Pooled testing has been widely proposed as a way to expand capacity for large-scale screening (1,2; C.M. Verdun, unpub data, https:// doi.org/10.1101/2020.04.30.20085290), a proactive strategy for early pathogen detection, primarily for persons who are not yet symptomatic.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.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.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.