The Food and Drug Administration (FDA) posted a new template for at-home and over-the-counter COVID-19 diagnostic tests for use in non-lab settings (press release). The template is intended to be used by commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostics tests that can be performed at home or in other settings besides a lab, such as schools or offices.
The template provides the following recommendations for commercial developers:
- Recommendations for validation when a sample is to be collected, analyzed, and results returned without sending the sample to a lab for analysis; and
- Recommendations for the validation of tests that are intended to be made available over-the-counter, without a prescription.
Additionally, the template provides recommended sensitivity and specificity performance for these types of tests. The FDA notes that while the recommended sensitivity for these tests is lower than lab-based tests, the benefits of broader access to simple and fast testing outweigh the risk.