The Food and Drug Administration on Saturday granted “emergency use authorization” to a new coronavirus test kit that allows people to submit self-collected nasal samples to laboratories by mail.
The new test, by Everlywell Inc, is the third home sample collection kit, with special expedited FDA approval under an emergency use authorization – which uses a lower standard than that to which the FDA normally adheres for new treatments and products, but allows for the use of articles, the administration believes that it is “reasonable to believe” that it will be effective during a public health emergency. The company has already faced questions in Congress after appearing to market a similar product for home use without FDA review; he told the New York Times that he wants his kits to be used only by healthcare providers while waiting for federal approval.
The emergency use authorization will increase the number of credible sample collection kits that Americans can use to test from home, allowing them to avoid the risk of exposure in a medical facility, and also reduce the chances of spreading the virus if they are actually positive.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said that the speed at which the administration was able to give the green light to the kit “was an excellent example of public-private partnerships, in which data from private sector study used by industry to support EUA [emergency use authorization] request. “
Here’s how the testing process works, as reported by the New York Times: someone who wants to be tested responds to an online survey to make sure they meet federal guidelines for receiving a test. These guidelines suggest that a person should have symptoms or have been in contact with symptomatic people before requesting screening.
The results of the online survey are then reviewed by health care providers affiliated with Everlywell’s telemedicine partner. If the investigation shows that the person is at risk of infection, the collection kit is shipped immediately. The recipient of the kit collects a nasal sample, places it in saline, and ships it overnight to a certified laboratory. The entire process, from taking the survey to getting the results, should take three to five days. Each kit costs $ 135 and, according to Everlywell, will be available in late May.
There are two other home sample collection kits that have also received emergency clearance from the FDA; one also uses nasal samples and the other uses saliva.
As Sara Morrison of Recode reported, the FDA is working to grant emergency use clearances in part to repel fraudulent vendors who make false claims about home testing.
“In late March, the FDA even issued a harsh warning to American consumers to be on the lookout for unauthorized or fraudulent test kits,” Morrison wrote. “One company, MicroGen DX, later said [STAT News] that he did not need FDA clearance for his home collection test at all. The FDA has also cracked down on unauthorized test shipments from other countries. “
The FDA has not authorized any tests that can be done entirely at home – that is, the collection of samples and the diagnosis. While a number of companies are working on such tests, experts estimate that home tests with quick results could take months.
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