Testing, Testing, Testing…by Angela Rieck

One of the most frustrating aspects of this pandemic is the contradictory, confusing and frightening information that we receive daily. To get accurate information, we need accurate and valid tests.

In an effort to give us broader access to COVID-19 testing, the FDA provided Emergency Use Authorization (EUA) which only requires validation from 20 to 30 test samples. If you read my columns, you know that these are small samples; and some of the confusing data is due to the speed with which these tests have been created. But in a crisis, we must move quickly.

There are basically two types of tests for COVID-19 (although the FDA classifies 3.)  The first test, sometimes called an antigen test, looks for copies of the virus via nasal and throat swabs in patients who show symptoms of the virus. (As a recipient of this test, I can assure you it is very unpleasant.)  Fortunately, the FDA has approved a saliva test.  

The other test is an antibody test, designed to test antibodies generated after the symptoms of COVID 19 have passed.

The only way to assess the accuracy of the first test is to compare it to the results from the second type of test, the antibody test, using a nonparametric test for statistical significance.  Simply put, if you tested positive for the virus in the antigen test, and have the antibodies, the antigen test was accurate.  If you tested negative but have the antibodies it could be a false negative.  

The critical test to get us back to “normalcy” will be the antibody test. Despite wide-spread availability of antibody tests, only four have met the minimal EUA standards.  Some of the unapproved tests, often from Chinese manufacturers, have reliabilities as low as 20%.  (In psychological testing, we reject any reliability less than 95%.)

We know that an accurate antibody test is needed to enable us to “get back to normal.”  Some scientific modelers accept that 40% of the population with antibodies can create “herd immunity” thus making it safe for us to resume our normal routine. But most prefer 90-95%.  In addition, some experts predict that the antibody test will demonstrate that many more have recovered from the virus than our current statistics suggest.

Here is what appears to be true from data that has been gathered.  Approximately 10% (in Florida) to 13% (in Iceland) of those who are symptomatic test positive for the disease.  According to the article in the New England Journal of Medicine, Icelandic researchers found that .8% of the population who are asymptomatic test positive for the disease.  

I am a numbers person, and given everything that I have read, it is obvious that we will not have a herd immunity in the near future. Our current infection rate across the United States is less than 1%. With only 10%-13% of those being tested with symptoms having the virus, and only .8% of a percent without symptoms having the virus, it is unlikely that more than 2% of the population will be “immune”. Even the most optimistic projections predict that only 5% population will have antibodies.  In Wuhan, it is 3%.  New York City, currently writhing from the illness, only a little over 1% of its population has tested positive.  You can do the math.

So what next?  For now, it will be a balancing act between our flailing economy and our health.  I leave it to the experts to make those decisions.

But what is critical is that this is the time to think longer term:  VACCINE and TREATMENT.

According to the New York Times, 35 startups, Universities and smaller medical companies are working on COVID-19 vaccines. Three vaccines are currently being tested in human trials.  However, the scientific community warns us this virus may be resistant to a vaccine.  

Sadly, vaccines are not profitable enough for our largest resources, big Pharma, because vaccines have a low profit margin.  

Since this and other viruses will be with us for some time, we need to focus on developing treatments. Vanderbilt University Medical Center is testing a new antiviral drug, Remdesivir. But there is little in the drug pipeline.

So, how can we prioritize both treatment and prevention?  I leave it up to the experts, but here are some of my “top of the mind” thoughts.

1. First and foremost, we must make vaccine and medications to address pandemics profitable. It could include tax breaks, research funding, extended patent protections.  
2. How about creating a prestigious award, with a significant revenue attached, for collaborative efforts that yield products for COVID-19 and future pandemic viruses?  Let’s face it, the best products come from collaboration.
3. Finally, funding, I personally would be happy to pay a dollar for a “pandemic tax”. Of course, only if the revenues were awarded by independent Federal agencies (e.g., CDC, FDA, NIH) to US medical companies and “out of reach” of politics.

Rather than believing that this is something that we need to get past; it looks like we must recognize that this is part of our future.    Some infectious-disease experts believe the scientific tools already exist to develop vaccines and drugs that work against a wide range of pathogens. We need to create a global monitoring system to identify and monitor potential high-risk viruses. 

Our scientists and medical professionals are racing to find the answers, but in this crisis, it is hard to give them what they need the most.

Data, patience, funding and leadership.

Angela Rieck, a Caroline County native, received her PhD in Mathematical Psychology from the University of Maryland and worked as a scientist at Bell Labs, and other high-tech companies in New Jersey before retiring as a corporate executive. Angela and her dogs divide their time between St Michaels and Key West Florida. Her daughter lives and works in New York City.