The FDA has posted two templates with recommendations on what to include in emergency use authorization (EUA) requests or pre-EUA submissions for serology tests:
- Template for Test Developers of Serology Tests that Detect or Correlate to Neutralizing Antibodies (New)
- Serology Template for Test Developers (Update)
- The FDA updated the template to add clarity throughout and provide recommendations regarding monitoring for and assessing the impact of new SARS-CoV-2 mutations and variants.
These templates provide the FDA’s current recommendations concerning what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for SARS-CoV-2 antibody tests.
The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
The templated can be downloaded from the FDA.