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Frequently Asked Questions

What is pooled sample testing FDA?

Pooled Sample Testing The FDA is aware that there is a great interest in performing testing using pooled samples. Pooling samples involves mixing several samples together in a "batch" or pooled sample, then testing the pooled sample with a diagnostic test.

What is the FDA standard for test performance after pooling?

Therefore, the FDA generally recommends that, after pooling, test performance includes ≥85% percent positive agreement (PPA) when compared with the same test performed on individual samples.

Does the CLIA-certified laboratory report results of a pooled test?

The CLIA-certified laboratory should not report positive or indeterminate results of a pooled test to either the individuals in the pool, or the local, state, tribal, or territory health department.

Why are the samples being pooled?

Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to receive their results more quickly in most cases.

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