The response to the COVID-19 pandemic has created a public health and economic crisis leading to psychological suffering and economic pain for billions of people across our green and blue planet.
Mass Population Testing is the Key To Stopping the Spread of COVID-19 Disease
The key to stopping the spread of the SARS-CoV-2 virus – the cause of the COVID-19 disease in humans – is mass surveillance: identifying all of those who are contagious and quarantining them until they are no longer contagious.[1]
The motto is: test for the virus, isolate infected individuals, repeat.
Testing is the key to stopping the spread of the virus until an anti-viral drug and vaccine is invented (see the StatNews Covid-19 Drugs and Vaccines Tracker).
The problem is that most countries are not doing complete population testing (Taiwan and South Korea with their targeted testing, isolation, and contact tracing for the most part are). That is, they are not testing everybody. COVID-19 testing has been limited to a selective portion of a country’s population at any given time, leaving the vast majority of individuals at any given time untested.
The result of this selective testing, according to one study, published in Science Translational Medicine, is that an estimated 8 out of 10 individuals who were infected with the SARS-CoV-2 virus, were undiagnosed “across the United States during the 3-week period from 8 to 28 March 2020.” According to the study authors:
“Detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections to date has relied heavily on reverse transcription polymerase chain reaction [PCR] testing. However, limited test availability, high false-negative rates, and the existence of asymptomatic or subclinical infections have resulted in an undercounting of the true prevalence of SARS-CoV-2.…Together, these results suggest a conceptual model for the COVID-19 epidemic in the United States characterized by rapid spread across the United States with more than 80% infected individuals remaining undetected.” [2] [emphasis added]
Observes one of the study’s authors:
“In a dream world, everyone who comes in would have a test. We would be able to get a full scope of the pandemic.”[3]
A dream world indeed.
To further compound matters, many of those undiagnosed individuals infected with the COVID-19 virus who are contagious show no symptoms (are asymptomatic). Unaware of their state, they end up infecting other individuals. In other cases, they only show symptoms after they have already spread the virus, so when they are tested, it is too late.
When too many individuals get infected, and hospital resources are overwhelmed, the government’s response has been social and economic lockdowns to limit the spread of the virus. Only after the number of infections drops to manageable numbers does the government end the lockdowns, and then the entire process repeats as the government fails to test enough individuals.
So instead of test, isolate, repeat, we have a failure to identify those infected from not testing everybody, leading to the failure to isolate everyone infected with the COVID-19 virus, leading to the further spread of the virus. In response, many governments have copied the Communist China model of mass lockdowns (quarantines with a severe restriction of the freedom to move and associate of the infected and non-infected people) as the solution to ease the burden on highly government-regulated or government-owned hospital and healthcare systems. Such draconian lockdowns that hold the individual guilty of being infected until proven otherwise are a clear violation of individual rights (see Ghate: A Pro-Freedom Approach to Infectious Disease).
Why don’t nations engage in systematic population testing as selective testing alternating with lockdowns doesn’t work? One reason is the test mandated by government health agencies: the Polymerase chain reaction (PCR). [4]
PCR tests, though highly accurate, are not suited for mass nation-wide COVID-19 testing
The PCR (Polymerase chain reaction) test is known as the “gold standard” of testing as it can detect SARS-CoV-2 particles in microscopic amounts. Its chief virtue is its “high sensitivity” in detecting virus particles: a PCR test can usually detect a single molecule of RNA in a microlitre of solution. It can detect virus genetic material long after a person has had the virus and is no longer infectious.
The PCR test is also useful for specific situations – such as if someone who died has minute virus particles, but, for real-world mass-screening, PCR tests are a failure.
The reason why PCR tests fail for mass nation-wide testing is fourfold:
1. Speed of reporting: PCR tests do not give immediate results.
One of the problems with PCR tests is that it can take a long time to get results: from a day to weeks.[5] Reports the New York Times on the genius and the torment of PCR testing:
“The virus’s genes must be extracted from the sample with a specific suite of chemicals. The material is then processed through a laboratory technique called polymerase chain reaction, or PCR, in which a machine cycles through several temperature changes to amplify genetic material. This step is key to these tests’ success: Copying genetic material over and over means that even tiny amounts of the virus can be spotted.”
“But the process can bog down at multiple points. Swabs and chemicals necessary for processing are often in short supply, and invasive sampling requires trained health care workers who quickly drain precious supplies of gowns, gloves and masks. Additionally, many community testing centers lack PCR machines and must outsource their samples to large laboratories, leading to delays of days or even weeks.”
“Rachel Coker, the director of research advancement at Binghamton University — one of many institutions nationwide that have begun to reopen — had to wait 10 days for her results after being sampled at a drive-through testing site.” [Emphasis added] [6]
And when there is a virus surge, there can be a considerable backlog in getting test results. Again, quoting another article in the Times:
“Mr. Adler, a Democrat, said the testing crunch was the result of the demand for tests statewide, brought on by the uptick in coronavirus cases after Texas reopened in fast-moving phases starting on May 1. He attributed the problem in large part to a backlog at laboratories; in some cases, test results take four to six days, far longer than the 24 hours health experts recommend to most effectively isolate the ill and track people they have had contact with.” [7]
Such a delay in reporting results means that if a person is contagious, they won’t know until it is too late, and they have spread the virus (unless they are quarantined until test results are available). If only there were a COVID-19 test that can give results immediately like a home pregnancy test.
2. Ease of use: PCR tests require specialized personnel and are not easy to administer at home or work.
PCR tests require specialized and expensive lab equipment that requires specially trained personnel to both administer and interpret the test. This limitation prevents the general population from taking the PCR test on their own. It prevents people from taking a test when they wake up in the morning, before they board a plane, or before they check in to work or school.
If only there were a COVID-19 test that someone could easily do on their own, and that gives immediate results like checking one’s temperature with a thermometer.
3. Cost: PCR tests are expensive.
The need for specialized lab personnel and equipment makes PCR tests expensive. Tests can range from $100 to $300 per test, and those test results are only valid for the time the test was taken, i.e., if you were exposed to COVID-19 after the test, your money is wasted. So taking PCR tests frequently, on a daily basis, becomes prohibitively expensive. If only there were a COVID-19 test that was inexpensive, easy to use, and that could give results quickly.
4. Frequency of testing: PCR tests are not scalable.
When many tests are done at once, labs get flooded, and the back-log in receiving test results can take weeks. To prevent such flooding, many governments have created rules to ration and prioritize testing: such as limiting testing to those who show symptoms, etc. Given the costs and resources required, it is impossible to test everyone simultaneously via PCR tests. If only there were a COVID-19 test that is inexpensive, easy to use, gives results quickly, and is scalable so everyone could be tested frequently and at the same time.
In summary, PCR is a useful tool in the fight against the COVID-19 virus because it is highly sensitive to minute amounts of virus particles, even in those not contagious. But, for mass scale, easy to use, affordable, rapid-response testing, to identify those who are contagious, PCR fails. PCR tests for screening purposes are like using a bulldozer to dig a one-foot hole when a simple, cheap shovel will do.
The solution to lockdowns: a cheap, rapid response, easy to use COVID-19 screening test that is as simple to use as a home pregnancy test
What is needed for proper COVID-19 surveillance is a test that is easy to administer, like a home pregnancy test. For mass surveillance purposes, such a test should be sensitive enough to detect when people have a high viral load — when they are most contagious. It should be affordable enough to be used frequently, i.e., daily. It needs to give immediate results like a thermometer. It should be a test that everyone can use and interpret for its purpose.
If only such a test existed.
What I have described sounds like a miracle, doesn’t it? Except that it is not a miracle. Multiple companies – including 3M, E25Bio, Sherlock, and Abbott – have developed such COVID-19 antigen tests, and they work perfectly for screening purposes. They can manufacture them quickly in the billions, and their retail cost is $1 per strip test. These tests have been available since March 2020.[8]
Where the PCR tests look for viral particles and antibody tests look for antibodies in those who have recovered from the virus, antigen tests look for antigens your immune system creates to detect and respond to a COVID-19 infection. Where PCR tests identify whether you have minute COVID RNA in your system, and antibody tests are useful in detecting if you are immune, antigen tests are well suited to screening those who have high amounts of antigens when they are most contagious. They are different tools for different purposes.[9]
Like a home pregnancy strip, $1 home antigen tests are not as accurate as a $300 lab test, but they are more than good enough to catch most cases when used frequently.[10]
They can be easily used, at home or work, and don’t require a blood test, but only require a nasal or saliva sample. They may not be useful for situations where 100% accuracy is required, but given their scalability for mass use that PCR tests lack, they are the best option as a home and work screening tool. Such tests are not a replacement for PCR tests, but they have an important purpose: screening and catching people who otherwise would go untested.
Research shows that frequent, rapid-result SARS-CoV-2 testing is more important than “gold standard” accuracy in slowing the spread of the COVID-19 virus
One of the most prolific of the scientific advocates for these screening tests is Dr. Michael Mina from the Harvard T.H Chan School of Public Health.
According to Dr. Mina, these cheap, at-home, antigen COVID-19 tests can slow the spread of the COVID-19 virus dramatically. Medina’s research (along with a group of other scientists) has shown that the sensitivity of daily-use test strips, though not as sensitive as PCR tests, are good enough to detect the vast majority of those infected with COVID-19. Their “results demonstrate that effective surveillance, including time to first detection and outbreak control, depends largely on frequency of testing and the speed of reporting, and is only marginally improved by high test sensitivity. We therefore conclude that surveillance should prioritize accessibility, frequency, and sample-to-answer time; analytical limits of detection should be secondary.” [11]
(For those interested in the interaction between viral load, test frequency, and sample to answer delays take a look at the COVID-19 Testing Group’s surveillance policy calculator.)
A 50% detection home test is better than having no (0%) detection test at all
So why aren’t these inexpensive test strips available to the general public for screening purposes? Because central government planners are using the police power of the state to prevent $1 test strip producers from selling them, i.e., the FDA/CDC has not approved them.
Comments Dr. Mina on this disastrous regulatory problem in a USA Today interview:
“I’m usually not against regulation, but it’s just gotten so extreme here, and it’s truly been hindering every step of the way our ability to test our way out of this virus since February. The current landscape is bottlenecking these companies that could have a cheap test today into producing a more expensive espresso machine, because they can’t actually legally use the instant coffee.”
“Until the regulatory landscape changes, these companies have no reason to try to bring (a fast, cheap, at-home test) to market. So, a lot of them are just kind of sitting on it. Or they’re trying to spend more time and more money to better and better optimize tests, which might take months. My fear is that what will come out of it at the end of those months is a test that does meet FDA approval, but that’s too expensive and too complicated to scale and use for everyone.” [12]
Why haven’t they approved them? The argument made is that these tests don’t meet FDA/CDC requirements for sensitivity: which is that such over the counter (OTC) tests must be 90% sensitive.[13] Why must all tests be that sensitive given that screening is “marginally improved by high test sensitivity“? Because the government planners say so.
The government regulator’s argument against lower sensitivity tests completely misses the point. A home test with low sensitivity is better than no home test. Even if the test only catches 50% of the people not caught before, it is an improvement over no test. Most masks are not 100% protection from COVID-19, but does the government ban their use? Of course not. We don’t ban masks because they are not 100% protective, and neither should the government ban screening tests that are not 100% detective.
| PCR Test | Antigen Test | |
| Tests for | Viral Particles | Antigen to Viral Particles |
| Frequency of Use | Low | High |
| Requires Lab | Yes | No |
| Cost | $100 – $250 | $1 – $5 |
| 100% Scalability | No | Yes |
| Ease of Use | Processed in Lab | Home or Work |
| Sample To Answer Time | 1-7 days | 10-15 minutes |
| Sensitivity | Gold Standard | 70% to 90% |
Though antigen tests are not as sensitive as PCR for detecting those with very low viral loads leading at times to a false negative (failing to catch someone infected), antigen tests do relatively better at detecting people when they have a high viral load and are most contagious – in a timely manner.
Right now, the best people can do at home is take their temperature with a thermometer – which essentially is no test at all. Presently, individuals are only tested for COVID-19 when they show symptoms or have been in close contact with confirmed cases or to meet other government regulated requirements. That leaves the vast majority of people who are infected and contagious but not experiencing symptoms, unaware of their infected state.
So from a practical point of view, the FDA’s use of police powers to block the sale of such cheap, screening tests is unwarranted. In cases where greater accuracy is required, people can still opt for a PCR test: the two – antigen test strips and PCR tests – are not mutually exclusive alternatives.
Low Cost $5 Antigen Tests with Over 90% Sensitivity are FDA Approved, But Not For Personal Use
This August, the U.S. government approved a $5 COVID-19 antigen card test, the BinaxNOW™ COVID-19 Ag Card rapid test, which they claim is over 90% sensitive.
According to Abbot Labs:
“The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results.”
Abbot states that the “Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset” in their testing.[14]
The company expects to produce at least 50 million test kits a month:
“Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.”
Unfortunately, the government dictated that one needs a prescription for its use and that it can only be used by those who have symptoms:
“Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use [only] by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.”
Much as the government restricted the sale of masks, the government restricts the sale of cheap, easy-to-use testing kits to home and work consumers.
“Abbott’s BinaxNOW™ COVID-19 Ag Card is highly portable, about the size of a credit card, and doesn’t require added equipment.”
That the government mandates that only “healthcare professionals” can administer the test and that it requires a “patient prescription” makes no sense. It makes a $5 test into a $5 test plus the cost of a prescription. Neither does it make sense to prohibit testing for those without symptoms. Such laws effectively outlaw mass-scale in-home or at work screening, unless you wish to keep a doctor or medical professional on call.
The government should repeal all laws banning the sale and use of $1 home COVID-19 tests
There are presently several companies that can manufacture versions of the inexpensvie antigen test strips for pennies per strip: these can be sold for a dollar or less. Manufacturers include 3M[15], E25Bio, Sherlock, and Abbott. They are just waiting on the government to end its prohibition of the sale of antigen test strips for COVID-19 for home screening use.
All government agencies should “fast-track” the approval of such devices. The only requirement should be that test producers provide accurate information on their product – in this case, sensitivity and specificity. The best way to get out this information is to publish the results from a variety of private testing labs – it was these same private, non-government testing labs that found the original CDC government created test defective.[16]
Dr. Mina and economist Laurence Kotlikoff in a New York Times editorial describe some of the ways these tests may be used:
“Once they are provided to all, employers would likely require their workers to take time-dated pictures of their negative test results before coming to work. Colleges would require students to do the same before coming to class. Restaurants could accept reservations only if accompanied by negative-test pictures. In short, everyone will have an incentive to test themselves daily to participate fully in the economy and return to normal life.” [17]
What unforseen ways will the strips be used? I, or know one single individual knows. What is essential is that the state should not be in the business of prohibiting the use of such devices for a variety of purposes for which they were not originally intended, so long as no rights are violated. In other words the government should not do is micro-manage their use. The CDC and FDA can monitor such use, but such monitoring should not be an impediment to using the strips.
If a consumer wishes to pay for a test that is only 50%, 70%, or 80% sensitive, it is their moral right to do so. There is no safety issue in regard to antigen test strips, but rather one of efficacy.
The Declaration of Independence clearly states the purpose of the government is to protect people’s rights. No one’s rights are protected by banning cheap, easy to use, COVID-19 home tests.
With this simple action, the government can remove the chains that prevent bio-medical technology companies from providing us with cheap, rapid-response, scalable mass COVID-19 testing. Such testing, in conjunction with other public health measures, will put a severe dent on the spread of the COVID-19 virus. According to Dr. Mina, “We could reduce maybe by 90-95% transmission in this country in the next few weeks if everyone could have one of these tests tomorrow.”[18] Only mass-scale testing will put an end to the need for mass-scale lockdowns permanently.
Such testing, in conjunction with other public health measures, will put a severe dent to the spread of the COVID-19 virus, ending the need for mass lockdowns permanently. These tests are available now, and we have nothing to lose but our lockdown chains by using them. Laissez-faire COVID-19 home testing!
Recommended Links
- RapidTests.org has some recommendations on their webpage.
- Mike Mina video on This Week in Virology explaining “how we can break the back of this thing with cheap tests and fast turnaround times.”
- Paper: Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance.
- The COVID-19 Testing Group is a community resource for sharing the latest information on COVID-19 testing, prevalence, seroprevalence, and burden studies, planning tools, and data.
- FindDx has created a test kit roundup, scattered by sensitivity and specificity.
- An At-Home Contagiousness Test for COVID-19 Already Exists. Why Can’t We Use It? By Kira Peikoff, LeapsMag (August 25, 2020)
References
[1] SARS-CoV-2 (“severe acute respiratory syndrome coronavirus”) is the virus that causes COVID-19 (“coronavirus disease 2019”) the disease, similar to how HIV, the virus, causes AIDS, the disease. In this article, I use “COVID-19 virus” to mean the “SARS-CoV-2 virus.”
[2] Silverman, Justin D., et al. “Using Influenza Surveillance Networks to Estimate State-Specific Prevalence of SARS-CoV-2 in the United States.” Science Translational Medicine, American Association for the Advancement of Science, 29 July 2020, stm.sciencemag.org/content/12/554/eabc1126. Emphasis added.
[3] Fox, Maggie. “Study Suggests 80% of Covid-19 Cases in the US Went Undetected in March.” CNN, Cable News Network, 23 June 2020, edition.cnn.com/2020/06/23/health/undetected-coronavirus-cases-march-study/index.html.
[4] According to Wikipedia: “Polymerase chain reaction is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail. PCR was invented in 1984 by the American biochemist Kary Mullis at Cetus Corporation.”
[5] According to The COVID-19 Testing Group ” a community resource for sharing the latest information on COVID-19 testing, prevalence, seroprevalence, and burden studies, planning tools, and data”, COVID Test Turnaround times range from same day to up to 21 days to get results. https://larremorelab.github.io/covid19testgroup
[6] Wu, Katherine J. “A New Generation of Fast Coronavirus Tests Is Coming.” The New York Times, The New York Times, 6 July 2020, www.nytimes.com/2020/07/06/health/fast-coronavirus-tests.html.
[7] Mervosh, Sarah, and Manny Fernandez. “Months Into Virus Crisis, U.S. Cities Still Lack Testing Capacity.” The New York Times, The New York Times, 7 July 2020, www.nytimes.com/2020/07/06/us/coronavirus-test-shortage.html.
[8] Puiu, Tibi. “MIT Develops New, Cheap, Fast Covid-19 Test, Is Awaiting Approval from FDA.” ZME Science, 16 Mar. 2020, www.zmescience.com/science/mit-new-coronavirus-vaccine-15134/.
[9] See https://www.mayoclinic.org/diseases-conditions/coronavirus/expert-answers/covid-antibody-tests/faq-20484429 and https://www.businessinsider.com/difference-between-coronavirus-antibody-and-antigen-test-2020-5?op=1
[10] Comments Economist Raymond Niles, “Our armchair government planners have mandated this platonically “perfect” test on us that is too accurate. It is too accurate because such accuracy makes it very expensive and slow to obtain results. This reminds me of the argument in general against regulations. For example, a good way to reduce the number of car accidents is to mandate that everyone buy a new Cadillac, every year. That would reduce car accidents by taking most cars off the road. And the result would be a much higher overall death rate as people drive bicycles or used jalopies (if they were still legal).”
[11] “The COVID-19 pandemic has created a public health crisis. Because SARS-CoV-2 can spread from individuals with pre-symptomatic, symptomatic, and asymptomatic infections, the re-opening of societies and the control of virus spread will be facilitated by robust surveillance, for which virus testing will often be central. After infection, individuals undergo a period of incubation during which viral titers are usually too low to detect, followed by an exponential growth of virus, leading to a peak viral load and infectiousness, and ending with declining viral levels and clearance. Given the pattern of viral load kinetics, we model surveillance effectiveness considering test sensitivities, frequency, and sample-to-answer reporting time. These results demonstrate that effective surveillance, including time to first detection and outbreak control, depends largely on frequency of testing and the speed of reporting, and is only marginally improved by high test sensitivity. We therefore conclude that surveillance should prioritize accessibility, frequency, and sample-to-answer time; analytical limits of detection should be secondary.” — Abstract from ” Test sensitivity is secondary to frequency and turnaround time for COVID-19 surveillance”, Daniel B Larremore, Bryan Wilder, Evan Lester, Soraya Shehata, James M Burke, James A Hay, Milind Tambe, Michael J Mina, Roy Parker,
[12] Weintraub, Karen. “How to Stop the COVID-19 Pandemic? Harvard Doc Says Cheap Tests Are the Answer.” USA Today, Gannett Satellite Information Network, 9 Aug. 2020, www.usatoday.com/story/news/health/2020/08/09/covid-tests-cheap-home-tests-stop-pandemic-harvard-doc-says/3325446001/.
[13] Commissioner, Office of the. “Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools.” U.S. Food and Drug Administration, FDA, 2020, www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non.
[14] “[S]ensitivity – how likely it is to detect antibodies in the blood of coronavirus-positive patients – and for specificity – how good they are at distinguishing people who are infected from those who are not. A high specificity means a low false positive rate.” https://www.ucsf.edu/news/2020/04/417276/testing-tests-covid-19-antibody-assays-scrutinized-accuracy-ucsf-uc-berkeley. See also: https://www.evaluate.com/vantage/articles/analysis/spotlight/covid-19-antibody-tests-face-very-specific-problem and https://theconversation.com/will-the-new-15-minute-covid-19-test-solve-us-testing-problems-145285
[15] Shirley Goh | Deshpande Center for Technological Innovation. “MIT Team Collaborates with 3M to Develop Rapid Covid-19 Test.” MIT News | Massachusetts Institute of Technology, news.mit.edu/2020/mit-collaborates-with-3m-develop-rapid-covid-19-test-0714.
[16] Tucker, Jeffrey A. “How CDC/FDA Socialism Created The COVID-19 Epistemic Problem by Jeffrey A. Tucker.” Capitalism Magazine, Capitalism Magazine, 24 Mar. 2020, www.capitalismmagazine.com/2020/03/cdc-fda-covid19/. Carolyn Y. Johnson, Laurie McGinley. “A Faulty CDC Coronavirus Test Delays Monitoring of Disease’s Spread.” The Washington Post, WP Company, 26 Feb. 2020, www.washingtonpost.com/health/2020/02/25/cdc-coronavirus-test/. and Stein, Rob. “CDC Has Fixed Issue Delaying Coronavirus Testing In U.S., Health Officials Say.” NPR, NPR, 27 Feb. 2020, www.npr.org/sections/health-shots/2020/02/27/809936132/cdc-fixes-issue-delaying-coronavirus-testing-in-u-s. An argument should be made that it is these private labs working in competition with each other who should be regulating the FDA and CDC.
[17] Kotlikoff, Laurence J., and Michael Mina. “A Cheap, Simple Way to Control the Coronavirus.” The New York Times, The New York Times, 3 July 2020, www.nytimes.com/2020/07/03/opinion/coronavirus-tests.html.
[18] USA Today interview. Ibid.
