuring test accuracy that these pose.”

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