What you should know about rapid at-home COVID tests

Biden Administration betting big on at-home tests
Posted at 9:37 PM, Mar 02, 2021
and last updated 2021-03-03 22:35:56-05

SAN DIEGO (KGTV) -- A San Diego company just got emergency authorization from the Food and Drug Administration to sell a self-test for COVID-19 that returns results in 10 minutes, entirely from home.

Initially, the QuickVue At-Home COVID-19 Test from Quidel Corporation will only be available with a doctor’s prescription, but the company will pursue a second authorization in the coming months to sell the test over-the-counter, according to CEO Douglas Bryant.

“If we can test frequently at home, we can protect communities and make it safe for all of us to go to restaurants and schools,” he said in an interview.

Fully at-home tests like Quidel’s are a newly emerging part of the diagnostic landscape, one the Biden Administration says will be crucial to getting life back to normal.

For months, consumers have had access to dozens of “home collection tests,” where users swab themselves and mail back samples to an outside lab for processing. But at-home tests that offer rapid results on the spot like a pregnancy test are not yet widely available.

Quidel’s test is the fourth authorized by the FDA in recent weeks. Other tests include the Lucira COVID-19 All-In-One-Test Kit, the Ellume COVID-19 Home Test, and the BinaxNOW COVID-19 Ag Card Home Test.

Compared to the development of vaccines, testing has evolved at a slower pace. Critics point to the amount of federal funding allocated during the Trump Administration. As of last August, the National Institutes of Health had awarded $374 million to testing companies, compared to the $9 billion pledged to vaccine makers.

“The country is well behind where we need to be in testing, particularly the rapid at-home tests that will allow us all to get back to normal activities like work and school,” Tim Manning, a member of the White House COVID Response Team, said last month.

The Biden Administration is trying to boost production. The administration announced last month an agreement to purchase 8.5 million at-home tests from an Australian company called Ellume for $231 million. Ellume’s test is the only one currently authorized for use without a prescription.

The administration said it was in talks with six other unnamed companies to generate 61 million tests by the end of the summer.

Bryant said he could not confirm if Quidel is one of the six finalists, but said the company had been in talks with the federal government about purchasing rapid at-home tests and provided quotes. Quidel has not yet publicly announced the price of the QuickVue test.

Like most rapid tests, Quidel’s QuickVue is an antigen test, which detects surface surface features on the virus.

Antigen tests trade speed for accuracy relative to the slower polymerase chain reaction (PCR) tests that are considered the gold standard. PCR tests amplify tiny bits of genetic material, a process that improves sensitivity but requires a lab and adds time.

Quidel says its rapid tests line up with PCR results more than 96 percent of the time in people experiencing symptoms. However, in asymptomatic people, one study found the test caught positive cases just 41.2 percent of time.

“The healthcare community understands that the accuracy may not be perfect, but if we have the ability to test frequently, that frequency of testing overcomes the lack of perfection,” Bryant said.

The FDA’s authorization on Monday permits Quidel to offer the test with a doctor’s prescription to people within six days of their first symptoms. Bryant said the authorization would allow the company to take part in several clinic trials that will support an over-the-counter application, including one trial using a companion phone app to help users interpret results.

In the meantime, he said doctors could prescribe a “blanket” prescription for the test, allowing individuals without symptoms to get access.

“Under a blanket prescription, the physician can authorize use for the test as they see fit,” he said.

Quidel is ramping up production of these tests with the help of a new manufacturing facility in Carlsbad. By the fourth quarter of this year, they plan to produce more than 50 million QuickVue rapid tests each month.