Is Your COVID Test Legit?

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October 9th, 2020

By Beth Crocker


Back in late March, just a few weeks after several states went into lockdown to prevent the spread of COVID 19, the FDA gave emergency approval for rapid coronavirus testing that would deliver results in less than an hour.  Rapid tests present some clear benefits, among them portability, ease of use, and fast results. The introduction of an instant test seemed almost too good to be true, especially considering the test result bottleneck that many experienced in the early days of COVID.

But are these rapid tests reliable? Perhaps the conventional wisdom is correct – if it seems too good to be true, it usually is.

The spread of the novel coronavirus at the White House, the Pentagon, and several college campuses, offers a cautionary tale about the merits of rapid COVID testing.  Just a few months after their release, New York University and Columbia University both reported that rapid tests are highly prone to false negatives. NYU suggested that these tests could be missing close to half of positive cases. Columbia University researchers found that rapid tests identified only 74% of infectious samples.   These tests lack the high sensitivity required to discover the presence of coronavirus until a person has a substantial viral load.

What this means is that a person can become infectious days before they register as positive on a rapid test, and potentially infect others under the false assumption that they themselves are not infected. With the need for expedient, cost-effective COVID testing urgent, the allure of inexpensive, rapid tests is apparent.  That said, the combination of high false negatives and the false sense of security that a negative result offers may render these tests more dangerous than helpful.

Now for the scary part.

Rapid tests are about to be delivered en masse to countries, schools, and businesses.  The World Health Organization in partnership with at least two rapid test providers has plans to sell 120 million tests to low- and middle-income countries.  One provider offers testing technology that is accompanied by a smartphone app that allows the user to share their test results instantly.  The app “works like a secure digital ‘boarding pass’ that can be scanned to enter organizations and other places where people gather.”

Armed with a digital boarding pass, will people be lured into a false sense of security and relax other health and safety protocols?

Diagnostic laboratories continue to provide the gold standard in COVID testing, known as PCR testing (which stands for polymerase chain reaction). While these tests can take longer to process, they are far more accurate. Moreover, people tend to take more precautions while awaiting the results.  One example of a testing success story is Cornell University.  Martha Pollack and Michael Kotlikoff co-authored an Op-ed piece for the Washington Post, where they share their COVID-19 testing and contact tracing protocol.  The university is currently testing more than 30,000 individuals per week using its own testing lab and a partnership with Cayuga Health.

Dr. Charles Mikel, Founder and Principal Scientist at Nightmaker Science, had this advice to offer regarding key testing requirements for large groups of asymptomatic students, “It is important to have very high negative predictive value, but also high sensitivity.  If a student tests negative, the university must be confident in the accuracy of that negative result.  If a student is positive, they are quickly identified, and can be quarantined before they spread the disease.”

With hindsight 20/20, we now know that rapid COVID tests alone are not sufficient to protect groups from spreading COVID. Put simply, rapid tests should not be considered a replacement for tried-and-true diagnostic lab testing. More importantly, a negative result should not be considered permission to waive the need for social distancing and wearing masks. While rapid tests can be a powerful tool in the arsenal to fight the pandemic, the public should be educated to their short-comings and continue to rely on lab testing, along with the safety practices that have become commonplace during the pandemic – social distancing, contact tracing and wearing a mask.

In the Fight Against Coronavirus, the Feds May Have Done Something Right


August 29th, 2020

By Gregory A. Stein and James Dieter


Everything from op-eds to angry tweets are being written about the US Government’s apparent missteps in addressing the Coronavirus (COVID-19) pandemic.  Buried in the back pages, however, are new regulations implementing the 21st Century CURES Act (Cures Act) that may have a powerful impact on combating the disease).

The Cures Act was enacted to accelerate medical product development and deliver innovative healthcare advances to patients who need them faster and more efficiently. Signed into law in December 2016, these regulations provide protections for technology companies enabling them to improve patient care through innovation, integration, and information transparency.

The new regulations encourage technologies designed to help patient data flow more efficiently across the healthcare ecosystem, while still maintaining patient privacy and security. It also prevents technology incumbents from blocking a clinician or patient’s access to the electronic health information stored on their systems.

So how does this enhance the fight against Coronavirus? Part and parcel to ubiquitous access to Coronavirus testing, is ensuring that information flows quickly and efficiently to the right place. To stem the tide of the virus, we need to know who has been exposed, how they are reacting, and whether to quarantine in place or hospitalize.  All these data points can be answered by diagnostic laboratory testing – and laboratories are responding.

Diagnostic laboratory companies like Principal Health Systems (PHS) have developed tests to address these concerns. PHS is specifically focused on nursing home care, where the risk of dying from COVID-19 can be as high as 15%. Early testing can clearly save lives, especially for those who are at high risk.  However, the availability of testing is merely half the battle, the other half is getting those tests into the hands of doctors as quickly as possible.

Today, if a clinician wants to order one of these lab tests, that lab must be “integrated” into that clinician’s electronic health record (EHR) software.  But what if they aren’t?  In that case, the clinician must write an order on a piece of paper and – we aren’t kidding here – FAX it to the lab.  In some cases, the lab may have an online ordering portal, but even then, the clinician must now perform data entry which is both time consuming and a high potential for error.

If the lab wants to integrate with that clinician’s EHR, they must be willing to invest thousands of dollars per location, commit internal IT staff, and if everything goes smoothly, get the integration up and running in a few months.  In the crisis environment in which we are operating today, this is simply unacceptable.  We don’t have a few months to make tests available everywhere.  Even a single days’ delay can result in exponential expansion of infections.

The CURES Act now allows labs and doctors toinstantly integrate.” This means the innovative lab paired with the innovative software technology can offer tests to clinicians within minutes of a request.  Technology companies such as Shadowbox are specialized in the lab and healthcare integration space to accelerate the integration of systems to allow doctors to electronically order a test from an otherwise non-integrated lab that day.  These orders and their results are securely, compliantly, and securely exchanged between systems in seconds.

We believe that every person desiring to be tested for COVID-19 should have access to, and payer support for, immediate and periodic testing; for peace of mind, for informed behavior changes, and for the sake of protecting our loved ones and community. While there is still much to do to ensure the widespread availability of diagnostic tests, The CURES Act rules now make it easier and far faster to access those tests and receive results.


Gregory A. Stein is the Co-Founder and CEO of Shadowbox, Inc. – a technology start-up bringing disruptive innovation to healthcare.

James Dieter is the Founder and CEO of Principle Health Systems – a multi-faceted healthcare ancillary services provider focused on services and support for skilled nursing facilities, hospice, and at-home healthcare organizations.