The U.S. Food and Drug Administration (FDA) has just approved the first new coronavirus test kit for families that can quickly deliver results,media BGR reported. Lucira Health kits will cost less than $50 and should be available nationwide in the spring through health care providers. Anyone over the age of 14 can use the kit, which will provide diagnostic results within 30 minutes.
According to the FDA’s announcement, the kit includes everything you need to test for COVID-19 at home, and it’s suitable for anyone at least 14 years old. People will have to use cotton swab to collect samples from inside their noses. They will then place the cotton swab in a vial, rotate it, and place the vial in the test unit, as shown in the following image. The results should be processed within 30 minutes.
“Now, more Americans who are likely to have COVID-19 will be able to take immediate action based on their results to protect themselves and those around them,” said Jeff Shuren, FDA’s medical device director. Importantly, health care providers who prescribe tests will have to report the results to public health authorities. This is actually a function that exceeds the expectations of the rapid COVID-19 test and should help local authorities better estimate the local spread of the new coronavirus.
The test is not perfect and may result in some incorrect results. Politico noted that the description of the test explained that in one study, it correctly identified 94 percent positive and 98 percent negative samples using more sensitive laboratory-based tests. “Excluding samples with low viral levels that may no longer reflect active infections, Lucira achieved a 100% positive percentage consent rate,” the note states. “
Some experts believe that extensive home testing may help bring the epidemic under control in the United States. “I’m very firmly convinced that if we ask 100 percent of Americans — maybe we won’t get there — to be tested every week, we can do that,” Michael Mina, an epidemiologist at Harvard University, told Politico. He added that a second home test could be conducted using different methods to reduce the number of false positives.
The test kit will cost less than $50 to manufacture in the United States. The first locations to receive the test will be Sutter Health in Northern California and the Cleveland Clinic in Florida. It should be available nationwide in spring 2021. More details about the test are available on the Lucira Health website.