At-home COVID-19 test.Photo: Getty
Getting aCOVID-19test amid the ongoing pandemic is about to become a lot easier.
On Tuesday, theFood and Drug Administration (FDA)authorized the first at-home COVID-19 test that doesn’t require a prescription. It will soon become available to purchase nationwide, according to apress releasefrom the organization.
A company spokesperson told theAssociated Pressthat the new at-home test will be available at pharmacies and for purchase online, and will be priced around $30.
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“Today’s authorization is a major milestone in diagnostic testing for COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “By authorizing a test for over-the-counter use, the FDA allows it to be sold in places like drug stores, where a patient can buy it, swab their nose, run the test and find out their results in as little as 20 minutes.”
Hahn added: “As we continue to authorize additional tests for home use, we are helping expand Americans' access to testing, reducing the burden on laboratories and test supplies, and giving Americans more testing options from the comfort and safety of their own homes.”
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“The FDA strongly supports innovation in test development and we have worked tirelessly with test developers to support the shared goal of getting more accurate and reliable tests to Americans who need them,” noted Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “Today is a promising step forward and we are eager to continue advancing additional innovation in COVID-19 testing that the science supports.”
“This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab,” he continued. “However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”
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Ellume said that it plans to produce millions of tests next month, per the AP.
According to the product’s online listing, the at-home testing kit comes with a sterile nasal swab, a dropper and processing fluid, as well as an analyzer that connects to an individual’s smartphone through Bluetooth and an associated app.
After administering the test, the application will share the users' results and even offer them an opportunity to connect with a healthcare professional. The app also sends data to health officials, who can track positive cases.
“This is the first test which is really designed to be a true at-home test yourself and obtain a result,“Sean Parsons, the company’s CEO, told NPR in an interview prior to the product’s authorization. “This could be used for people to test themselves, for example, before going to a sporting event or a concert or going to a church to decrease the chance that they spread it other people.”
But, per the FDA release, “a small percentage of positive and negative results from this test may be false,” as is the case with other COVID-19 tests.
Coronavirus.Getty
The Ellume approval comes after theFDA approved the first rapid at-home coronavirus test, which can give users results within the hour, last month.
According to the agency, theLucira COVID-19 All-In-One Test Kitcan be obtained with a prescription for patients 14 or older, and will return results in about 30 minutes. The test can also be administered to patients of all ages at a “point-of-care (POC) setting,” such as a hospital or clinic.
On their website, Lucira Health states that the tests have a sensitivity (how well it detects positive cases) of about 94.1 percent and a specificity (how well it detects negative cases) of 98 percent.
As information about thecoronavirus pandemicrapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from theWHOandlocal public health departments.PEOPLE has partnered with GoFundMeto raise money for the COVID-19 Relief Fund, a GoFundMe.org fundraiser to support everything from frontline responders to families in need, as well as organizations helping communities. For more information or to donate, clickhere.
source: people.com
