FDA has authorized an amendment for many molecular diagnostic SARS-CoV-2 tests authorized for diagnosis or screening, which allows emergency use of such tests on pooled specimens for testing individuals without symptoms or other reasons to suspect covid-19, when tested at least once per week as part of a serial testing program without prospective FDA review. The amendment applies only to pooling of anterior nasal respiratory specimens.
To utilize this approach, EUA holders must submit a notification to FDA with specific required information, including validation data (if requesting to pool more than three specimens) and pooling procedures. After this notification is given, the test will be identified on the FDA website and updated labeling will be posted with the test’s EUA on the FDA website.
The public, including organizations purchasing tests to use for testing pooled specimens in serial testing programs, will be able to see the full list of tests authorized for any additional indication under this amendment on the FDA website as well as search the main EUA list on the FDA website to quickly find tests authorized for “pooled serial screening” which will be added as an attribute for each test amended by this authorization.
Last month, the FDA issued a new supplemental template for test developers seeking emergency use authorization of certain tests for screening with serial testing. This Pooling and Serial Testing Amendment builds upon that earlier action.
All serial testing programs should include retesting individuals as needed.
For more information, visit FDA.