The Dangers of Growing False Negative Rates

How shortfalls of the current COVID test market affect us personally and globally

April 15, 2022

On January 8th, 2021 the FDA Released a Statement that “false negative results may occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’ genome assessed by that test.” Furthermore, a study done by the University of Oxford and Public Health England’s Porton Down laboratory showed that Nasopharyngeal swab test’s sensitivity fell to about 58% when administered by self-trained test center employees, versus 73% when tested by skilled NIHR research nurses and 79% when tested
by Porton Down laboratory scientists. You can find links below to read the original articles.

What does this mean for us and the world?

If someone takes a COVID Test and receives a False Negative result, they are far more likely to unintentionally spread the virus both by diminishing the importance of proper mask wearing and hand washing, and by choosing not to quarantine. This becomes even more likely in asymptomatic cases. This spreads the virus in our communities which in turn increases hospitalizations and deaths due to COVID-19.

Michelle is one such person who fell victim to a false negative result. She is a first time mother to a baby born in 2021, so she had taken great care to ensure her baby’s safety from the virus. In December, some of her extended family members had gotten sick but also had suffered a very difficult family situation. Two of the family members had tested twice each for COVID, both times getting a negative result, so Michelle and the rest of her family decided they were willing to endure a little cold to provide comfort for their loved ones. Fast forward a few days and worsening symptoms prompted another COVID test, this time from a trained physician, which finally showed that they all were infected with the virus. Watching her baby suffer while she and her husband were sick themselves was not an easy task and she looks back on her decision with regret, “While I am glad we could be there for our family, had I known they had COVID I would not have gone there and put my 7-month old in harms way.”

Sydney also was impacted by a false negative. She and her husband, had decided to spend time during the holidays with her family even though they were a little sick because they had tested negative for COVID. After Christmas, they flew to Texas to spend time with his side of the family only to receive a call that they were infected as well. After travelling all that way, they were unable to see his elderly grandparents for fear of endangering them.

As the virus has evolved and at-home tests have become more widely used, the higher instance of false negatives is likely causing the virus to spread even faster because of the false confidence it provides.

Thankfully there will soon be a solution.

Dr. Anne Wyllie, Principal Investigator at SalivaDirect™ and a research scientist in epidemiology at Yale School of Public Health found out in April 2020 that saliva worked just as well as if not better than nasopharyngeal testing for SARS-CoV-2 detection.

After many many months of research, development, clinical trials, logistics, etc. Clear Health Pass® in collaboration with SalivaDirect™ is soon launching a new Covid-19 Multi-Variant ID Lollipop Test ™. A game-changing saliva test that will have very high accuracy levels based upon initial clinical data and research.

We are so excited to soon provide the public with an at-home, fast, non-invasive, affordable way to accurately and reliably determine their infection status. Our intention is that this will give us all the confidence and peace of mind we deserve.

Find out more at www.clearhealthpass.com

To read the FDA Statement, please click HERE

To read the BMJ Article containing the Oxford/Porton Down Lab Study, please click HERE.

*Names have been changed for privacy