A Missing Elements… Insight: The way to a post-COVID US is ending public COVID self-testing.

The first half of environmental health scientist James L. Sherley’s new book, Missing Elements in the Public Science Supporting the COVID-19 Spread Narrative in the US, ends with Chapter VI, “The new epidemiology of COVID: The plague of testing.” This organization places the central concern of Missing Elements…, which is the lack of attention given to false-positive COVID test rates, at the heart of the book. This concern is complex, with much associated scientific criticism and social angst. As the US COVID crisis seeks a sustainable equilibrium, the civil liberties of many Americans are now under continuing assault by erratic requirements for COVID testing and vaccination insisted upon by restaurants, museums, stores, institutions, and even by many people’s families and friends before they are allowed to attend family and social gatherings. Each establishment, organization, or person levying such a tax on others feels authorized to do so by the now mostly defunct local and federal government mandates, which are largely the origin and basis for their COVID beliefs and discriminatory COVID practices.

As people go about their usual business, grocery buying, entertainment, and dining, they are surrounded by now worn-out and fading ghosts of 6-foot spacing tape, social distancing signs, and posted masking instructions at entry doors. Sanitizer pump bottles at entrances now sometimes have dried closed nozzles due to their usage being reduced to only the most fastidious COVID fighters. Many people are maskless because the mandates are gone, whether or not they have been vaccinated or boosted up to government-recommended compliance. However, this seemingly safe, post-vaccine COVID world is contradicted and contraindicated daily by erratic demands for vaccination or COVID testing in order to be allowed entry into public establishments, as well as private homes. In this post-vaccine COVID world, the US government has gone from excessively restrictive, discriminatory COVID mandates to abandonment of much of its responsibility, leaving Americans to figure out post-vaccines COVID practices for themselves and others.

Americans might have had a chance at sorting out the best COVID practices on their own, if it were not for the US government’s ill-advised decision to flood the nation with poorly-performing tests for evaluating COVID status. The current widespread use of rapid COVID antigen tests is a major impediment to the US getting to a post-COVID world. Missing Elements… exposes the misleading and detrimental consequences of under-studied and under-reported false-positive COVID test rates, beginning with the earliest introduction of PCR testing to the current rapid antigen tests. As discussed in the book, even the expectations for the savior COVID vaccines were undermined by the use of PCR tests to diagnose COVID illness without accounting for the false-positive rate of the tests.

The remarkable thing about the introduction of rapid antigen testing is that the government and media now acknowledge that these tests have a high false-positive rate. Though published scientific analyses are still limited in number, those that have been reported indicate disturbingly high false-positive rates. Two studies from Canadian research teams published in November 2021 and February 2022 report positive predictive values (PPV) ranging from 23% to 70%, and, as early as January 2021, the US CDC posted a college campus study that determined a PPV of 33%. The lower the PPV, the poorer the performance of a test. The PPV is the percentage of positive results given by a test that are actually correct. Subtracting the PPV from 100% tells us how often a test is wrong when it indicates that someone has COVID antigen in their body. Even these reported estimates must be viewed with care, because the basis for establishing the “true positive” results for comparison in these studies was a secondary PCR COVID test. The proper estimate of the PPV of rapid antigen tests is the PPV of the rapid test corrected by multiplication with the PPV of the PCR test used. None of the studies reported so far indicate this correction, which would give an even lower PPV estimate.

Even the highest reported PPV estimate of 70% is not acceptable for how rapid antigen testing is currently being used in the US. This PPV means that 30% of the time when someone has a positive rapid antigen test, the information they receive is false. Based on the currently available scientific analysis reports, a more conservative estimate of the PPV of rapid antigen tests is likely to be about 50%, meaning that, on average, about half of the positive results with these tests are falsely misleading people into thinking “they have COVID,” when it is equally likely that they do not.

The significant consequences and costs caused by this irrational post-vaccine COVID practice are readily seen in the current distress endured by US citizens returning from abroad by air. The US government requires that entering airplane passengers had a negative COVID test 24 hours before their flight, or they must quarantine for 10 days before returning. Statistics.com reports that 44.8 million Americans traveled abroad and returned by airflight in 2019. In 2020, COVID reduced this number to 9.8 million. With the current recovery during post-vaccine COVID, the number of returning American airplane passengers will be at least 10 million or more this year. Many Americans are carrying and using rapid antigen tests to determine their COVID status. A very modest rapid antigen positive test rate of 0.05% equates to 5000 returning Americans obtaining a positive test result. A PPV of 50% means that this year about half (2500) of these Americans will needlessly incur the distress and cost of an unplanned 10-day stay in a foreign country, the cost of rescheduling air travel, and, as well, the disruptive consequences of an unexpected delayed return to their homes, work, and life.

The described greatly upsetting scenario is now being played out in real time, and many similar ones are also occurring in many places beyond foreign airports, right here on US soil, in our colleges, entertainment venues, schools, public establishments, neighborhoods, and homes. However, such disruption and heartache are entirely preventable by simply ceasing all mandates and entry requirements based on COVID testing. The performance of rapid antigen tests for identifying individuals who are COVID antigen-negative is somewhat better than that for identifying positive individuals, making errors only about 20% of the time. However, much of this better performance is a mathematical corollary from many more people being negative for COVID anyway. There is no sound scientific, medical, or public health justification for unleashing such a dangerously defective COVID crystal ball into the hands of the American public. In fact, this government policy verges on being criminal. There is no question that it has been, and continues to be, harmful to the country and is a major untethered policy and practice standing in the way of getting to a post-COVID America.

A “[f]alse sense of security” captures the respective problem and justification of current rapid COVID antigen testing in the US. As charged in Chapter X of Missing Elements…,

“…in reality, free antigen tests are just the latest device used by the current US government administration as a strategy to appease complaints that they are not doing enough to stop COVID in the US. Their solution, based on political expediency, has only further aggravated the crisis for the US people.”

Understandably and forgivable, many Americans using rapid antigen tests are looking for the security of an indicator that they and their families are safe. Some may even have more magnanimous motivations to make the nation safer on the whole for everyone. Unfortunately, if the basis for that safety is essentially flipping a coin, as the 50% PPV of rapid antigen tests indicates, it becomes more dangerous than safe. In the current post-vaccine COVID world, such a false sense of security also becomes harmful and injurious to others, whose liberties are pushed aside by those wielding the authorization of the test, which they believe to be meaningful, when, in reality, it is often misinforming and misleading.

Improving the performance of rapid antigen tests, if it were even possible, is not the answer to the current confounded disarray of US COVID public policy. The answer is restricting all COVID testing to only scientific and medical applications. Chapter VI of Missing Elements… warns against the continuing wages of widespread COVID self-testing by the general US population. People do not need a test to know if they are not feeling well. They need an accessible primary care system that has the best tools available for diagnosing and treating their illness. Medical professionals are better trained and prepared to evaluate critically the significance of clinical test results, whether the tests have superior or poor performance. If the US government can find the will and the means to reel back in public COVID self-testing and return to well-established best practices for disease diagnosis and treatment, the US may finally achieve a post-COVID world.

Dr James L. Sherley, is a physician scientist and bioentrepreneur who currently serves as the President and CEO of stem cell biotechnology company Asymmetrex, LLC. He holds joint MD and PhD degrees in Medicine and Cellular and Molecular Biology and Genetics. His graduate research was conducted in a molecular virology laboratory. Before starting his professional career in biomedical research, he trained as a Postdoctoral Fellow at Princeton University, with cancer cell molecular biology as the area of specification. In 1998, Dr Sherley moved to a faculty appointment at Massachusetts Institute of Technology in Cambridge, MA, before working as a Senior Scientist at the Boston Biomedical Research Institute. Throughout his professional career, Dr Sherley has served on numerous scientific advisory boards, including serving as the Chair for the Meharry-Vanderbilt National Institutes of Health U54 Cancer Health Disparities Partnership Program Steering Committee and as a member of the National Institute of Environmental Health Sciences National Toxicology Program Board of Scientific Counselors. He also actively contributes scholarly articles on bioethics issues in science, medicine, and society.

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