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Frequently Asked Questions

What is pooled testing?

In response, pooled testing has emerged as a promising strategy that can immediately increase testing capacity. In pooled sample testing, multiple samples are combined (or pooled) together and tested as a single unit. If the pool is positive, the individual samples can then be individually tested to identify the positive case(s).

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

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

Does the Cepheid Xpert CT/ng assay work for extragenital Chlamydia detection?

Meta-analysis of the Cepheid Xpert ® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens.

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.

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