Why Some COVID-19 Testing Protocols Aren’t What You Think

Pawel Czech, Founder of Nex.DWhile countries around the world continue to flounder with regards to COVID-19 testing, everyone is wondering how national governments could get things so horribly wrong. It’s true that governments have acted incompetently, leaders can make poor judgment calls, and optimistic testing targets are rarely achieved.

But the claims of various ambitious big pharma companies—about their ability to deliver on capacity and accuracy alike—have created a smokescreen for decision-makers, one that has severely undermined crucial efforts to monitor the spread. They say the hunt for profit leads to innovation, but it can also lead to chaos.

As Jonathan Quick, author of The End of Epidemics put it: “Virus biology and vaccines technology could be the limiting factors [to COVID-19], but politics and economics are far more likely to be the barrier to immunization.”

The time it takes for people to get tested and receive results (end-to-end) has been a significant point of contention in the testing sphere. Some solutions, especially in the pandemic’s infant stages, were keen to position themselves as the go-to protocol, particularly at a time when governments were frantically pouring money into testing, hoping it would give people the confidence to return to work and reopen parts of the economy.

In their quest to promote their own protocols in the best possible light, some companies have publicized processing times that don’t span the time it takes to actually complete the entire testing process. Others have shone a light on their own testing advantages. 

Disadvantages have not only been obscured but sometimes outright manipulated or fudged to appear more appealing and competitive to the average Joe, whose statistical interests lie more in Fantasy Football than the intricacies of testing methods. For instance, in our test comparison study, Abbott’s RealTime SARS-CoV-2 test took approximately 7 hours of end-to-end processing time. It’s the claim of 90-minute completion, however, had been widely publicized, leading several budding admirers, including the White House staff, to quickly commit to its protocol. This 90-minute-only accounted for one stage of its testing protocol. 

Testing companies have also recognized the value of promoting high-capacity protocols. Testing capacity ultimately boils down to the volume capabilities of each testing machine, versus the availability, cost, and a number of these machines required to complete a test.

When some companies promote their testing capacities, the figures produced don’t always mention the cost attached to each machine or the number of machines required for the full testing process. PCR tests tend to have low throughput, laborious process, and often false-negative results, making it overwhelmingly challenging to meet testing needs even in industrialized countries. But, as the world has come to know all too well, statistics can be massaged when presented in a preferred light.

Initially, testing companies prioritized promoting low-turnaround times and enhanced sensitivity. It was only after the preliminary stages of the pandemic when capacity became more of a trait to consider. This has led some test makers to highlight testing capacity in rather vague terms, presented as daily output as opposed to capacity per machine. As a result, certain companies utilizing PCR protocols have veered away from disclosing their throughput numbers. 

False negatives pose an enormous problem because they literally mean people who have COVID-19 will go out into the world in full confidence that they don’t have the disease, and infect others. Such people are less likely to self-isolate or even exercise very basic precautions, such as wearing a mask because they are convinced they aren’t contagious. 

In its own COVID-19 testing policy for labs and commercial manufacturers, the FDA says a diagnostic test should correctly identify at least 95 percent of positive samples. Yet, even 95 percent does not give us the scientific precision we might require to truly quell the spread. It gives us a probable threshold, but false negatives are still likely to leak through, causing further potential spread as a consequence. 

When the White House itself began screening its staff using a rapid coronavirus test made by Abbott Laboratories, they didn’t expect post-analysis studies to conclude the test may return a high percentage of false-negative results. In mid-May, the Food and Drug Administration issued a rare public warning about an Abbott Laboratories COVID-19 test: test results could be wrong. The lower 80 percent threshold for the Abbott and other point-of-care tests’ sensitivity proved insufficient. As such, governments fell into the trap of buying into solutions with plenty of initial hype, but less verifiable agency. 

For some of us, much of this information can seem completely contradictory, just like the old “Coffee is good for you… no, wait it’s bad for you… no, wait, it’s good for you again,” repeated ad nauseam. Understandably, media coverage of the COVID-19 pandemic has continued on full blast since the onset, this has inevitably led to a sense of informational fatigue for certain sections of society.

Tidal waves of medical statistics and information crash over us each and every day. During a global pandemic, this vulnerability to medical gossip only intensifies, meaning health authorities, as well as providers, should be re-doubling efforts to create clarity with regards to prevention; safety restrictions, testing protocols, and limitations. More clarity must be prioritized by competent legislators making vital decisions regarding institutional/national testing protocols.

More needs to be done to separate state and big pharma medicine, that’s because medical research is often financially backed by private entities. E.g. Antidepressants can be life-savers for some people. But drug company-funded studies have overplayed their benefits and downplayed their harms, contributing to overuse and unnecessary side effects.

It would be naive to think that financial gains are not a factor for budding testing companies, it would also be naive to expect that when testing companies recognize their own protocol shortcomings in the market, they will readily disclose it. Their aim is to move their product forward, not necessarily by deception, but also not always by full disclosure either. While this might be common ground for many industries, life-saving testing companies need to do better.

As Gerald Posner, author of Pharma: Greed, Lies, and the Poisoning of America, puts it: “Pharmaceutical companies view COVID-19 as a once-in-a-lifetime business opportunity,” adding that, “the worse the pandemic gets, the higher their eventual profit.” With potentially lucrative government contracts up for grabs, the clamor to present your testing solution as the answer to COVID-19 grew.

What many testing companies seem to have forgotten is that initiatives focusing on the protection of the public from a potentially terminal virus should, in no way, shape, or form, be employing misleading statistics and marketing tactics when the alternatives to effective prevention are so grave.

These companies carry a crucial responsibility: They are not simply providing the public with non-essential products for which you can choose to enjoy or not, the product here is medically crucial, and the fate of the health and livelihoods of millions of people across the globe depend on it.

About Pawel Czech

Pawel has led market entry for three global tech companies into 45 countries. Pawel specializes in helping prepare companies to scale into multiple markets with a full stack offer. Pawel founded Nex.D to be the company he would have wanted to work with as a founder. Pawel has held three global roles in the technology sectors in the last 15 years working extensively in business development, operations, and sales capacity actively serving in a governance and leadership role with those founders and management teams.

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