The FDA is making it easier for the makers of authorized COVID-19 tests to have multiple samples tested at once—allowing more people to be screened more regularly while using fewer resources.
This pooled testing approach has been previously green-lit by the agency for individual companies since last summer; the strategy only checks single samples when the larger batch returns a positive result.
Now, the FDA will begin issuing amendments to a potentially broad number of its past authorizations for certain molecular diagnostics—including those for people who are showing no symptoms, and only require a simple swab of the front of the nose, compared to the deeper nasopharyngeal swabs common during the early phases of the pandemic.
“If a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program,” the FDA’s device center director, Jeffrey Shuren, said in a statement, describing the move as a way to assist schools, workplaces and others establish routine testing programs.
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Test developers must provide the FDA with their validation data and procedures to be able to pool more than three specimens at once.
Up to three samples can be placed in the same transport vial—including self-performed swabs and those collected by a healthcare professional—without additional validation, as long as the analysis is performed in certified CLIA labs.
This will allow for tests to be used to screen people at least once per week without first going through agency review. A list of pooled tests will be maintained on the FDA’s website.
In addition, the FDA said that routine testing does not replace the need for other public health measures such as getting vaccinated, social distancing, washing hands and wearing masks.