Towards the end of last week, the Food and Drug Administration granted a green flag for two more home tests that can be bought over-the-counter, in order to detect a possible COVID-19 infection. The newest of the tests to be approved are Abbott’s BinaxNow and Quidel’s QuickVue.
In an effort to make a slew of home tests widely available for citizens to test themselves for the virus at home, the FDA made the decision to authorize two new tests last week, under the backdrop of a decline in testing numbers, and a rise in coronavirus infections. Dr. Michael Mina of Harvard said the expanded testing options would be critical as new virus variants spread and researchers study how long protection from vaccines lasts.“Vaccines are incredibly important but they are not the end-all, be-all to this pandemic,” Mina said. “We need other tools in our arsenal and the widespread availability and rapid scale-up of tests for people to use in the privacy of their homes is going to be an extraordinary gain.”
The FDA said Abbott’s BinaxNow and Quidel’s QuickVue tests can now be sold without a prescription. Both tests were first OK’d last year but came with conditions that limited their use, including prescription requirements and instructions that they only be used in people with symptoms. The home tests allow users to collect a sample themselves with a nasal swab that is then inserted into a test strip. Results are usually available in 10 to 20 minutes. Most other COVID-19 tests require a swab sample taken by a health worker at a testing location.
Abbott said its test would sell in “single digits” per test and should be available in “coming weeks” at pharmacies, supermarkets, and other chains. The company can produce about 50 million tests per month. Quidel did not disclose pricing for its test. Both companies said they would sell their tests in two packs. Repeat testing is considered crucial to reducing the chance of false results. Both tests can be used by adults to test children 2 years and older.
Apart from authorizing these home tests, last week, the FDA also announced a pilot testing program to study the use of rapid home testing to slow infections in U.S. communities. The program will provide free home tests to as many as 160,000 people in two counties in North Carolina and Tennessee.