The Food and Drug Administration on Friday reissued an emergency use authorization for a test to detect people without symptoms of covid-19, the disease caused by the new coronavirus. This authorization, the first for this type of test, is intended to allow asymptomatic individuals who have no symptoms and no reason to believe they may be infected to be tested.
Real-time PCR LabCorp performs the test that received authorization for emergency use and initially received authorization from the FDA mid March for use only in people suspected of having covid-19. However, this reissued authorization allows LabCorp to use the test on anyone, not just on people suspected of having covid-19 by their healthcare provider. The FDA said it expanded the use of the LabCorp test after the company provided data demonstrating the test’s ability to detect SARS-CoV-2 in an asymptomatic general population.
According to the FDA, the data provided by LabCorp states that the test is as accurate when used with the asymptomatic population as it is among people suspected of having covid-19.
Additionally, the FDA will also allow LabCorp to perform group tests, allowing the laboratory to analyze up to five patient samples at a time using a single test. This is the second test that the FDA has authorized to pool test in recent weeks. The agency considers group testing to be an important public health tool because it allows more people to be tested quickly using fewer resources.
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In a statement, FDA Commissioner Stephen Hahn emphasized that asymptomatic testing was an important factor in reopening schools and workplaces.
“The FDA clearance of the first diagnostic test to be used for anyone, regardless of whether they show symptoms of covid-19 or have other risk factors for exposure, is one step toward the type of comprehensive screening that can help to allow the reopening of schools and workplaces, ”said Hahn.
His comments are not surprising given the absolutely appalling insistence of the Trump administration that children return to school. After threatening to cut funds For schools that did not fully reopen, President Donald Trump recently armed The Centers for Disease Control and Prevention backs up its call to reopen schools after calling the agency’s initial guidelines for its reopening “very difficult and expensive.”
Riiiight. It doesn’t matter if children, teachers, staff, and even parents get sick and possibly die. As long as people get back to work.
The FDA noted that, Until now, coronavirus testing has generally been authorized for people suspected of having covid-19 by their healthcare provider. However, the LabCorp trial remains prescription only. Samples can be collected using home sample collection kits and by a healthcare provider. Additionally, the FDA said that only samples collected by a healthcare provider can be processed in a group at this time.
“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 agency said in a statement.
While that may be a good step forward, it’s difficult to understand how to authorize a new coronavirus test at a time when US labs are facing overwhelming demand for testing and shortage of supplies help to. It seems that one of the best solutions in this situation could be to try download cases practicing social distancing and wearing a mask. What thought.
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