FDA approves at-home COVID test
By Dave Goldiner
New York Daily News |
Mar 01, 2021 at 10:57 AM
An at-home test for coronavirus Monday won emergency use approval from the federal Food and Drug Administration. The Quidel QuickVue test got the green light as the government seeks to make it easier for Americans to determine if they have been infected with the deadly virus. “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Dr. Jeff Shuren, an FDA official.
The nasal swab test can be self-administered by anyone over 14 years old or performed by a parent on anyone over eight. It’s designed for use by patients whose health care providers believe have been infected. The FDA said it can detect the presence or absence of COVID-19 within the first six days of when the patient experiences symptoms.
It’s the second approval for tests outside of hospitals by Quidel. The company won approval for their QuickVue SARS Antigen Test which is designed for use in laboratories as well as for point-of-care testing.
Some public health experts are concerned that fewer COVID tests are being administered as infection rates decline after a major holiday surge.
https://www.nydailynews.com/coronavirus/ny-covid-fda-approval-quidel-quickvue-test-20210301-cb3nintrjzg4reuhxiae3oqldq-story.html
Also as a note - I found this (apparently this is a
presciption-required test) -
Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test
News provided by
U.S. Food and Drug Administration
Mar 01, 2021, 09:24 ET
SILVER SPRING, Md., March 1, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.
The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset.
"The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic," said Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health. "The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public."
In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for their QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver.
https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-issues-authorization-for-quidel-quickvue-at-home-covid-19-test-301237456.html
This is apparently an antigen test.
= new reply since forum marked as read
