USFDA AUTHORISES FIRST AT HOME COVID 19 SELF TEST
18 nov 2020
On tuesday an emergency green light was given to the food and drug administration the corono virus test was increasing rapidly and it has to start to finish from home.
Age under 14 can't test the kits.
The test, developed by California-based company Lucira Health, requires a prescription from a health care provider.Clinicians can also run the test on their patients, including children under 14, potentially delivering answers during a single visit to a care center or pharmacy, instead of routing a tough-to-collect sample through a lab.
Jeff Shuren, Director of FDA’s Center for Devices and Radiological Health said that “Today’s authorization for a complete at-home test is a significant step toward FDA’s nationwide response to Covid-19,”.
Now, more Americans who may have Covid-19 will be able to take immediate action, based on their results, to protect themselves and those around them.”he added. Omai Garner, a clinical microbiologist and diagnostics expert at the University of California, Los Angeles Health System said that An at-home test for the virus “was going to happen,” and “I am hopeful that it works well.”
Representatives at Lucira Health did not respond immediately to requests for comment.According to the product’s instructions, Lucira’s LAMP test was able to accurately detect 94% of the infections found by a well-established PCR-based test.
It also correctly identified 98% of the healthy, uninfected people. According to the strategy that would likely rely on tests that sacrifice a degree of accuracy for convenience and a more affordable price tag.