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FDA Releases Two New Serology Templates for Test Developers

FDA maze of regulations

New templates for SARS-CoV-2 antibody testing help guide test developers on data that should be submitted for EUA applications

The US Food and Drug Administration (FDA) announced Nov. 24, 2020, that it has released two new SARS-CoV-2 serology test development templates. The stated purpose of these templates is to guide test developers in providing validation data and to help test developers understand what is necessary to include when submitting an emergency use authorization (EUA) for these tests.

The FDA’s announcement stated, “These templates provide the FDA’s current recommendations on what data and information should be submitted to the FDA in support of an EUA request or pre-EUA submission for a SARS-CoV-2 antibody test or home specimen collection devices using dried blood spot.” The FDA also explained that while these test templates are designed to help test developers to provide data to the FDA, other approaches can be used.

The two templates include:

  • Serology Template for Test Developers: This template replaces the individual serology templates for commercial manufacturers and laboratories. Additionally, the FDA states that this template gives recommendations for providing “clinical agreement data stratified by time from symptom onset and recommendations for tests with semi-quantitative claims.”
  • Home Specimen Collection Serology Template for Fingerstick Dried Blood Spot: This template addresses SARS-CoV-2 antibody tests that used dried blood spots that are self-collected at home then sent to a clinical laboratory.

Clinical laboratory leaders or COVID-19 test developers wanting to view these new templates can do so here.

Related Resources:

FDA: Coronavirus (COVID-19) Update: November 24, 2020

FDA Templates: In Vitro Diagnostics EUAs

COVID-19 STAT: FDA Authorizes First SARS-CoV-2 Antibody Test That Can be Performed at the Point of Care