The Benefits (and Risks) of a Comprehensive Diagnostic Approach

April 1, 2021

Image of the cover of Microcosm Magazine's Spring 2021 issue.

From the Spring 2021 issue of "Microcosm."

Even as society continues to reckon with COVID-19, scientists and public health officials are already taking steps to prevent the next outbreak. Such measures will utilize diagnostic techniques that rely upon the robust, coordinated surveillance of individuals, communities, populations and environments, a concept known as "One Health." Yet when considering the development and implementation of novel diagnostic technology with such large societal impact, the research community must take into account the potential implications and inherent trade-offs that accompany innovation in order to ensure that scientific solutions are moral and equitable and minimize risk.

A researcher observes grazing cattle.

One Health "recognizes that the health of people is closely connected to the health of animals and our shared environment." Or as Dr. Sanjana Mukherjee, an ORISE Public Health Policy and Regulatory Research Fellow at the Food and Drug Administration (FDA), puts it, "People are really figuring out that you won't be able to solve a [health] crisis by just focusing on humans." Instead, the approach promoted by One Health involves close monitoring of animal populations, intense research into the behavior of plants, fungi and other microorganisms, and studying (and minimizing) the impact of environmental changes, all while improving current diagnostic tools used to prevent disease in humans.

"There is a clear need for simple, rapid, point-of-care diagnostics in the field or at home," says Dr. Changchun Liu, associate professor of Biomedical Engineering at the University of Connecticut. That's why, according to Dr. Liu, "the smartphone is the ideal tool for pathogen detection." His team is utilizing the ubiquity, computing power and high-resolution imaging capacity of mobile devices to develop straightforward diagnostic applications that can aid both patients and medical professionals.

Other novel diagnostic approaches seemingly come straight out of science fiction. A glowing liquid that indicates the presence of pathogens? Researchers in Germany have developed a technique in which carbon nanotubes fluoresce upon coming in contact with molecules emitted by certain bacteria, eliminating the need for costly analysis of tissue samples. Particle-sized mechanical sensors released into the atmosphere capable of monitoring minute changes in environmental conditions over large geographic areas? That's the concept behind smart dust (also known as "motes"), which researchers propose deploying in a variety of facets, including crop monitoring and the observation of animal habitats.

More Traditional Tools and Techniques Are Being Reimagined and Adapted for New Purposes as Well

A researcher collects wastewater samples for analysis.

Wastewater analysis has been used for decades to monitor the presence and environmental impact of pharmaceutical products, as well as to detect illicit drug use. Thanks to COVID-19, the technique has received a renewed focus for its use in disease detection, according to Dr. Wayne Hall, emeritus professor at the National Centre for Youth Substance Use Research in Queensland, Australia. "The idea has been around for a while, it just hasn't really been applied on a wide scale," he says. "I guess COVID has kind of given us a huge kick along." So much so, in fact, that since the beginning of 2020, there have been nearly 300 papers published on the detection of SARS-CoV-2 in wastewater.

Elsewhere, researchers are building off of existing laboratory-based methods, including PCR, CRISPR, DNA microarrays and detection assays such as ELISAs and immunoblots, to develop improved diagnostic tests that have higher sensitivity, increased processing capacity, and the ability to obtain results more quickly. Such advances will allow researchers to better survey, detect and diagnose potential and active threats, leading to faster, more rapid therapeutic interventions.

While promising from a scientific perspective, the comprehensive, all-encompassing nature of the One Health approach does raise uncomfortable questions related to risk, ethics, privacy and legality.

How Can Community Members Be Informed so that They Understand the Issues at Stake with Respect to Widespread Surveillance and Diagnostics?

Do citizens get any input into which measures are enacted by their elected officials? And what can individuals do that would help with these technological solutions while still retaining their rights and voices?

The way Dr. Hall sees things, it is incumbent on scientists to consider these issues before, not after, conducting their research. "It's thinking how might this technology be used, not just for the benefit of the greater good, but how ... uninformed and naive use of this technology [could] harm people," he says. "You can't know that in advance, but it's certainly well worth thinking about as you're developing the methods."

For his part, UConn's Dr. Liu is quick to recognize the potential risks of the smartphone technology his group is developing. The "first thing[s] we need to address," he says, are "the privacy issue and the security issue." Similar concerns have been raised about other technologies: Scholars have argued that the "privacy and environmental risks which follow smart dust far outweigh its benefit."

It all comes down to balance, says Dr. Jeremy Prichard, associate professor in the Faculty of Law at the University of Tasmania. "Appropriate research ethics," he points out, "is about balancing sometimes competing or different considerations. It would be wrong to think that the best way to approach ethics is to avoid risk at all costs — even if that means preventing beneficial research."

Contemplating how to advise researchers to achieve this balance is what led Drs. Hall and Prichard and their colleagues to develop a set of voluntary ethical guidelines around issues related to wastewater analysis. By putting the onus on scientists to understand the impact of their work and communicate with affected populations, the guidelines represent an intriguing model for other fields to consider using.

A proactive approach on the part of scientists to address these issues would have the added benefit of obviating the need for a long, drawn-out push for legislative action. As Dr. Mukherjee points out, the "FDA's regulatory authority is enforced by statutes and laws passed by Congress. And having Congress involved is going to be a super-long process."

Looking to the Future, Preventing the Global Havoc Wrought by Disease Outbreaks Like COVID-19 and Zika Is Paramount

While the scientific research and public health communities will keep moving forward with technological advancements such as One Health, bringing the greater public along presents an equally significant challenge, especially when considering humanity's stupefying ability to ignore intangible threats. "I think, from what we've seen with COVID, people don't really prepare," says Dr. Mukherjee. "I think they're very reactionary."

Lowering the activation energy needed to make society better-prepared requires that scientists promote education and awareness, and engage in dialogue that invites input and feedback from all communities. Doing so will demonstrate that One Health truly is for the benefit of everyone.

*Dr. Sanjana Mukherjee's views are her own and do not represent those of the FDA.

Author: Geoff Hunt, Ph.D.

Geoff Hunt, Ph.D.
Geoff Hunt earned his Ph.D. in molecular biology from Princeton University.