Coronavirus testing: Facing Challenges Outside the Lab

Widespread Coronavirus Testing: Facing Challenges Outside the Lab

— Cristina Deptula

According to Johns Hopkins University’s coronavirus tracking site, clinicians have performed some 20 million coronavirus tests in the United States.

That number may seem impressive until we remember that the working-age population of the country is just over 200 million, and the elderly population, those most at risk of serious complications if they become ill, is 56 million.

Public health experts say far more diagnostic testing is crucial, not only to safely reopen society but for the epidemiological research needed to track and stop the spread of the disease worldwide. In fact, many experts are calling for testing levels at least twice what they are now.

Craig Rouskey is the founder of San Francisco startup Renegade Bio, which claims to have created a significantly cheaper, faster, and easier coronavirus test. Rouskey’s expertise is in molecular biology and the development of diagnostic tests within the laboratory. Yet, even as a lab scientist, familiar with the long road to developing tests and the accuracy issues with some early coronavirus diagnostic tools, Rouskey believes that the biggest obstacles to rolling out widespread testing are factors outside the laboratory.

These hurdles include creating and distributing enough testing supplies and personal protective equipment (PPE) for those who conduct tests, getting accurate information out about testing to different groups of people, training enough clinicians and making the testing centers fully accessible.

Randy Altschuler and Laurence Zuriff co-founded Xometry, a Gaithersburg, MD firm that sources parts for manufacturers. Although Xometry is not directly involved in logistics related to coronavirus testing, they, along with the rest of the world, have had to quickly adapt to broken supply chains during the pandemic.

Altschuler commented on ways we might efficiently source and distribute vast quantities of PPE and testing materials:

“Often, even when large organizations are desperate for supplies, like cotton swabs, it’s hard for them to change their behavior. They don’t, or can’t, adopt creative solutions or always accept donated or innovatively manufactured supplies because that doesn’t meet their needs, or their expectations.”

Altschuler acknowledged the many makers and startups 3-D printing healthcare supplies, but said that it was difficult to rapidly produce large quantities of items that way.

“As much as possible, it makes sense to use already existing infrastructure to produce, store, and ship what we need. Big retail and big restaurant chains are used to handling perishables [such as coronavirus test samples], so let’s shift our tried-and-true systems to facilitating coronavirus tests rather than inventing something new.”

He said we would probably need a government partnership with big retail chains. “Who knows how smoothly that will go, but that’s likely what will have to happen.”

Maria Chavez, president of Bio Curious, a laboratory and meeting space for citizen scientists and entrepreneurs in Santa Clara, CA, echoed the concern about shortages of cotton swabs and other physical supplies for testing.

“It might be up to two years before we get a vaccine,” she said. “So we’re going to need a lot of testing equipment.”

Other researchers and community leaders point to emerging social concerns with widespread testing.

San Francisco news outlets have reported on difficulties in the city’s low-income Tenderloin neighborhood, where testing appointments are required and many residents lack smartphones or computers to make those appointments. Community leaders have provided feedback to testing center administrators about ways to improve community access, such as allowing walk-in testing.

Testing centers will also need to consider the needs of people with disabilities. 

One product designed to promote accessibility is the clear mask. The idea came from hobbyist inventors concerned that existing masks would prevent deaf and hard of hearing people from lip reading. One of these hobbyists, Eastern Kentucky University senior Ashley Lawrence, profiled in Shape magazine in April, just reached her $3000 fundraising goal on Kickstarter and is now donating and shipping the clear masks out to deaf and hard of hearing people. 

Altschuler of Xometry also highlighted clear masks as an example of ideas and products from small startups, hackers and makers inspiring more mainstream outlets to expand or improve their offerings. Although, as he pointed out, we can’t replace large scale manufacturing with a few 3-D printers, small startups, hobbyists, and citizen scientists can play a crucial role in public health by prototyping ways larger firms can enhance their products.

Others have noted that privacy and other civil liberties issues present serious concerns if testing becomes mandatory in society at large or even just in the workplace. Certain populations may prefer not to attract the attention of authorities and many people may not want their social networks exposed through contact tracing.

Stanford University Ph.D. candidate in bioengineering, Rolando Perez, also a board member of Xinampa, a biotech lab and coworking space in the agricultural center of Salinas, CA, echoed many of those concerns.

“We’ve got undocumented farmworkers in Monterey Bay, essential workers, who don’t access regular healthcare because they’re afraid of being deported.”

Perez continued, offering a paradigm shift for testing informed by Xinampa’s philosophy of empowering local populations:

“You put the testing technology in people’s hands so they can test and sequence themselves and track the disease within their own communities. Put the tools in their hands so they don’t have to interface with institutions.”

Bryce Nesbitt of Counter Culture Labs, in Oakland, CA, said that people may also avoid getting tested where it’s voluntary. They may fear losing income or employment if they receive a positive result and need to self-quarantine for 14 days.

“We can work through that by setting up a safety net,” he said, “so that people have paid leave in the event of a positive test.”

Employers can also offer those workers the option, where possible, to continue to work from home.

Nesbitt also reminded us that with voluntary workplace testing, and no social or other pressure to get tested, there’s no guarantee that the workers who volunteer will be the ones most exposed to other people and likely to accidentally infect others.  

The perceptions that tests are not readily available, that only those who are symptomatic can get tested, that people will have to wait in line for hours to get a test, can also discourage people from seeking out testing. So once we can produce and distribute enough tests and equipment to make testing easily available to large segments of the population, we will need to communicate to the public, through various media in many languages, that even healthy people are strongly encouraged to come in for a quick test.

Of course, many public health experts view a ‘hand-held’ kit that people can use at home as the ‘gold standard’ for diagnostic testing. Six firms have recently received FDA clearance for emergency use of their at-home tests. Some observers point out, though, that accuracy may be compromised with a self-administered test. Also, samples still need to be sent to a lab for evaluation, so results are not immediate. And privacy and civil liberties concerns about confidentiality of personal data will still need to be addressed.

As Craig Rouskey of Renegade Bio reminds us, diagnostic testing won’t answer every question we have about the coronavirus – how long the epidemic will last, whether the virus will mutate, how best to treat illness.

Still, though, Rouskey says widespread, frequent testing is vitally important because of the nature of this epidemic.

“With Spanish flu, you tended to catch it and then get better or die relatively quickly. But with corona, you can be infected and spread the disease for a much longer time with absolutely no symptoms. So you’ve got to get tested, for others as much as for yourself.”

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