FDA Posts Serology Templates for Test Developers

November 24, 2020

The FDA on Nov. 24 posted two templates with recommendations on what to include in EUA requests for serology tests. 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 templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.

Serology Template for Test Developers 

• This template replaces the individual templates for Commercial Manufacturers and Laboratories. In addition, this template includes recommendations on presenting 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 includes recommendations for submissions for prescription use only home collection devices that are intended for use by an individual to self-collect fingerstick dried blood spot specimen(s) that are then sent to a clinical laboratory for testing with a SARS-CoV-2 antibody test that is authorized for use with the home collection device.