The U.S. Food and Drug Administration (FDA) has authorized another at-home coronavirus test for emergency use authorization.
The test, made by Quidel Corp, can only be gotten with a prescription but does require users to send a sample to a laboratory for analysis.
What’s more, it can provide results within 10 minutes, which makes it an easy option that could be offered at schools and businesses across the country.
The announcement of the approval is another important, albeit small, step to increase the number of testing options available in the U.S.
Quidel Corp’s at-home coronavirus test received emergency use authorization from the FDA on Monday, but it does required a prescription
Users collected a nasal sample (above)and then a few drops of the solution are added. Results are available within 10 minutes, with a blue line indicating a negative COVID-19 test and a red line indicating a positive test
‘The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,’ said Dr Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in a news release.
‘The QuickVue At-Home COVID-19 test is another example of the FDA working with test developers to bring important diagnostics to the public.’
For months, health experts have stressed that the U.S. needs fast and widespread home screening so that anyone who has come into contact with a COVID positive person can isolate quickly and find out if they’ve become infected.
However, most tests on the market require a nasal swab that is performed by a health processional and is processed at a laboratory, which means results can take days to return.
There are at least 25 tests out there that allow the public to collect their own samples at home, but still need to be shipped to a laboratory.
Currently the U.S. is testing about 1.3 million people daily, but experts say many more tests need to be performed to curb the pandemic.
Users aged 14 and older can collect a nasal swab by themselves and an adult can collect for children between ages eight and 13.
Quidel’s test looks for viral proteins shed by COVID-19, which is different from the gold-standard approach of tests that look for the genetic material of the virus.
To receive the test, doctors or other healthcare providers must prescribe the test within the first six days after symptoms begin.
The test comes with 25 rapid antigen test strips and reagent solution.
The nose sample is collected with an adapter and then a few drops of the solution are added to the sample.
Within 10 minutes, results are available. A blue line indicates a negative COVID-19 test and a red line indicates a positive test.
In clinical studies, the test demonstrated 92 percent overall accuracy, correctly identifying 84.8 percent of positive cases and 99.1 percent of negative cases.
The company said its new factory in Carlsbad, California, which opens in the second half of 2021, expects to produce 600 million of its tests per year.
In studies, the test demonstrated 92% accuracy, correctly identifying 84.8% of positive cases and 99.1% of negative cases
‘The flexibility of our QuickVue At-Home COVID-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection,’ Douglas Bryant, president and CEO of Quidel Corporation, said in a statement.
‘We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.
Quidel is at least the third company to have an EUA granted for a kit that allows self-testing at home and that provides rapid results.
The first test, Lucira, was approved by the FDA in mid-November and Ellume, which does not require a prescription, was approved in mid-December.