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9/17/20 COVID-19 Brief: Getting Testing Right – Right Test, Person, Timing and Cost

Testing is a hot topic right now. It’s also a pretty complicated one. So, when we’re asked about testing, we begin with these key points.

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

Getting Testing Right – Right Test, Person, Timing and Cost

Testing is a hot topic right now. It’s also a pretty complicated one. So, when we’re asked about testing, we begin with these key points:

1. Expect guidance to change as disease insights and test technology evolve.

2. At this time, a fast, accurate and affordable (at scale) COVID-19 test does not exist. So it’s not yet feasible to perform regular mass-testing to prevent infected people from entering the workplace.

3. For now, use evidence to focus on specific use cases. Strive to get testing right – the right test for the right person at the right time and the right cost – in order to:

  • Decrease chances an infected employee enters the worksite
  • Reduce unnecessary quarantine time
  • Avoid wasting resources on low-value testing

4. Testing does not eliminate transmission risk, so companies must remain diligent with COVID-19 mitigation and suppression measures, including a focus on ventilation.

Factors that Determine what “Right” Is

Which type of test to use on who and when is determined by a number of factors, including: A) the attributes of the different types of tests; B) suspected timing of infection and symptoms; and C) pretest probability, which – in layman’s terms – refers to the likelihood that a test result is going to be positive or negative.

Guidance Document Available

Because getting testing right is complicated, we’ve created COVID-19 Testing: Guidance for Employers. The document provides information about the different types of tests, reviews the factors mentioned above, and outlines testing recommendations for three different use cases. Notably, we wrote the guidance so that it can be understood by people who are not scientists, so you can use it to educate senior leadership about testing and lay the groundwork for your organization’s testing policies.

Know that we are monitoring information that would change our testing guidance. It is not a matter of “if” but “when” we will issue an update to the guidance document, so stay tuned to this update.

As summer turns to fall, there are lots of COVID-19-related issues popping up. Help us prioritize the topics we cover in this Brief by sharing your thoughts here.

Ben Hoffman, MD, MPH
Chief Medical Officer, WorkSTEPS

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

P.S. – In Case You Missed It – Updated EEOC Guidance

Last week, the EEOC posted an update of COVID-19 guidance for employers, introducing it as follows: “Today, the U.S. Equal Employment Opportunity Commission (EEOC) posted an updated technical assistance document, “What You Should Know About COVID-19 and the ADA, Rehabilitation Act, and Other EEO Laws (WYSK),” which incorporates information from other agency resources and modifies two existing Q&As in order to create a user-friendly comprehensive guide that addresses common questions about COVID-19 and federal equal employment opportunity laws for employers, advocates, and workers.

The update is no doubt worth a careful review as you navigate COVID-19 RTW and other decisions.

WorkSTEPS is hosting a series of informational webinars, each focused on a unique Covid-19 business challenge. Click here for more information and to register for the following:

Medical:


Area Reported Cases Deaths Recovered
Global 29,927,685 942,564 21,685,721
United States 6,802,097 200,770 4,087,090

Source

Globally: Latin America is the current epicenter of the pandemic. The region currently accounts  for almost half of all deaths each day and is fueled by a surge in fatalities in Brazil, Mexico and other countries in the region.

Nationally: As of Tuesday afternoon, more than 6,336,300 people in the U.S had been infected with coronavirus. At least 189,300 had died. Case counts are averaging 40,000 daily which is a decrease considerably since late July when the daily average was 60,000 daily. Iowa has replaced Texas, Florida, and Arizona as the nation’s current hot spot with an almost 11% positive testing rate. The latest White House coronavirus report urged Iowa's Gov. Reynolds to issue a mask mandate and other mitigation processes in the state.

Corticosteroids lower 28-day death rates: Last week, a meta-analysis of the three corticosteroid trials, plus four other such trials, showed that 28-day rates of death from any cause were lower in COVID-19 patients given corticosteroids versus those given a placebo. The study, conducted by the WHO, analyzed data from 1,703 patients. Of 678 total patients randomly assigned to receive corticosteroids, 33% died, compared with 41% who received usual care or placebo. Of the six studies that reported serious adverse events, 18% occurred among those given corticosteroids, while they occurred in 23% of those receiving standard care or placebo. The researchers concluded that a corticosteroid regimen should be utilized for critically ill patients with COVID-19.

The WHO on corticosteroids: The WHO updated its guidance for healthcare providers on the use of corticosteroids in COVID-19 patients. The organization now recommends the use of systemic corticosteroids for treating patients who have severe or critical coronavirus illness but not for those with non-serious disease.

Long term effects: A study (not yet peer reviewed) by researchers at Gladstone Institutes (California, US) identified severe damage to heart tissue due to SARS-CoV-2 infection. The study (preprint) exposed cardiac cells to SARS-CoV-2 in vitro and found that muscle fibers were severed, similar to observations of heart tissue from deceased COVID-19 patients.

‘Carnage’ in a Lab Dish Shows How the Coronavirus May Damage the Heart: Maybe we should think of COVID-19 as a heart disease. When SARS-CoV-2 virus was added to human heart cells grown in lab dishes, the long muscle fibers that keep hearts beating were diced into short bits, alarming scientists at the San Francisco-based Gladstone Institutes, especially after they saw a similar phenomenon in heart tissue from COVID-19 patients’ autopsies.  Their experiments could potentially explain why some people still feel short of breath after their COVID infections clear and add to worries that survivors may be at risk for future heart failure.

Children Can Have COVID-19 Antibodies and Virus in Their System Simultaneously (Medical Xpress): With many questions remaining around how children spread COVID-19, Children's National Hospital researchers set out to improve the understanding of how long it takes pediatric patients with the virus to clear it from their systems, and at what point they start to make antibodies that work against the coronavirus. “With most viruses, when you start to detect antibodies, you won't detect the virus anymore. But with COVID-19, we're seeing both," says Burak Bahar, M.D., lead author of the study and director of Laboratory Informatics at Children's National. "This means children still have the potential to transmit the virus even if antibodies are detected."

One of every 10 pregnant or recently pregnant women in hospital was diagnosed with COVID-19, yet up to three-quarters were asymptomatic at the time of diagnosis, according to a living systematic review from the PregCOV-19 Living Systematic Review Consortium. The study, published in BMJ, shows an increased risk of preterm delivery, as well as the need for invasive ventilation in these women, wrote John Allotey, PhD, of the University of Birmingham (England) and colleagues. The findings "will produce a strong evidence base for living guidelines on COVID-19 and pregnancy," they noted.

Mitigation / Suppression:

Biopharma pledge:  CEO’s of nine pharmaceutical companies signed a joint pledge of their commitment to developing and testing potential vaccines rigorously. They all pledged they would submit a vaccine candidate for approval or  EUA authorization only after demonstrating safety and efficacy through a Phase 3 clinical study to meet requirements of regulatory bodies such as the FDA.

AstraZeneca Oxford vaccine trial halted: AstraZeneca - Oxford coronavirus vaccine, (AZD1222) has been placed on temporary pause across all trials to allow an independent committee to review the safety data after an event of an unexplained illness occurred in the UK Phase III trial. AstraZeneca announced that the independent review committee will review the event as a part of their routine safety protocol and the committee will guide them as to when the trials could restart. Temporary halts in medical studies are not uncommon. Two other vaccines are in phase III testing in the United States. One is by Moderna and the other by Pfizer and Germany’s BioNTech.

Widespread COVID-19 Vaccinations Not Expected Until Mid-2021, WHO Says (Reuters): The World Health Organization does not expect widespread vaccinations against COVID-19 until the middle of next year, a spokeswoman said on Friday, stressing the importance of rigorous checks on their effectiveness and safety. None of the candidate vaccines in advanced clinical trials so far has demonstrated a “clear signal” of efficacy at the level of at least 50% sought by the WHO, spokeswoman Margaret Harris said.

NIH Continues to Boost National COVID-19 Testing Capacity (NIH): The National Institutes of Health announced $129.3 million in scale-up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can return results within 24 hours. These tests add to initial awards made to seven companies on July 31, 2020.

Corporate:

CDC Tells States How to Prepare for COVID-19 Vaccine by Early November: The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November. The new CDC guidance is the latest sign of an accelerating race for a vaccine to ease a pandemic that has killed more than 184,000 Americans. The documents were sent out on the same day that President Trump told the nation in his speech to the Republican National Convention that a vaccine might arrive before the end of the year.

What Is the Risk of Catching the Coronavirus on a Plane?

Experts stress the importance of getting a flu vaccination: On Tuesday, the American Academy of Pediatrics put out its 2020-21 recommendations on preventing influenza. Experts are emphasizing that the flu vaccine is more important this flu season than ever given the continued transmission of COVID-19 and the possibility of hospitals becoming overburdened. The recommendations emphasize that everyone over 6 months of age, including pregnant women, should be immunized, ideally by the end of October.

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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