The FDA is allowing what’s called “pooled” testing for COVID-19. On Saturday, July 18, it issued an Emergency Use Authorization to Quest Diagnostics allowing them to combine up to four individual COVID-19 tests together for testing.
If the result is negative, it means that none of the four are positive for COVID-19. If it is positive, it means that one or more of those patients who were tested have COVID-19, and at that point each of the four individuals would be retested, individually.
Pooling saves on testing resources, which is important since there is such an increased demand for testing and supplies are somewhat limited. Kaiser Health News reported on July 9 that getting test results on the mainland is taking a week or longer due to increased demand. Hawaii testing labs are still able to provide results fairly quickly but Diagnostic Labs, one of the state’s two major laboratories, was informed by one of its suppliers that its supply of testing materials is being diverted to the mainland, where demand is greater.
According to the FDA EUA: While there is a concern that combining samples may make it more difficult to detect positives, since pooling in the laboratory dilutes any viral material present in the samples, Quest’s validation data demonstrates that its test correctly identified all of the pooled samples that contained a positive sample. It is important to note that the Quest test, initially authorized on March 17, 2020, remains authorized to test individual samples collected by their health care provider from people with suspected COVID-19 infection.
Dr. Scott Miscovich discussed COVID-19 testing in a discussion with New West Broadcasting’s Sherry Bracken, recorded before the FDA’s new order, and is available here. After the FDA issued the order, Miscovich praised the move.
