Updated: August 28, 2020 06:12 PM
Created: August 28, 2020 05:15 PM
The U.S. Food and Drug Administration authorized a new COVID-19 test that operates similar to a pregnancy test and can deliver results within 15 minutes.
The test, called BinaxNOW, was developed by Abbott Laboratories, a global health care company that has a location in Minnesota.
"This is really an important advance in testing," said Dr. John Hackett, divisional vice president of applied research and technology at Abbott.
The test involves a nasal swab, although the developers said it is one that can be done in the front of the nose and is significantly less uncomfortable than other tests.
Unlike other tests, the specimen does not have to go to a lab and does not require any extra supplies.
"It's the only rapid antigen test available in the United States that doesn't require instrumentation," Dr. Hackett said. "No extra chemical reagents are required besides what comes with the test kit, which keeps the number of components to a minimum and removes the possibility of delays due to supply chain issues."
The nasal swab is inserted into a credit card-sized "Ag card" and a liquid reagent is added using a dropper. Then, lateral flow technology, which is what is used in pregnancy tests, reveals the results on a reactive card. One line on the card means the test is negative. Two lines mean it is positive for COVID-19.
Abbott said they conducted a clinical study with several leading U.S. research universities and found positive tests were 97.1% accurate and negative tests were 98.5% accurate.
"This is a really good test. It's quite sensitive, it's faster, it's cheaper, it's accessible, but it's not perfect and we need to recognize its limitations," said KSTP Health Expert Dr. Archelle Georgiou. "I do want to point out that this test is only approved for individuals that are symptomatic and the test should be done within seven days of having symptoms."
Dr. Georgiou also pointed out that this is an antigen test, not an antibody test. That means it will detect whether a person is currently infected and not whether they had the virus in the past.
On Thursday, President Donald Trump announced the federal government will buy 150 million of the tests to distribute across the country.
Abbott said they are "still working on final plans for their distribution strategy" but are preparing to ship out millions of tests in September. They said, by October, they will be able to ship out 50 million tests per month.
The tests will cost $5 each and can be performed by a variety of health care professionals, including doctors, nurses, school nurses and pharmacists.
"We need testing to be delivered at massive scale that's quick, that's reliable, that's affordable," said Andrea Wainer, Abbott's executive vice president of rapid and molecular diagnostics.
5 EYEWITNESS NEWS asked officials at the Minnesota Department of Health for their thoughts on the new test.
"There's definitely a place for these and we're glad for increasing test capacity, but there are some limitations," said Kris Ehresmann, MDH Infectious Disease director. "The challenge for providers and for us at the health department is we still have to get those results and oftentimes, the providers who use those point-of-care tests don't have the ability to electronically report laboratory information to us."
Abbott said health care providers in all settings will still be required to report positive results to the Centers for Disease Control and Prevention and other public health authorities.
The company is also rolling out a free app to be used in conjunction with the test. They said the NAVICA app will allow people to display their BinaxNOW results in places where negative tests may eventually be needed for entry, such as schools, workplaces or large events. The app will feature a QR code that can be scanned.
"A negative test result looks like a boarding pass," said Wainer. "If it's negative, they'll have a 'digital health pass.'"
Dr. Hackett added, "Antigen tests can be a powerful tool in preventing transmission and in helping America feel more confident returning to where people gather."
MDH officials were skeptical about an app being used in this manner.
"That app would be, really, in a way, meaningless because a test result is only really valid, it only tells you that you were negative, on the day you were tested," Ehresmann said. "So, for instance, if you have a test result of negative and you're three weeks out, you could easily have acquired COVID in that time and be infectious."
Dr. Georgiou added, "I think that's where we always get into the biggest problems is when we take something good and then misuse it and then have erroneous results, misinterpret the results. That's where we get into trouble so that's where we need to be careful."
Abbott did not give a timeframe for the 'digital health pass' to be used. They said it will expire "after the time period specified by organizations that accept the app."
"It's a unique app that I think will have a lot of potential as we move forward," Dr. Hackett said.
Copyright 2020 - KSTP-TV, LLC A Hubbard Broadcasting Company