Four reasons why COVID-19 testing is not just the test itself.

Kyle Tretina, Ph.D.

Kyle Tretina, Ph.D., Genomics Application Scientist

The test is not just the test, and the CDC is not helping

Ata time when 137 million people[1] in the U.S. are already facing serious financial problems due to medical debt, many Americans are concerned about the cost of COVID-19 testing and prevention when getting back to work[2]. While the U.S. Centers for Disease Control and Prevention (CDC) has finally provided broad guidance for re-opening their businesses[3] in the face of a pandemic, these instructions fall very short in providing a comprehensive and actionable plan for businesses when it comes to testing. For example, while the American’s with Disabilities Act[4] permits employers to require a doctor’s note from employees to show that they are healthy to return to work, the recent CDC guidelines[3] undermine this by asking employers to not require such a test. These guidelines also leave the following glaring issues that companies have with testing to be solved by the employers themselves.


Figure 1. A map of testing sites (black dots) compared with business density in the United States (see legend). Note the miles of blue space with companies but no nearby testing facilities in the west. Zoomed-in views can also be used to see gaps in testing even in parts of the country with high concentrations of businesses.

REASON #1: There is a glaring inequality in COVID-19 testing supply availability nationwide.

Finding a reliable, accessible testing supply is difficult or takes too much time for some people[5]. Despite an overall increase in the amount of COVID-19 testing in the U.S., it is becoming increasingly clear that there are substantial barriers[6] to specific vulnerable populations[7] of employees that want to be tested. For many people, poverty, race and ethnicity have been pre-existing conditions[8] in this pandemic. Insurance companies have [9]in their responses to the pandemic, but often will not cover a COVID-19 test, especially if those people are asymptomatic or do not have multiple symptoms on the CDC’s symptom list[10], despite recent estimations that as many as half of SARS-CoV-2 patients are asymptomatic[11]. These problems can be even more obvious in rural regions of the U.S., where a single testing facility can be the only option for many miles (Figure 1). Testing rates vary by state[12] from 0.5 tests per 1,000 people (Oregon) to 4.0 tests per 1,000 people (Alaska) at the time of this writing. In Puerto Rico, the week[13] of June 22nd, 2020, 100% of the 221 tests performed were positive for COVID-19, indicating a vast under-testing in this U.S. territory. COVID-19 testing problems[14] have been one of the few consistent features of the U.S. response to the epidemic, as shown by the thousands of tests that are going unused[15] because of a lack of a national plan to coordinate testing. Americans need the right tests, at the right time, at the right places, and for many of them that isn’t possible right now.

REASON #2: Most employers are not prepared to navigate the variety of lab and test choices.

Unless you are a subset of medical or science professionals, there are some difficult decisions to be made when it comes to coordinating an effective, informed COVID-19 back to work program. The US Food & Drug Administration (FDA) has provided a document called the Policy for Coronavirus Disease-2019 Tests, which lists over 150 testing labs[16] under Section IV.A to choose from. Sample collection and shipping requires medical expertise[17], unless you are using the new at-home test kits[18] recently approved by the FDA. Managing the testing site in an efficient manner that does not put your employees at risk for exposure is not straightforward[7], especially for certain work industries where close proximity between employees or with particularly susceptible groups of people is unavoidable.


Figure 2. A PAC-MAN word cloud of the >150 lab name choices available to employees, illustrating the difficulty in choosing a lab.

REASON #3: Unless you are changing human behavior, testing is just measuring how ineffective your back to work program is.

Perhaps the most obvious issues that companies are having is with the CDC guidance for testing[19], as listed in the Overview of Testing for SARS-CoV-2[7]. In this document, they make recommendations for five groups of people:


Table 1. CDC testing guidelines[7] summarized by group. * = long-term care facilities, correctional and detention facilities, homeless shelters, other congregate work or living settings, including mass care, temporary shelters, assisted living facilities, and group homes for individuals with intellectual disabilities and developmental disabilities, and high-density critical infrastructure workplaces where continuity of operations is a high priority.

The main problem with these recommendations is that they are not specific and not practical. Even for employers who want to have a testing program, at a cost of ~$100–200 per test per employee, many businesses can’t afford to test all of their employees according to these suggestions. In those cases, these guidelines are not specific enough to implement an actual testing plan, particularly for large companies with complex geographic and organizational structures. Using category “C” as an example (Table 1), the CDC recommends employers should “have a plan in place for how [testing] will modify operations based on test results”. The mathematical[20] and observational data from China[21], South Korea[22], and elsewhere[23] suggest that testing can be effective in preventing an outbreak as part of a larger strategy that includes quarantine, social distancing and contact tracing. But how are employers supposed to come up with such a data-driven plan in the absence of help from an epidemiologist or public health expert? How do they come up with the minimal amount of testing (cost) with the maximum amount of protection (benefit)?

REASON #4: Returning to work is a potential public relations disaster.

The Equal Employment Opportunity Commission (EEOC) recently updated its recommendations on the Americans with Disabilities Act (ADA) and COVID-19, specifying that employers may screen employees for COVID-19. Despite the fact that employees who contract COVID-19 at work seem to have little to no legal support[24] against their employer, back to work programs seem to be striking a cord as a way to differentiate their workplace from their competitors and build trust with current and potential employees. Recent polls such as this one[25] are finding that employee expectations have changed a lot since the pandemic started, particularly when it comes to disease prevention and management effort (protective gear, closed plan work layouts), and working from home. Employers who want to fulfill these expectations, however, are finding themselves faced with difficult, new challenges that they are often ill-equipped to handle: coordinating medical oversight for test sample collection, managing health information privacy and security, interpreting molecular test and results and symptom combinations, and most importantly, maintaining and quantifying compliance to the back to work program. Employers are now caught in a conundrum — their employees want them to prevent an outbreak at work, but are often uncomfortable[26] with the inconvenience and invasiveness of the approaches that actually provide protection (testing, contact tracing, quarantine, etc.).

The real test is the plan.

The workplace exodus that accompanies the early phases of the pandemic resulted in the exposure of the mistrust between some employers and their employees[27]. The true test that employers have in getting back to work is in developing a complete plan that builds trust with their employees while keeping them safe. This is no small feat, and will require the input of our greatest minds in medicine, science, sociology and business to fill the gaps and provide a new direction for a new era of workplace ideology.

References

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Kyle Tretina, Ph.D.

Kyle Tretina, Ph.D.

Kyle has extensive research expertise and interest in the area of genomics, microbiology and immunology. He received his Ph.D. from the University of Maryland, Baltimore working at the Institute for Genome Sciences and came to Meenta from a postdoc at Yale University.