Emergency Use Authorization Issued for COVID-19 Pooled Testing

July 21, 2020 - FDA recently reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its sample COVID-19 pooled testing tool.

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The Quest SARS-CoV-2 rRt-PCR test is intended for use with pooled samples containing up to four individual swab specimens collected under observations.

Quest’s test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

“This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies,” FDA Commissioner Stephen M. Hahn, MD, said in the announcement. 

“Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population.”

According to FDA, sample pooling allows for more individuals to be tested quickly using fewer testing resources. The samples collected are tested in a “batch” using one test. If the pool is positive, one or more of the individuals in the group may be infected, so each of the samples in that pool are tested again individually. 

Sample pooling generally means that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time, FDA stated. This allows patients to receive their results more quickly. 

Quests test, which was originally authorized on March 17, remains authorized to test individual samples collected by an individual’s healthcare provider from those with suspected COVID-19. 

“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,” FDA noted.

Sample pooling is an important tool, especially during a crisis like COVID-19. 

In a recent TIME article, Peter Iwen, director of the Nebraska Public Health Laboratory, explained that pooled testing may save on reagents, the chemical substances needed to run COVID-19 tests.   

Because pooled testing was effective in the past for STDs, Iwen believed that there was potential for use for COVID-19. 

In mid-March, Iwen ran pooled sample tests, each time taking a sample from a patient with confirmed COVID-19 who had low levels of the virus in the sample, and added it to four other samples that were negative for COVID-19.

Each time, he picked up a positive sample.

Iwen then received the governor of Nebraska’s authorization to start using pooled testing in the public health lab Iwen oversees. Days later, he also received authorization from the FDA to start testing in pools of five samples each.

Additionally, in a study published in the Journal of Infectious Diseases, Chris Pilcher, professor of medicine at the University of California, San Francisco, found that pooling could increase efficiency by testing anywhere from two to 20 times the number of samples compared to individual testing.

“I think that pooled testing is something that is going to be needed,” said Pilcher. 

“As people return to work, school and large group activities, pooled testing could be a way to conduct regular testing without overloading the lab network. Employers, schools, nursing homes and hospitals may want to repeat testing on a regular basis to ensure people are protected from infection, and relying on pooled testing would make this feasible.”