Rapid Antigen Test for Coronavirus – So there has been some big news when it comes to coronavirus testing. Recently, Abbott Laboratories came out with a new rapid antigen test called BinaxNOW COVID-19 Ag Card, and it got emergency approval from the Food and Drug Administration (FDA). An Emergency use authorization by the FDA is permission given to unapproved products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening conditions.

Link to FDA website for this test:
https://www.fda.gov/news-events/press-announcements/covid-19-update-fda-authorizes-first-diagnostic-test-where-results-can-be-read-directly-testing-card

The test costs $5 and detects COVID-19 infection in 15 minutes. This new BinaxNOW rapid antigen test made by Abbott Laboratories uses a nasal swab in the same manner as a rapid flu test. Unlike most of the other nasal swabs used to COVID Test, this one doesn’t have to be jammed all the way up in the nose. According to Abbott, and this is listed on the FDA’s website, the test has demonstrated 97.1% sensitivity and 98.5% specificity. These tests are compared to samples that tested positive with the PCR method, and they then compare the results.

Also, I should mention that the NIH does independent tests to verify the accuracy of the coronavirus tests because its hard to trust a company’s own numbers. But these are the numbers that the company is claiming, and so far there aren’t independent tests that have been done. The FDA said in a statement that negative results with Abbott’s test may need to be confirmed with a lab test in some cases. For example, if there is a high suspicion that someone has COVID based on their symptoms or exposure.

Rapid Antigen Test for Coronavirus

Also, I should add, that even if a test is perfect, let’s say in theory its 100% sensitive and 100% specific, it’s still possible to get a false negative – not because of the test itself. Sometimes its due to the way the test is conducted, meaning poor technique is used. Sometimes, when it comes to coronavirus – some people can have the coronavirus in their lungs, without necessarily having it in their nose. This was actually proven, and I did a video on this, in a study of patients who died of coronavirus. 9 out of the 12 patients had the virus in their lungs but not their nose, and they used PCR testing for this. So that’s something else to keep in mind.

Another aspect of this BinaxNOW test is that it will come with a free mobile app called NOVICA, which will allow users that test negative to display their results as a “digital health pass,” This digital health pass would serve as a temporary, date-stamped result that is renewed each time a new test is taken. With the typical PCR tests that are done, meaning the ones that are lab-based, you get excellent sensitivity but they take time, a least a few hours or longer to get results. Since the start of the pandemic, nasal swab tests that are sent to a lab have been the standard for COVID-19 screening.

While these PCR tests are considered the most accurate, they take at minimum a few hours before you get results. They’re also expensive and require specialized machines and chemical reagents, and shortages of these supplies have led to delays in getting results. But with this new antigen test, we can quickly identify COVID infections and get them into quarantine. Plus, it’s cheap, and is being massed produced…Abbott says that starting October they will ship 50 million tests a month. And following this announcement, the government said they will be purchasing 150 million of these tests from the company.

This will allow for massive testing, moving one step closer to getting this pandemic under control, especially when it comes to getting schools and businesses reopened, and especially with the fall and winter coming, which means cold and flu season. And with such an overlap of symptoms between the common cold, flu, and COVID, this massive scale rapid testing will be all the more important. With this test, along with the other 3 FDA approved rapid antigen tests, they can’t be done at home, as they’re only allowed to be given by healthcare professionals. So basically, doctor’s offices, emergency rooms, urgent care centers, pharmacies, drive-thrus, and some schools.

Dr. Mike Hansen, MD
Internal Medicine | Pulmonary Disease | Critical Care Medicine

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