(RxWiki News) The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for a new COVID-19 diagnostic test that can test people who are not showing symptoms.
This test is found under the name LabCorp COVID-19 RT-PCR.
This test was originally given an EUA in early March. It was to test those whose health care providers suspected that they might have COVID-19, and it only tested individual specimens (no sample pooling). But that changed with this new EUA from the FDA.
Now, this diagnostic option can be used for two new things:
- Testing for those who do not have COVID-19 symptoms or who have no reason to suspect COVID-19 infection
- Testing pooled samples (containing up to five individual swab specimens)
These new indications come after data revealed that this test can detect SARS-CoV-2 in people who are not showing any symptoms.
The fact that the test allows sample pooling means fewer tests overall. This saves resources and offers quicker results.
“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 FDA Commissioner Dr. Stephen M. Hahn in a press release.
This test is available by prescription only and requires nasal swabs or sputum specimens. This test can be completed by a health care provider or at home with the use of Pixel by LabCorp or other approved home sample collection kits. Only a health care provider can conduct pooled sampling, however.