Getting tested for COVID will be a lot like buying Tylenol in the next few weeks, without an appointment or prescription. The Food and Drug Administration recently granted emergency use authorization for two types of rapid result over-the-counter COVID-19 tests. However, these OTC test results are not as accurate as polymerase chain reaction (PCR) tests, which require a laboratory to process.
“‘Negative results should be treated as presumptive.’ ”- Food and Drug Administration
And now a word of caution: “Negative results should be treated as presumptive,” the FDA said in its authorization letters for the Abbott and Quidel home tests. “Do not rule out SARS-CoV-2 infection,” he said, adding that such over-the-counter tests should not be used as the sole basis for treatment or patient management. “People who test negative and continue to experience COVID-19-like symptoms of fever, cough, and / or shortness of breath may still have SARS-CoV-2 infection and should seek follow-up care with their doctor or provider. health care, “the FDA said. . How much will they cost? Currently, the only two home tests that do not require a prescription or telehealth provider to monitor are Quidel’s QDEL, QuickVue test + 0.77%, and Abbott’s BinaxNOW COVID-19 Antigen Self Test ABT, + 0.15%. A Quidel spokeswoman told MarketWatch that the company is “looking to bring these tests to market by the end of April at a price of less than $ 30 for a two-test kit configuration (less than $ 15 / test).” The company has not announced where the tests will be sold.
“Over-the-counter tests, which will include supplies to run two tests, will likely cost between $ 10 and $ 15 per test. ”
Abbott’s BinaxNOW Self-Test “will be available nationwide and in bulk at major national food, drug and mass-merchandise retailers and will be priced affordably, similar to common over-the-counter (OTC) tests.” , a March 31 statement released by Abbott states. “The test will come in a two-unit box to meet (frequent) serial testing requirements,” the company said in a statement. An Abbott spokesperson told ABC News: “The tests are expected to be sold in packs of two and cost less than $ 10 per test.” Abbott did not respond directly to MarketWatch’s inquiry about the price of the tests and when consumers could expect to buy them. “With continued demand for testing, we continue to evaluate newly approved products that could provide our customers with additional convenient and affordable options,” CVS CVS spokesperson Matt Blanchette told MarketWatch -0.29%. Walgreens WBA, + 0.61% did not respond to MarketWatch’s request for comment.
A step-by-step guide included in the Quidel QuickVue test that delivers results in ten minutes. Quidel
How will they work? Both tests should only be used for asymptomatic individuals, as the FDA has not granted emergency approval for symptomatic individuals. The Quidel QuickVue test includes enough supplies to run two tests, ideally spaced 2-3 days (but no more than 36 hours apart) for the most accurate results. Similar to tests performed by physicians, a cotton swab is rotated inside the wall of each nostril four times over 15 seconds with the same swab. Next, insert the swab into a tube that includes a test strip and a reagent solution designed to detect a positive or negative COVID-19 result after ten minutes.
“Over-the-counter test results are not as accurate as polymerase chain reaction (PCR) tests, which require a laboratory to process them. ”
A positive result should show a blue line and a pink line on the test strip. Whereas a negative result should only show a blue line. The test is considered invalid “if at 10 minutes, the blue control line does not appear, even if some shade of the test line appears from pink to red”, the positive results of your OTC test matched the reaction tests laboratory standard polymerase chain (PCR) 83.5% of the time, and negative results were consistent 99.2% of the time, based on clinical testing the company conducted and shared with the FDA that it did not they were peer reviewed. The Abbott BinaxNOW Self Test works in a similar way, with a few minor differences. (You can read more about them here). Like Quidel’s OTC test, Abbott’s also includes all supplies for two tests no more than 36 hours apart. Instead of putting the swab in a tube, place the swab on a test card. After 15 minutes, if two pink / purple lines appear, it means that COVID-19 was detected. If only one appears, then it was not detected.
Shown here is Abbott’s BinaxNOW COVID-19 self-test, which provides results in 15 minutes. Abbott