The Food and Drug Administration (FDA) has announced an expansion for the Emergency Use Authorization (EUA) for LabCorp's PCR test that detects SARS-CoV-2's genetic material. Following the release of data that the test's accuracy was applicable to the general population, the EUA now allows its use for asymptomatic persons as well as for pooled samples. The FDA has been moving towards such allowances since last month, when it expanded its developer templates to include tests conducted under these circumstances.
In a recent update to its testing guidance page, the Centers for Disease Control and Prevention defined pooled testing as a two-part testing strategy. Initially a batch of samples are run together and, if a result is negative, the entire group is deemed negative. A positive result, however, necessitates that each sample be then tested individually. The major benefit behind such a process is the saving of resources when a pooled sample returns positive. Various.