Getting a COVID test will feel like buying Tylenol in the coming weeks – no prescription or prescription is required.
Recent Food and Drug Administration granted Emergency authorization for two types of over-the-counter quick results COVID-19 assays.
However, these over-the-counter test results are not as accurate as polymerase chain reaction (PCR) tests, which require laboratory processing.
Consumers pay for two checks per package. The companies say this is to help provide more accurate results, and recommend testing again in 36 hours.
FDA has granted emergency use to people to take cotton swabs themselves if they are 14 or 15 years old or older, depending on the type of test used. It takes 10 to 15 minutes for the test results to appear.
‘Negative results should be considered hypothetical.’
And now a warning: “Negative results should be considered hypothetical,” the FDA said in authorization letter for Abbott and Quidel home trials.
“Does not exclude SARS-CoV-2 infection”, adding that such over-the-counter tests should not be used as the sole basis for the treatment or management of patients.
“Individuals who test negative and continue to experience COVID-19 such as fever, cough and / or shortness of breath may still be infected with SARS-CoV-2 and should seek follow-up care with their doctor or healthcare provider, ”the FDA said.
How much will they cost?
Currently, the only two home tests that do not require a prescription or a supervised remote health care provider are those of Quidel.
QuickVue Test and Abbott BinaxNOW COVID-19 Antigen Self-Test
A Quidel spokesperson told MarketWatch that the company was “looking to bring these tests to market by the end of April for under $ 30 for a two-test set configuration (under $ 15 / test). solution) ”.
The company hasn’t announced where to sell the prototypes.
The over-the-counter tests, which include supplies for performing two tests, will likely cost between $ 10 and $ 15 per test.
Abbott’s BinaxNOW Self Test “will be available nationally and in bulk at national mass food, drug, and merchandise retailers and will be affordable, similar to the over-the-counter tests. standard form (OTC), “a March 31 statement published by Abbott as a Status.
The test will come in a two-digit box to meet serial (regular) testing requirements, the company said in a statement.
Abbott spokesperson told ABC News that “the tests are expected to be sold in packs of two and will cost less than $ 10 dollars per test.”
Abbott did not respond directly to MarketWatch’s questions about prices for the tests and when consumers will be able to buy them.
“With the need for ongoing testing, we continue to evaluate new approved products that can offer our customers convenient and affordable add-on options,” said Matt Blanchette, a CVS.
a spokesman told MarketWatch.
did not respond to MarketWatch’s request for comment.
How will they work?
Both tests should be used only for people who don’t have symptoms, as the FDA has not granted emergency licensing to people with symptoms.
Quidel’s QuickVue test includes enough supplies to run two tests – ideally 2 to 3 days apart (but no more than 36 hours apart) for the most accurate results.
Like the tests done by a doctor, swab your nostrils 4 times in 15 seconds using a cotton swab.
Then, insert the swab into a tube containing a test strip and reagent solution designed to detect positive or negative COVID-19 after ten minutes.
The results of the over-the-counter test are not as accurate as the polymerase chain reaction (PCR) test, which is required by the lab.
A positive result should show both the blue and pink lines on the test strip. While negative results show only a blue line.
The test is considered invalid “if, after 10 minutes, the blue Control Line does not appear, even if any pink to red Test Line shadows appear,”
According to the clinical examination the company did and shared it with the FDA without peer review.
Abbott’s BinaxNOW self-test works similarly, with some minor differences. (You can read more about them here.)
Like Quidel’s OTC test, Abbott also comes with all the supplies to perform two tests no more than 36 hours apart. Instead of placing a cotton swab in a tube, you put a cotton swab on a test card.
After 15 minutes, if two pink / purple bars appear, COVID-19 has been detected. If only one appears it is not detected.