We are witnessing a new era dawning in the 21st century. With the benefit of a few month’s hindsight, we can now see clearly that we were living and working under a false premise.
No longer, with impunity, can we maintain our wellbeing and be mindless to the reality that our global economy is embedded within the world’s encompassing biology. We are vulnerable creatures. We share our lives with myriad other biological entities in a swirlingly interconnected, lifegiving and at times dangerous world. The COVID-19 pandemic has brought home the truth of these realities with brutal force.
Yes, we have experienced deadly and disruptive pandemics before. Even in an average year, the Centers for Disease Control (CDC) estimates that as many as 56,000 Americans die from the flu or flu-like illness. But never before in our nation’s history have our federal and state governments placed both the healthy and the sick under a nationwide quarantine with stay-at-home orders.
By shutting down non-essential business and most social activities, many, many lives have been saved. We are truly thankful for that. But some of these quarantine measures are like swimming underwater. Sooner or later, we must come up for air.
We crave a rapid end to this lockdown. We long to gather together, without fear, with family and friends; to worship together again as communities of faith. Businesses are reeling from a dearth of customers. Those now suddenly unemployed urgently need to get back to work to support themselves and their families. Business travelers and vacationers alike wish to regain their freedom to go wherever they want, both at home and abroad. Schools and universities are staggering from the shock of closing their doors. Most students, no longer able to attend school, wish to be back again with their classmates, to learn face-to-face from their teachers, to participate in extracurricular events, and to celebrate graduation together.
Where are we to find hope during this crisis? How can we bring back these good things if we are paranoid that the very next person we meet might be infected with SARS-CoV-2, the virus that causes COVID-19 disease? Good public hygiene, contact tracing, effective drug therapies (such as the antiviral medicine remdesivir), along with herd immunity and the development of safe and widely accessible vaccines will go a long way toward fulfilling these dreams. And very importantly, medical diagnostic testing will be key in allowing us to unlock this lockdown.
I write informed by years of experience directing several testing laboratories where we analyzed samples to measure human health and environmental well-being. I write with the desire to place us all in a better position to interpret the results of millions of COVID-19 medical tests that will be run in the coming months. And I write because I wish to spark lively conversations regarding just how much medical surveillance we want intruding in our lives after the present crisis has passed.
Two kinds of medical diagnostic tests are especially relevant for the SARS-CoV-2 virus epidemic.
The first kind is the polymerase chain reaction (PCR)-based virus test. These tests look for the presence of SARS-CoV-2 genetic material in swab samples taken from the nose or throat. The second kind are serological tests. These tests look in our blood for antibodies—those Y-shaped proteins that bind to foreign substances present in our bodies—that have been specifically tailored by our immune system to attach to the SARS-CoV-2 virus and fight off the COVID-19 infection.
Of these two kinds of tests, the PCR-based virus test is the more sensitive and specific. If a good swab sample is obtained, the test results will be highly accurate. People who actually have the SARS-CoV-2 virus will be correctly identified as positive by this test. Those who don’t have the virus will be correctly identified by the test as being free of the virus.
We should bear in mind that the PCR-based virus tests are snapshots in time. They tell us, at the moment the sample was taken, if the SARS-CoV-2 virus was present. It does not tell us whether at some time in the past we had the virus. And it does not tell us whether we have become infected with the virus after the swab sample was taken.
The serological antibody test, which is simpler to run and can provide results in a matter of minutes, is not as accurate. Many people who test positive for COVID-19 antibodies will have never been exposed to the SARS-CoV-2 virus. Estimates vary, but between 10 to 30 percent of people tested will have antibodies detected by the test that are actually from a different Coronavirus infection you previously had (e.g., the common cold). This means that as tens of millions of these tests are run, millions of Americans will erroneously test positive for SARS-CoV-2 virus antibodies. Conversely, some people, especially those in the early stages of the COVID-19 disease, will test negative for the antibodies specific to the SARS-CoV-2 virus even though they have this virus and are contagious.
Health professionals estimate that 25 percent of individuals who contract the SARS-CoV-2 virus remain asymptomatic, and of those who do become symptomatic, most do not require hospitalization. So, most Americans never become likely candidates for PCR-based virus tests. The serological antibody tests, on the other hand, although less accurate are more useful for general screening purposes. They can and will provide us with a fuller picture of how widespread the virus has penetrated into the general population. These data will afford us a better understanding of how prevalent and how deadly COVID-19 is. Additionally, by broadening the population of people tested and known to have these life-saving antibodies in their blood beyond those identified by the PCR-based virus tests, more plasma can be donated and then administered as a therapy to treat patients most at risk of dying from the virus.
Here are three questions that I hope will spark others about the level of COVID-19 diagnostic testing we want and need, and who will make those decisions. As you read them, ponder whether we will feel genuinely safe and whether we can truly flourish in a world of ever-expanding, intrusive, compulsory medical surveillance?
I preface these questions with the caveat that diagnostic testing data, in and of itself, does not determine health policy, or more generally, public policy. Good policies—the choices and actions we make, informed by testing—are inherently ethical and moral decisions, not scientific ones.
Here are my three questions.
Should the health status of laboratory and health workers around the world who are regularly exposed to viruses capable of causing pandemics be screened on a daily basis?
It takes months and even years to develop accurate diagnostic tests and safe and effective vaccines. Should development of diagnostic tests and the vaccines themselves be done concurrently with research being conducted at Biosafety Level (BSL)-3 and BSL-4 facilities that handle highly dangerous and exotic microbes (like the one I once visited on the NIH campus in Bethesda, Maryland)?
Will we, the general public, become subjected in the future to routine screening for infectious diseases—like TSA workers now screen boarding passengers at airports—before we are allowed to return to work or even venture out in public?
Every choice we make will have attendant risks. I mean no disrespect and I am deeply grateful for the tireless work they are doing. But the policies we adopt should not be decided primarily by unelected health professionals and those working in the burgeoning medical-industrial complex. We cannot abdicate our responsibility and simply defer these decisions to the experts. Working together as a democratic society, guided by a coherent and comprehensive framework of science, ethics, and aesthetics, we the people must take an active and prominent role in making these tough decisions for ourselves.
On Thursday, May 14, 2020, Virginia announced that antibody tests conducted within the Commonwealth will no longer be included in their daily tallies of coronavirus tests. Owing to the less reliable performance of these serological test compared with the genetic tests conducted on swab samples from the nose, these antibody tests are not used by Virginia to confirm cases of COVID-19.
Since I wrote this article, The Centers for Disease Control and Prevention (CDC) has released “Interim Guidelines for COVID-19 Antibody Testing.” In this informative document they write “For example, in a population where the prevalence [of COVID-19] is 5%, a test with 90% sensitivity and 95% specificity will yield a positive predictive value of 49%. In other words, less than half of those testing positive will truly have antibodies.”
In commenting on these Guidelines, CNN medical and science Senior Editor Maggie Fox wrote an article titled “Antibody tests for Covid-19 wrong up to half the time, CDC says.” In her article she wrote “If just 5% of the population being tested has the virus, a test with more than 90% accuracy can still miss half the cases.” (see http://www.cnn.com/2020/05/26/health/antibody-tests-cdc-coronavirus-wrong/index.html).
While I am pleased she is bringing this issue to the attention of the public, she is wrong in her analysis. She has got it 180 degrees backwards. The CDC is saying that in this realistic antibody testing scenario, an antibody test is wrong more than half the time NOT because it missed half the cases, but because it erroneously finds way too many cases! In fact, more than half the people tested who are told they have antibodies truly do not have antibodies to the SARS-CoV-2 virus that causes COVID-19.
I am gratified that CDC interim guidelines now are confirming what I wrote in this article “This means that as tens of millions of these tests are run, millions of Americans will erroneously test positive for SARS-CoV-2 virus antibodies.”
Joel Achenbach, who covers science and politics for the Washington Post, recently wrote a column titled “‘Tell me what to do! Please!’: Even experts struggle with coronavirus unknowns.”
In the article he quotes Brian Nosek, U-Va. Psychology Professor and Co-founder and Executive Director of the non-profit Center for Open Science who said “We all want answers today, and science is not going to give them. … Science is uncertainty. And the pace of uncertainty reduction in science is way slower than the pace of a pandemic.”
I wish Joel would take Professor Nosek’s words to heart.
I do agree with Joel when he writes “Not only do experiments take time to devise, execute and analyze but the broader scientific community usually has a chance to scrutinize and potentially falsify the results. This process has been largely abandoned during the pandemic.”
Where I strongly disagree with Joel is when he states unequivocally that the pandemic “… is a natural event — zoonosis, the transmission of a disease from an animal to a human — made more common by the burgeoning human population, exploitation and illegal trafficking of wildlife, and the globalization of commerce that has turned the planet into a mixing bowl.”
Science does NOT know that the COVID-19 pandemic arose from a natural event! It may just as well have originated from a release of the virus from a research laboratory.
First, the actual SARS-CoV-2 virus that infected the first human in Wuhan China has never been identified in any animal in the wild.
Second, and intriguingly, current scientific research such as the vaccine work of Flinders’ University Professor Nikolai Petrovsky.shows that SARS-CoV-2 binds to receptors in human cells more strongly than the cells of other animals. “This virus is amazingly adapted to humans, and that’s not normal in a situation where a virus has come from a wild animal to a human. This virus was clearly perfectly adapted to humans from day one.” says Professor Petrovsky.
The possibility of a laboratory origin of SARS-CoV-2 virus should not be precluded out-of-hand by the Washington Post or by anyone else.
And this very real possibility of a human origin is why I asked the question in my article “Should development of diagnostic tests and the vaccines themselves be done concurrently with research being conducted at Biosafety Level (BSL)-3 and BSL-4 facilities that handle highly dangerous and exotic microbes (like the one I once visited on the NIH campus in Bethesda, Maryland)?
If we want to reduce the risk of viral pandemics in the future, we must let scientific facts help us understand how this one got started in the first place.
Dr. Gao Fu, Director of China’s Center for Disease Control and Prevention, recently reported that he had “assumed the seafood market might have the virus, but now the market is more like a victim.” So after having informed the world that the SARS-CoV-2 virus likely originated from wild animals sold in Wuhan, Dr. Gao now is reporting that Chinese scientists have never found the SARS-CoV-2 virus in any of the animal samples they obtained from the market.
Additionally, the theory that the SARS-CoV-2 virus that causes COVID-19 recently jumped from bats is looking less likely. I quote from an article posted online at http://www.dailymail.co.uk/news/article-8373007/Beijing-admits-coronavirus-DIDNT-start-Wuhans-market-DID-come-from.html
“Prof Zhang also noted the viruses closest to the new one were sampled from bats in Yunnan, 1,000 miles from Wuhan. Although 96 per cent genetically similar, ‘in reality this likely represents more than 20 years of sequence evolution’.”