It’s an approved test — why do they keep testing it?
By Mike Blaivas, MD, MBA, FACEP, FAIUM, Chief Medical Officer
Why would somebody need to keep testing a test designed to detect Covid-19 infection? It either worked or it didn’t when the FDA approved it and hopefully, they did not approve a test that does not detect the virus…
This should be the question that would automatically enter most people’s minds. However, the answer is actually quite interesting and maybe concerning. Many of us have had the experience of taking a Flu test over the years and assume it just works, so why would things be different with Covid-19? Without going into the updates required for Flu tests too much, things are somewhat different with Covid-19. This crazy virus has had many different variants, some that are horrible and some that are much less bad.
If you have ever read the news about an upcoming Flu season that was expected to be bad, you heard something about scientists trying to predict what Flu variants to include in the Flu vaccine months before it is ever given. The key is there are many different versions of the Flu virus and if you don’t pick the right 3 or 4 to immunize people against you could completely leave vulnerable people defenseless against the upcoming Flu infection wave.
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The problem with Covid-19 detection is somewhat similar when it comes to testing. There are many different variants with new ones arising all the time. Some tests could lose their ability to detect the virus if there is enough of a mutation in a new variant. This is especially a problem for some of the antigen-based rapid tests. One change in the spike protein has made such tests useless and the FDA has had to pull several off the market since the pandemic first started. Test failure through variant mutation is less likely for molecular tests, but the risk is not zero and vigilance is needed with regular testing of new variants against existing tests.
So, who cares if a new variant is missed for a while on some tests? You may if you or a loved one gets sick. I recall an emergency department shift in the early months of the pandemic when we ran out of PCR tests (with only send-out available) and had to use antigen tests in the emergency department. I tested 7 patients with antigen tests suspected of Covid based on their lung ultrasound examinations. Four were negative for Covid and were admitted to a Covid “negative” hospital floor. The other 3 were positive for Covid, so I started treatment and admitted them on the Covid “positive” hospital floor. Three days later, we found out all 4 of the negative antigen tests were actually wrong, confirmed by the send-out PCR tests. All 4 got sicker and infected other vulnerable patients on the Covid “negative” floor. Now, imagine a new strain comes up and it is very severe; however, it’s not detected by some tests because of the new mutations. Then, sick people test negative leading to missing out on timely Covid-19 therapy which may not work as well later in the disease. That could cost lives at the worst and allow other patients to get much sicker than necessary.
Ideally, healthcare providers have access to affordable, rapid, point-of-care molecular tests to make quick treatment decisions. Anavasi Diagnostics manufactures The AscencioDx® Molecular Detector and COVID-19 Test. This platform provides positive test results in as little as 20 minutes and is regularly quality tested against the latest emerging genotyped SARS-CoV-2 variants tracked in the GSAID/ROSALIND database. To date, it continues to provide 99.99% coverage. As of this article, these variants also include the most recent detected in the US - Eris (EG.5), Fornax (FL.1.5.1) and the newest, Pirola (BA.2.86). This product is FDA EUA cleared as a CLIA-waived test for use in point-of-care settings.
For further information contact sales@anavasidx.com or visit our website www.anavasidx.com.
Where Speed, Efficiency, & Accuracy Align
The AscencioDx® Covid-19 Test and The AscencioDx® Molecular Detector have not been FDA cleared or approved, but have been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
