How to stop a pandemic in three short weeks

Editor’s note: The wrong version of this editorial ran in Wednesday’s edition of The Havre Daily News due to an error at the newspaper.

There has been a new proposal for testing to control the COVID-19 pandemic recently offered by Dr. Michael Mina, who is an assistant professor of epidemiology at both Harvard Medical School and the Harvard T.H. Chan School of Public Health. This is a game-changing, breakthrough proposal that can stop this pandemic in its tracks. I will summarize Mina’s findings here.

So far, the CDC’s efforts for COVID-19 testing have centered on diagnostic tests rather than screening tests. The difference is a diagnostic test must be performed in a laboratory, requires specialized equipment to complete and interpret (as in the case of PCR testing) and results are usually obtained in one to seven days. Such tests are relatively expensive — $35 to $200 per test — but have very high sensitivity and specificity to detect very low viral counts. There are also screening lab tests (such as antigen tests) available for COVID-19 that are paper tests which detect viral antigen, that are obtained by outer nasal swab for a sample, that can be done at home similar to a pregnancy test, require no specialized equipment and results are obtained in 10-15 minutes. Also antigen tests are cheap, would potentially cost about $1 to $2 a test, and could be rapidly produced in the millions.

Antigen tests were considered when this pandemic began but were overlooked because they can only detect viral loads (viral counts) of 100,000 viruses/sample or more whereas PCR tests can detect viral loads as low as 1000/sample. So PCR tests are better, right?

Wrong. Turns out the antigen tests detect 100 percent of those that are infectious or contagious. Studies have shown that to become contagious, a person has to have a viral load of 1 million or more per sample which antigen tests can easily pick up. OK. So what about the PCR tests that we are using now? If a person tests positive on a PCR test, what are the chances that that person is contagious? You won’t believe how low it is. According to Mina, it is about 5 percent.

How can this be? For those that never develop symptoms or only have mild symptoms, studies have shown that they are contagious for only about seven days. Granted, persons who are ill enough to be hospitalized are likely contagious for longer. There is a period before one becomes contagious or ill when the virus is reproducing and growing in numbers and a period after one becomes contagious or ill when the virus is being eliminated by the immune system and viral numbers are decreasing. The PCR test would be positive in both of these cases whereas the antigen test would be negative.

Consider the following analogy. Let’s say you’re a firefighter. A firefighter doesn’t want to respond to any and every fire, just the fires that are out of control. So if someone is roasting marshmallows over a campfire, or if someone is lighting their propane grill, the firefighter doesn’t need to respond to that. The PCR test can detect every little fire whereas the antigen test only detects those that are out of control.

What we care about is detecting those that can transmit the virus and to quarantine them only. We need a cheap test that can be performed daily, or near daily, by the vast majority of the American people so that we can identify who those people are, not a test that can only be performed once a week or so due to expense. And we also don’t need a test that takes so long to get a result that, by the time the result is known, the person involved will likely no longer be infectious but has had up to a week while he or she was potentially infectious to spread the virus to others. Granted if a person had symptoms suspicious for COVID-19 infection and went to the clinic, that person would be told by health care providers to stay home while awaiting the test result, which would prevent that person from spreading the virus. But what about the asymptomatic carriers? Very few people without symptoms are being tested at all but we know many of them reach high enough viral loads to become contagious. A daily cheap antigen test would identify those individuals who could then quarantine at home.

These paper antigen tests have the ability to get this pandemic under control rapidly, but government regulations are in the way. The FDA has required that any lab test for COVID have 80 percent sensitivity as compared to the gold standard PCR test, which means they must be able to detect very low viral numbers and they will not authorize any test to come to market that doesn’t meet that standard. And antigen tests are nowhere near that standard because they can’t detect low viral numbers. Their sensitivity is around 50 percent. The FDA doesn’t seem to understand the concept that we only care about whether or not a person is contagious and it doesn’t matter if they harbor the virus if they are not contagious.

Yet, imagine how these paper antigen tests could stop this pandemic. If they cost $1 a piece or less, are cheap enough for consumers to purchase and use on a daily basis, we could 1) determine when it is safe for students to return to school, 2) determine when it is safe for workers to return to the workplace, 3) protect patients in hospitals and nursing homes as well as medical personnel. If a person had a negative result, he or she could go back to work immediately, back to school immediately, visit grandma in the nursing home immediately or immediately visit a loved one who is dying of COVID-19 in the hospital rather than having to say his or her final goodbyes on Skype.

The antigen test is extremely simple to interpret. Just like a pregnancy test, one band means a negative test, two bands mean a positive test. One company that currently makes this test is E25 BIO, based in Cambridge, Massachusettes a company that consists of only 3 employees and they estimate they have the capability to produce a few million tests per week. And they are willing to share their method with other companies in every state so these tests can be mass produced.

What about developing a vaccine instead? Isn’t that more important? In short, no. Developing a vaccine is important, don’t get me wrong, but vaccines are very difficult to develop, take a very long time to develop (they take ages to develop if you consider how rapidly this pandemic spreads and how many people are dying every day) and usually offer protection against less than 50 percent of strains of any particular virus. It would be vastly cheaper to develop these screening paper antigen tests on a massive scale. We are already spending billions to develop a vaccine. Yet, to produce these paper antigen tests on a massive scale would be a fraction of that cost.

Aug. 15, the FDA announced it approved the SalivaDirect COVID-19 diagnostic test developed by the Yale School of Public Health. This is a rapid saliva test that is estimated to cost $4 per test. However, it still requires you to go to the clinic to get one done and it is not practical for everybody to go to clinic every day to be tested. And any test that is performed in a clinic is billable through insurance which will further add to the cost. It’s a step in the right direction but not near enough.

If a poor college student has to stay up all night to study for finals, and he has only $5 to spend on coffee, he’s better off buying instant coffee so he can have 5 cups rather than buying one $5 expresso. We need the instant coffee version of this test, not the fancy expresso version, so we can employ frequent testing which will allow our economy to recover and allow our lives to return to the “good old days” before this pandemic.

Mina has proposed that we need to bypass the FDA. I concur. I also agree that a less stringent testing certification program be developed, perhaps by the CDC, but what is crucial is that these tests be allowed to be mass-produced essentially as they are, so that they will be affordable to the public on a daily or near daily basis. If ANY regulations are added to these tests, the cost will likely increase several-fold. In addition, deciding about what regulations to put on them and how to enforce them, etc would greatly delay their availability to the consumer. And as everyone knows, we don’t have time to lose. There are still about 500 to 1000 people in the U.S. dying each day from this pandemic. As Mina explains, there are companies that can mass produce these tests now, but cannot do so because they fear they will be shut down by the FDA because they don’t meet their inappropriately high sensitivity standard.

In short, the paper antigen test would identify virtually all the asymptomatic carriers that are truly contagious and this would prevent the spread to multiple persons, who in turn could spread it to multiple persons. We can break the chain of transmission early using these tests, if only our government will let us do so. Mina estimates that if we can produce these tests on a scale of hundreds of millions per week or per day, he believes the COVID-19 epidemic in this country would be contained within three weeks.

I encourage individuals to contact their lawmakers to encourage them to author or co-author a bill that would allow these tests to be produced as screening tests, not diagnostic tests, so we can bypass the FDA and allow them to come to market over the counter.

For more information about rapid antigen testing, see “Failing the Coronavirus-Testing Test” at http://harvardmagazine.com or visit http://rapidtest.org .

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Terence “Terry” Hankins, D.O., is board-certified in internal medicine and have been employed at Northern Montana Hospital as a clinical internist and hospitalist since 2012.