黑料正能量

By: Sachin Waikar
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鈥淗ave I been exposed to the coronavirus?鈥�

That was the question on most everyone鈥檚 mind in the early days of the COVID-19 crisis, as media reports of rising exposure, symptom, and fatality rates proliferated. But with minimal testing available, few people could secure a definitive answer to the question, contributing to widespread fear and uncertainty.

Eugene McMahon 鈥�02, set out to address the problem at , where he is the chief medical officer. Capital Health runs two New Jersey hospitals, including one in the state capital of Trenton; the system has about 500 beds and 4,000 employees.

Specifically, in late April 2020, McMahon and fellow leaders to test a large percentage of Capital Health employees, ultimately about 2,400 in all. 鈥淭he early coronavirus situation was upending for everyone here,鈥� McMahon says. 鈥淪o we wanted to see if we could identify a reasonable method for testing for antibodies that presumptively will confer immunity.鈥�

The case for testing

In the case of the novel coronavirus, that means testing people for the presence of immunoglobulin G, or IgG, the antibody that helps people fight the virus. While nasal swabs and other techniques test for the presence of the virus itself, IgG testing indicates antibodies 鈥� suggesting previous exposure to the virus.

Why does such testing matter?

Like much of the medical community, McMahon鈥檚 hunch was that many people will be exposed to the virus and develop antibodies and immunity without ever having significant or even noticeable symptoms. So testing is important to get a handle on what percentage of a given population has been exposed to the novel coronavirus or already has immunity.

鈥淲hen this started we were seeing estimates all over the place of how many people were going to die from this,鈥� McMahon says. 鈥淲e didn鈥檛 have a good fix on how many people had really been exposed because we only saw the very, very sick coming in to emergency departments. Testing gives us a better sense of the true denominator.鈥�

Moreover, establishing a reliable antibody test has been challenging. McMahon says, 鈥淪ome of the tests are manufactured outside the U.S. and the quality standards aren鈥檛 what we鈥檇 expect.鈥�

The company produced the designs in-house then scaled up production, using their Chicago-based factory for 3D printing where possible, then transitioned to traditional, less expensive manufacturing methods such as injection molding to handle larger volumes. 鈥淚t鈥檚 a very agile way of working,鈥� Nanry says.

Finally, antibody testing gives those who test positive some peace of mind about their status. They may be less concerned about contracting or spreading disease, for example.

To make antibody testing at Capital Health a reality, McMahon had to find a reliable manufacturer of IgG-antibody testing kits. His search led him to Epitope Diagnostics, a San Diego-area biotechnology business. They offer ELISA-based testing products, which examine blood serum for the presence of specific antibodies. McMahon was eager to work with them partly because they have a partnership with a China-based university, in the country where the virus was first identified. 鈥淪o they had access to true-positive patients鈥� specimens to develop their test,鈥� he says.

With a reliable test in hand, McMahon鈥檚 team started by testing the hospital鈥檚 frontline workers, rather than those farther removed from patient care. 鈥淲e had people exhausted and going home in tears, worried they were going to bring something unmanageable home to their family,鈥� he says. 鈥淲e wanted to be able to tell them if they had the antibody in their system.鈥�

Among the lessons learned from the company鈥檚 COVID-focused efforts has been the speed and agility with which manufacturing players and the broader supply chain have moved in the face of the crisis.

What the testing revealed

Testing revealed the presence of antibodies in about 7% of the 2,400 Capital Health employees in the study. Another 3% were found to be in a 鈥済ray area,鈥� as McMahon called it: 鈥淚t鈥檚 borderline but we鈥檙e not comfortable calling it positive.鈥� That leaves about 90% of employees testing negative for antibodies 鈥� suggesting no exposure to the virus.

Importantly, about one-third of those testing positive had no symptoms, and another 20% had only mild symptoms. 鈥淭hey had no idea they had been sick or when they thought about it realized maybe several weeks prior they had what they thought was a head cold or a little cough,鈥� McMahon says.

Moreover, the rate of positive results grew over time, with a higher percentage of people 鈥� about 10%-11% 鈥� showing presence of antibodies in the third week of testing versus the first. 鈥淭hat tells us that exposure to the virus is growing over time,鈥� McMahon says.

One of the benefits of the testing, as hoped, has been greater peace of mind among Capital Health employees. McMahon says, 鈥淜nowing they test positive helps them sleep at night鈥� because there鈥檚 less concern about contracting disease or exposing others.

At the same time, McMahon and other Capital Health Leaders aren鈥檛 using the test results to make staffing or other operational decisions. He says, 鈥淲e don鈥檛 share the testing information with HR or corporate.鈥�

The results also have epidemiological implications. For example, McMahon believes the 7% figure may provide a good estimate for rates of exposure in densely populated urban environments like New York City, which has millions of citizens. 鈥淭he vast majority of people exposed don鈥檛 even know it,鈥� he says.

On one hand, that means asymptomatic people are likely transmitting the virus, as many sources have suggested. On the other, it implies that the true COVID fatality rate may be significantly lower than currently estimated, as there are many more cases to date than those confirmed by tests indicate.

McMahon is now seeking approval to run antibody testing in area nursing homes, again to provide clarity and peace of mind. In closing, he says, 鈥淲e wanted to both invest in our employees鈥� wellbeing and learn some information to get a better grip on things amidst all the chaos.鈥�

The testing he oversaw at Capital Health has clearly achieved this goal, with wide-ranging benefits for multiple populations.