Update from the Chair

March 25, 2020

Dear Members of the Pathology and Laboratory Medicine Community,

1. Stay Home if Sick
The most important message for today, and the coming days and weeks, is as follows: if you are sick, PLEASE DO NOT come to work. We are already experiencing the consequences of this behavior on some of our clinical services.

You may think you are helping the team by coming to work with a slight fever or cough. However, if you are Covid-positive, simply by showing up at work you take out the whole team of people working with you. This can cripple our ability to provide lifesaving clinical services.

So please take this message to heart, and pass it along to your coworkers: if you feel sick, call your supervisor and stay home. Our Dean Jameson, along with six other Medical School Deans, emphasized this in a New York Times op-ed article as well:  

"Physical separation is the best way to slow the spread. The fewer contacts, and the greater distance between people, the better. That’s why nonessential businesses need to be closed, especially in outbreak areas. This virus is spread person to person and it spreads explosively."

2. Update on our Testing Capabilities for SARS-CoV-2
We continue to send non-emergent tests to outside reference laboratories, with a several-day turnaround time. Our in-house testing capabilities, for rapid turnaround testing, have been expanded. We ran 70 tests yesterday, and our capacity can now handle 100-120/day. Our biggest issue is supply chain, and to get around this problem we are now using several in house platforms. We are running on the Genmark platform, but reagents are limited. We are also up and running with the CDC assay and we are asking research labs to donate supplies to help us keep this assay going. With adequate supply of reagents, this assay could scale to 200-250 tests per day. We have the Roche COBAS platform, but reagents are being diverted by the CDC to hot spots and big reference labs. We are pending on the Cepheid rapid test and we have equipment. We are working now to secure a supply of test reagent kits. We are also pursuing Hologic, Thermo Fisher, and BDmax platforms. Expect BDmax to come online soon in the lab.

3. Serologic Testing for Antibodies to SARS-CoV-2
There has been a lot of discussion in our professional circles about the status of serological testing for antibodies to SARS-CoV-2 and whether there is value to use them in the current situation. A number of companies are currently marketing tests for measuring antibodies to SARS-CoV-2, so here are some of the salient points from these discussions, put together by our Director of Laboratory Medicine, Dr. Irving Nachamkin: 

    - Serologic testing is coming up frequently, especially as more and more manufacturers are developing rapid ‘point of care’ tests; there are no guidelines/recommendations from any group on utility of serologic testing.
    - Studies from China suggest that most patients seroconvert (both IgM and IgG) anywhere from 8 to 11 days post-symptom onset, consistent with most other seroconversion timelines. Given this timeline, the idea that a serologic test can be used at the point-of-care to diagnose or rule-out acutely symptomatic patients is wrong.
    - The performance characteristics of the currently available commercial serologic assays have not been established (i.e. sensitivity, specificity, predictive values). Some data does indicate good specificity, with little cross-reactivity to other viruses.

Potential uses of serology for COVID19, once performance data and clinical correlation can be firmly established, include:

    - Determining immune status. Note that protective levels of antibodies (if antibodies are indeed protective) have not yet been established.
    - Seroepidemiology for community tracking

At this time, we are waiting until there is clear guidance from CDC about whether antibody tests are useful at all in managing the ongoing outbreak and under what circumstances

Whether the FDA provides approval doesn’t mean the test is safe and effective; it only means the test is equivalent to another test on the market (510K process). Researchers at Penn are going to start a study to look at serological testing and we will wait for those studies to inform the utility of serologic testing. Note, however, that there is no evidence yet for this as a diagnostic test and using it for decision making may cause more harm than good.

4. Research Update
Many of our researchers, inside and outside the Department, are accelerating their efforts to combat the pandemic. As our Executive Vice Dean and Chief Scientific Officer Dr. Jon Epstein states: "In a matter of days, the new Penn Center for Research on Coronavirus and Other Emerging Pathogens was created to expand and accelerate SARS-CoV-2 research at Penn, CHOP, and Wistar. We are currently screening libraries of FDA approved drugs for activity against coronaviruses and starting multiple clinical trials. Vaccines are being explored in various labs. Colleagues at the Center for Health Care Innovation are developing designs to automate and facilitate reach to patients who cannot rely on traditional methods of communication." 

5. Coping with Isolation
Many of us are in isolation, working from home. Anne McClain, an astronaut and Army Lieutenant Colonel with significant experience on the International Space Station, provides some useful tips on living in confined spaces for long periods of time.

I also encourage you to make good use of the resources available at Wellness at Penn. We are fortunate to be part of a community that values a shared campus-wide culture of well-being, and that seeks to strengthen ourselves as individuals and as a community by opening ourselves up to our vulnerabilities and to what makes us human.

Please continue to take care of yourselves and each other. The better we take care of ourselves, the more we can help our patients.

David Roth
Chair, Pathology & Laboratory Medicine