- For immediate publication:
Today, the US Food and Drug Administration reissued the Emergency Use Authorization (US) LabCorp COVID-19 RT-PCR Test to include two new indications for use: tests for people who do not have symptoms of COVID -19 or who have no reason to suspect COVID-19 infection, and to allow testing of pooled samples. The FDA reissued the LabCorp COVID-19 USA RT-PCR test to expand the use of the test to anyone, after the company provided scientific data showing the test’s ability to detect SARS-CoV-2 in an asymptomatic general population. In addition, the new issue includes authorization for LabCorp to analyze pooled samples containing up to five individual swab samples collected under observation. Pooling samples allows you to run fewer tests overall, conserving resources and potentially allowing more samples to be evaluated more quickly.
“The FDA clearance of the first diagnostic test to be used for anyone, regardless of whether they show COVID-19 symptoms or have other risk factors for exposure, is one step toward the type of comprehensive screening that can help allow the reopening of schools and workplaces, “said FDA Commissioner Stephen M. Hahn, MD” By authorizing another test for use with pooled samples, we also help increase the chance that patients may receive results sooner, while maintaining vital testing supplies, which are under increasing demand during the pandemic. Continuing to facilitate greater access to accurate and reliable evidence for all Americans is vitally important, and the FDA continues to work 24-hour with test developers to support this goal. “
The FDA recognizes that organizations may want to screen asymptomatic individuals as part of a broader strategy to help ensure the safety of their employees, patients, students, and others. Last month, the FDA released updated templates with recommendations for test developers to demonstrate validation of an authoritative test for screening for asymptomatic individuals, as well as for pooling samples. Last week, the FDA cleared the first COVID-19 test that could be used with pooled samples.
The LabCorp test is maintained by prescription only and is authorized for collection of human samples at home using Pixel by LabCorp or other authorized home sample collection kits for use with the LabCorp test, or by a provider of medical attention. However, only samples collected by the healthcare provider can be pooled at this time. Additionally, data reviewed by the FDA demonstrated that the test is as accurate in the broader asymptomatic population as it is among people suspected of having COVID-19.
The LabCorp test was originally issued with a US on March 16 for use only in individuals suspected of having COVID-19 by their healthcare provider and to analyze individual samples without pooling of samples. Until now, molecular diagnostic tests have generally been authorized for people suspected of having COVID-19 by their healthcare provider, allowing asymptomatic individuals to undergo testing, when warranted, at the discretion of the healthcare provider. medical. Today’s authorization eliminates the need for a provider to consider risk factors such as exposure or community spread when prescribing this test. The FDA continues to work with test developers to expand access to COVID-19 tests.
The FDA, an agency within the US Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and safety of medicines, vaccines, and other biological products for human use and medical devices for humans and vets. The agency is also responsible for the security of the supply of food, cosmetics, dietary supplements, products that emit electronic radiation from our country and for regulating tobacco products.
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