“FDA’s authorization of the first diagnostic test to be used for anyone, regardless of whether they are showing symptoms of COVID-19 or have other exposure risk factors, is a step toward the type of broad screening that may help enable the reopening of schools and workplaces,” said Stephen M. Hahn, the FDA commissioner, in an announcement on July 24.
The test will detect COVID-19 molecules in swabs or cell samples collected from an individual’s respiratory system, according to the FDA.
The agency said that companies and organizations may want to conduct tests in order to screen out asymptomatic individuals as a way to keep workplaces safe. In June 2020, the FDA updated its guidelines with recommendations for test developers to encompass screening for individuals whose conditions are asymptomatic, as well as for pool testing purposes.
FDA made this decision to expand the testing range after the company, LabCorp, had provided scientific data that the test was able to detect the presence of COVID-19 in asymptomatic individuals, as well as the general public. The test data was then reviewed by the FDA, and they “demonstrated that the test is as accurate in the broader asymptomatic population as it is among people suspected to have COVID-19.”
The diagnostic test will be extended to accommodate sample pooling testing.
Sample pooling is a method of testing multiple people at once. The samples collected from multiple individuals are tested in a pool using one test, rather than each individual sample having its own test.
The FDA indicated that by expanding the testing range of the tests for sample pooling, a considerable amount of resources that would have otherwise gone to regular testing is saved. This also means that the FDA could run even more tests.
LabCorp indicated that the diagnostic tests are limited only through prescription and can be used either at home with the use of the Pixel, which is developed by LabCorp, or other sample collection kits either authorized by LabCorp or a medical professional.
However, as of current, LabCorp indicated that the sample pooling is something that can only be done by health care providers.
“By authorizing another test for use with pooled samples, we also further help increase the possibility that patients may be able to receive results sooner, while also conserving vital testing supplies, which are under increased demand during the pandemic. Continuing to facilitate increased access to accurate and reliable tests for all Americans is critically important and the FDA continues to work around the clock with test developers to support this goal,” said Hahn.