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The first COVID-19 diagnostic test that can be administered at home has been authorized by the U.S. Food and Drug Administration, according to an agency statement issued Tuesday.
The tests by Laboratory Corporation of America (LabCorp) will initially be made available to health care workers and first responders who might have been exposed to the coronavirus or who have symptoms of the disease. LabCorp plans to make the self-collection kits available to consumers “in the coming weeks,” the company said in a separate statement.
People interested in obtaining the at-home test can sign up for email notification on the company’s website. LabCorp is charging $119 per kit.
The FDA authorized the test on Monday. The go-ahead, which is good for the duration of the pandemic emergency, is a reissue of an emergency-use authorization the regulatory agency had given LabCorp on March 16 for its COVID-19 RT-PCR Test, which was not at that time allowed to be used for at-home testing.
The reissue allows testing of a sample collected from the patient’s nose using LabCorp’s Pixel by LabCorp COVID-19 Test home collection kit with a doctor’s approval. The kit contains specific Q-tips-style cotton nasal swabs and saline. Patients collect their nasal sample and mail it in an insulated package to a LabCorp lab for testing.
The approval is not a general authorization for at-home collection of patient samples using other collection swabs, media or tests, or for tests fully conducted at home, the FDA noted. The test also isn’t like a pregnancy test, which gives the user an instant color-change to verify a positive result.
The FDA has authorized more than 50 diagnostic tests related to the coronavirus and has worked with more than 350 test developers. The agency required LabCorp’s data to ensure that the at-home patient sample collection is as safe and accurate as sample collection conducted at a doctor’s office, hospital or other testing site.
“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 Dr. Stephen M. Hahn said in the statement.
LabCorp is headquartered in North Carolina and has satellite offices throughout the Bay Area including in Palo Alto and Mountain View. The FDA authorization states that the tests will be performed at the company’s lab in Burlington, North Carolina, and other certified LabCorp laboratories; however, it was not clear whether any such labs were in the Bay Area.
Find comprehensive coverage on the Midpeninsula’s response to the new coronavirus by Palo Alto Online, the Mountain View Voice and the Almanac here.
Will most medical insurance programs cover these tests or are they for rich people only?
Define rich people.
I know some who consider having medical insurance a thing that rich people have.
What are the differences between nose swab test vs throat swab test?
Earlier, under pressure from the country’s Chief Doctor, President Trump, FDA authorized emergency use of antimalarial drugs for COVID-19 without any
data or studies to support that. Therefore, the credibility of FDA is LOW.
Why can’t these tests be sent to our primary care physicians to be administered? At-home temperature checks can be done with a thermometer.