Amid the dozens of tests for Covid-19 to which the Food and Drug Administration has given emergency use authorizations, the agency said Tuesday that it had given the go-ahead for the first test to include an at-home sample collection option.
The FDA said it reissued the EUA it had given to LabCorp last month for its RT-PCR test to allow for collection of samples at home, using the company’s Pixel by LabCorp Covid-19 Test kit, as long as patients have a doctor’s order. The kits will become available in the coming weeks, the FDA said.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” FDA Commissioner Stephen Hahn said in a statement. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers.”
Hahn added that it worked with LabCorp to ensure that data showed at-home sample collection was as safe and accurate as collecting samples in a doctor’s office, hospital or other site. The collection kit includes a special cotton swab for collecting a nasal sample, which can be mailed in an insulated package to a LabCorp lab.
The decision by the FDA follows earlier announcements by some companies that they would start distributing at-home tests to consumers, especially amid a nationwide shortage of available tests for people who think they have or are at risk of contracting SARS-CoV-2, the virus that causes Covid-19 – even doctors and nurses. However, following those announcements, the FDA issued a March 23 guidance to warn the public that it had not given authorizations to any at-home tests. Four days later, the agency issued another guidance saying that it would allow patients to swab themselves to test for the Covid-19 virus, but not at home.
Most of the tests that have received EUAs from the FDA have been RT-PCR assays. However, it has also given an authorization for Abbott’s rapid test, which uses a different method more suitable for use in smaller settings like urgent care centers, though that test has limited availability around the country, with Kaiser Health News reporting earlier this month that fewer than 6,000 were available. Another method is serological testing, which could detect whether someone had been infected before by looking for antibodies in the blood against Covid-19.
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