By Larry Quick
One in a series
As a life-long Chicago Bears’ fan I keep an eye on our Division rivals. So, I was interested when the media reported that Matthew Stafford, the quarterback for the Detroit Lions, tested positive for COVID-19. Then he tested negative, and negative again. Finally, it was determined that he had a false positive and that Stafford never had Coronavirus. The pundits asked how it could happen. Someone even asked how the National Football League (NFL) knew the negative results weren’t false negatives. It was a mess for Stafford. However, what really surprised me was his wife’s Instagram post which gave details of the nightmare it caused for their family:
“Even after we knew it was a false positive, the school told us they were not allowed back, I was approached in a grocery store and told I was “endangering others”, my kids were harassed and kicked off a playground, I was told I needed to wait in my car when trying to pick up food, and people closest to us had to get tested just so they could go back to work….”
So, I have to ask, what are these tests that are causing such an impact on our lives? These tests determine what businesses can stay open, if your children can go to school, whether or not you will be quarantined.
Although we constantly hear about how many tests are conducted and how fast we can get the results, little has been written how the SARs virus is detected or the accuracy of these tests.
The Food and Drug Administration (FDA) is required to evaluate whether medical devices and products have been shown to be safe and effective. Americans rely on the FDA’s assessment for their safety. However, in certain emergencies, the FDA can issue an Emergency Use Authorization (EUA) for medical products when there are no available options. The FDA is required to weigh the risks and benefits of the unproven products.
Due to the current pandemic, in February 2020 the Secretary of HHS (Health and Human Services) declared that circumstances exist, to justify the authorization of emergency use of in vitro diagnostics, for the detection and/or diagnosis of COVID-19. In other words, all SARs CoV-2 diagnostic tests have not been officially approved by rigorous FDA assessment methods, but are being used under the EUA. Currently, the FDA requires only “minimum testing to be performed to ensure analytical and clinical validity for COVID-19”. To date, the FDA has authorized 101 molecular tests (positive/negative COVID-19) under EUAs.
The results of these tests have an enormous influence on our daily lives. In my next article, I will outline the science behind these tests, and explain how the technology upon which they depend, was not designed as a tool for diagnosing disease.
Second part is available at thevoice.us/covid-19-positive-tests-meaning