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7/9/20 COVID-19 Brief: to Test, or Not to Test - That Is the Question

The idea of testing employees as part of the effort to return them safely back to work has a lot of appeal. On the surface of it, it makes great sense. Unfortunately, below the surface, there are numerous considerations that make decisions about testing a lot more complicated.

A Message on COVID-19 from WorkSTEPS Chief Medical Officer Dr. Ben Hoffman

COVID-19 RTW: to Test, or Not to Test – That Is the Question

Sometime in the past few weeks there must have been a story in the WSJ or a segment on CNBC or something that has gotten business executives thinking about testing asymptomatic employees for COVID-19. I say this because there has been a sharp uptick in C-Suite-driven questions about demand for employee testing. We’ve noticed it in our business, and it’s been a hot topic among my medical director peers.

The idea of testing employees as part of the effort to return them safely back to work has a lot of appeal. On the surface of it, it makes great sense. Unfortunately, below the surface, there are numerous considerations that make decisions about testing a lot more complicated. A recent article in the New England Journal of Medicine identified a number of issues, including:

  • Timing: Molecular testing (a.k.a. PCR testing) yields a valid result for only the point in time when the specimen was obtained. Implication? Someone who tests negative today may test positive tomorrow.
  • Consent: If testing is arranged by an employer, results can only be returned to the employer with employee consent. Otherwise, employers need to rely on self-report of test results. Implication? Administrative burden and a potential reliability gap due to self-reporting.
  • False Positives: People who have had COVID-19 but who are no longer contagious may test positive because tests may interpret harmless viral fragments as the presence of an active virus. Implication? False-positive tests on people who are no longer sick can result in unnecessary quarantining of workers.
  • Quality: PCR test reliability is dependent on both the quality of the specimen obtained and of the laboratory performing the analysis. Implication? Mistakes will likely be made.
  • Turnaround Time and Availability: Testing supplies are in limited quantity and labs are backlogged. Implication? You may not be able to get testing done on-demand, and results may be delayed.

In addition to the above, companies need to consider the total cost of testing, including the cost of the tests themselves ($100 to $150), plus the cost of clinical personnel to administer tests, the infrastructure needed to administer tests, manage test-related permissions and information, and the communications burden of test implementation.

So, To Test or Not to Test?

If the question is: Should our company test all of our employees? the answer is: “probably not at the moment”

However, that doesn’t mean testing shouldn’t play an important role in keeping employees and customers safe. Most companies can justify testing certain employees based on specific use cases. Some examples of use cases:

  • A health care organization may want to regularly test (e.g. 1-2 times per week) their front-line workers.
  • Nursing home and senior living operators may also want to test employees who work in close contact with vulnerable populations on a regular basis.
  • Oil & Gas companies and power generators may want to test workers whose jobs require that they work (and sometimes live) in close quarters with other employees, contractors and customers.
  • Companies may want to test employees who must fly domestically or internationally upon return from travel to rule out disease and avoid unnecessary quarantine.
  • Companies may want to test employees who are identified through contact tracing as having been in close contact with an infected employee to rule out disease and avoid unnecessary quarantine. This use case could be expanded to all employees in a facility where there has been an outbreak of disease.

Developing a Use Case Testing Strategy

To develop a testing strategy, we recommend organizations implement the following process:

  • Pull together a multi-disciplinary team with representation from health & safety, HR, operations and legal
  • Identify a list of potential use cases. For each use case identify the group affected (who, where, how many), the rationale for testing, and any special logistical considerations, such as needing consent forms in different languages.
  • Prioritize use cases based on risks, total costs (including administrative) and business needs.
  • Prepare for/roll out testing use case by use case, looking for efficiencies and applying learnings as you go.
  • Monitor and update. As testing technologies become cheaper and more reliable, and as your organization develops muscle memory around testing protocols, it will make sense to use testing for more and more use cases. Until that time, organizations should be strategic and selective in the use of tests.

Testing Doesn’t Replace Prevention

Even the most comprehensive approach to testing cannot guarantee that infected employees won’t show up to work where they can infect others. Companies must remain vigilant in implementation and enforcement of their COVID-19 prevention strategies.

How is your organization using testing as part of its COVID-19 strategy? If you have insights to share that others might find valuable, please let us know.

Finally, if your organization needs help identifying and prioritizing use cases or implementing testing protocols, know that we have built up a full range of capabilities to meet your needs. You can learn more about our services here.

Ben Hoffman, MD, MPH
Chief Medical Officer, WorkSTEPS

For more from Dr. Hoffman, connect with him on LinkedIn.

Medical:


Area Reported Cases Deaths Recovered
Global 12,035,661 548,434 6,958,736
United States 3,117,559 134,166 1,355,898

Source

This chart ranks the countries with the most confirmed new cases over the past week, adjusted for population size, and treats each US state as if it were a country. (Many states are larger in both landmass and population than some countries.)

The US has crossed the 3 million mark with COVID-19 cases, almost exactly a month after it recorded 2 million cases. More than 130,000 people have died, and states in the South and West — especially Florida and Texas — continue to be dealing with record numbers of cases and hospitalizations. Texas, for instance reported a 47% increase in hospitalizations yesterday compared to last Monday, and Florida posted a record high of nearly 11,500 cases on July 4. In response, the mayor of Miami-Dade County — which has seen 25% of Florida's nearly 207,000 cases — yesterday announced rolling back business openings, including of restaurants and bars.

The CDC reported 2.84 million total cases (52,228 new) and 129,576 deaths (271 new) on July 7. The US has reported more than 50,000 new cases for 4 consecutive days, including a record high of 57,718 on July 4. In total, 21 states (increase of 2) and New York City reported more than 40,000 total cases, including California with more than 250,000 cases; New York City with more than 200,000 cases; and Florida, New York state, and Texas with more than 175,000. The current daily incidence in the US is more than 50% higher than its first peak in mid-April. The daily incidence has more than doubled since June 9, up from 20,338 new cases per day to 47,389 yesterday (7-day average).

Airborne Transmission: The WHO, CDC, and other experts have continually emphasized that respiratory droplets are the main driver SARS-CoV-2 transmission; however, 239 scientists from 32 countries are reportedly challenging that notion in an open letter to the WHO. The authors argue that airborne transmission may be playing a larger role in the pandemic than previously believed, which would significantly impact future prevention strategies and the resources needed to fulfill them. While droplet transmission risk can be mitigated via physical distancing and barriers like face shields and face masks, airborne transmission would mean that virus particles could linger in the air for prolonged periods of time or travel longer distances, including via ventilation systems, instead of quickly settling on surfaces.

Antibody Testing for Coronavirus Disease 2019: Not Ready for Prime Time: Bastos and colleagues provide a much-needed review of the performance of serological assays to accurately detect antibodies to SARS-CoV-2. They meta-analyzed 40 studies according to type of antibody test (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), and chemiluminescent immunoassays (CLIAs)), and for each type, determined the average or pooled sensitivity and specificity and assessed the studies for risk of bias. Only four of the 40 studies included outpatients and only two studies assessed LFIAs at the point of care.

Guillain–Barré Syndrome Associated with SARS-CoV-2:  Italian study has identified patients who had the onset of Guillian-Barre syndrome following COVID infection.  It is thought this is associated with the up regulation of cytokines and immune modulation seen in COVID.

Mitigation / Suppression:

Most of the world is experiencing a rise in cases:

A new wave of coronavirus infections prompted officials to impose restrictions on some 5 million people in Australia's second-largest city, illustrating the difficulty of conquering the pandemic even in a country that had enjoyed relative success in taming its toll.

Israel reimposes restrictions after COVID-19 spike: Israel on Monday reimposed a series of restrictions to fight a spike in coronavirus infections, including the immediate closure of bars, gyms and event halls. A government announcement said that in addition to the immediate shuttering of bars, night clubs, gyms, event halls and cultural events, the number of diners in restaurants would be limited to 20 indoors and 30 outdoors.

FDA Issued Emergency Use Authorization for Point of Care Antigen Test: The US Food and Drug Administration issued an Emergency Use Authorization (EUA) for a COVID-19 antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2. This is the second antigen test the FDA has authorized for the detection of SARS-CoV-2 antigens. This test is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for high, moderate, or waived complexity testing, meaning it can be used in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Emergency use of this test is limited to authorized laboratories using the BD Veritor Plus Analyzer Instrument. (FDA, 7/6/20)

Corporate

DHS, DOT, and HHS Issue New Guidance for Airline Industry Partners to Facilitate Safe Air Travel: The US Departments of Homeland Security, Transportation, and Health and Human Services today issued joint guidance specifically for the air travel industry to better protect passengers, crew, and other airport workers from the COVID-19 pandemic during our economic recovery. This guidance, the “Runway to Recovery: The United States Framework for Airlines and Airports to Mitigate the Public Health Risks of Coronavirus,” lays out a framework for implementing public health measures in the aviation sector to minimize the risk of COVID-19 transmission. (DHS, 7/2/20)

The Work From Home WorkSTEPS Medical Team:

Ben Hoffman, MD, MPH
Chief Medical Officer

Tony Nigliazzo, MD
Medical Director

Loraine Kanyare, MSN, MPH, RN
Director of Case Management

Robert L. Levitin, MD
Physician Consultant

Lynda Phillips, LVN
Nurse Case Manager

Codey Church, LVN
Nurse Case Manager

Kerry Womack, LVN
Nurse Case Manager

Chuck Reynolds
Strategic Communications Consultant

This Guidance (“Guidance”) is provided for informational and educational purposes only. It is not intended as Legal Advice or Medical Advice. Adherence to any recommendations included in this Guidance will not ensure successful diagnosis or treatment in every situation. Furthermore, the recommendations contained in this Guidance should not be interpreted as setting a standard of care or be deemed inclusive of all proper methods of care nor exclusive of other methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific therapy must be made by the physician and the patient in light of all the circumstances presented by the individual patient, and the known variability and biological behavior of the medical condition. Similarly, this Guidance is based on current advice, comments, and guidance from the EEOC, CDC and the CMS made publicly available. The ultimate judgement regarding the propriety of any specific employment action must be made by the company and attorney in light of all of the circumstances presented by the company, state and federal rules existing at the time and the then current state of the National Pandemic. This Guidance and its conclusions and recommendations reflect the best available information at the time the Guidance was prepared. The results of future studies or changes in rules, regulations or laws may require revisions to the recommendations in this Guidance to reflect new data. WorkSTEPS does not warrant the accuracy or completeness of the Guidance and assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of this Guidance or for any errors or omissions.

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