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Frequently Asked Questions

What is pooled testing and how does it work?

The major bottleneck in leveraging testing capacity has been the lack of diagnostic resources. Pooled testing is a potential approach that could reduce cost and usage of test kits. This method involves pooling individual samples and testing them ‘en bloc’. Only if the pool tests positive, retesting of individual samples is performed.

What is the FDA's policy on testing using pooled samples?

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. This approach increases the number of individuals that can be tested using the same amount of resources.

What are the limitations of the pooled testing approach?

It is always important to restrict pooled testing approach for prevalence up to 5%. As prevalence increases, the efficiency of the pooled testing flattens.

What should I do if the pooled test result is positive?

If the pooled test result is positive, each of the specimens in the pool will need to be tested individually to determine which specimen (s) is (are) positive. Sufficient volume of the specimen must be available for any subsequent individual retesting.

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