There have been few greater challenges for diagnostic laboratories than those presented by COVID-19. For nearly a year, labs have been working around-the-clock to meet unprecedented demand, with the U.S. alone churning through upward of one million COVID-19 tests daily. Many of the labs responsible for this critical work didn’t even have the capabilities for it one year ago. Those of us in the industry have heard countless tales of labs shifting focus, bringing in new equipment, hiring droves of new staff members and in some cases, starting wholly new operations from the ground-up to meet local needs.
Along the way, there have understandably been significant obstacles. However, if there are any silver linings to be found in the era of COVID-19, it is that the lessons learned along the way will work toward preventing a pandemic of this scale in the future.
Adjusting to Rapid Change: Renewed Importance of Diagnostics
As with any crisis, COVID-19 has proven that every second matters when it comes to a response. When SARS-CoV-2 first emerged in late 2019 and early 2020, diagnostic companies mobilized quickly to understand the virus and develop tests to detect it. Naturally, the scientific community first turned toward existing diagnostic tools to help identify the virus. RT-PCR assays proved to be superior in this effort early on, and one year later, they remain the gold standard in COVID-19 testing. This is a direct result of their sensitivity and reliability – two factors that enable labs to accurately and efficiently identify individuals infected with SARS-CoV-2 and help prevent its spread. Two other promising areas in the field of diagnostics that took hold over the last year are sample pooling and minimally invasive tests.
Sample pooling has garnered attention for making large-scale testing efforts possible. In most cases, the RT-PCR assays that support sample pooling allow labs to combine specimens – sometimes from up to five individuals – and conserve other precious resources involved in sample collection. Particularly for major employers, colleges and universities or any other organization looking to test hundreds or thousands of people on a regular basis, sample pooling will play a pivotal role in their reopening and virus prevention strategies. It should be noted, however, that there are limitations to sample pooling – though many are avoidable with more sensitive assays, or those that maintain a lower limit of detection. With continued improvement in this area of diagnostics development, sample pooling is likely to become more prevalent for monitoring diseases above and beyond COVID-19.
Another promising area in diagnostics spurred by COVID-19 has been in developing assays that allow for alternative sample types, such as saliva specimens. Minimally invasive tests like these make sample collection easier and safer, while enhancing comfort levels for the individuals being tested too. The FDA has granted Emergency Use Authorization for several of these assays, with many more also approved for use in European countries that accept the CE mark.
Amid the race to distribute and administer vaccines globally, diagnostic testing and molecular surveillance will continue to be greatly important in tracking COVID-19. In fact, one group of researchers has suggested that diagnostic labs help guide decisions about COVID-19 therapies and the follow-up determination of therapy success (source). For that reason, efforts to further enhance test reliability and sensitivity can and should remain a priority.
Global Collaboration: The Moral Imperative to Fighting COVID-19
In addition to the importance of ongoing testing efforts, COVID-19 has shown the imperative of collaboration in the global scientific community, particularly in combatting highly infectious diseases. Few would disagree in calling it a moral imperative that researchers, healthcare providers and other essential businesses act as a united front in the global pandemic response. Diagnostic labs are the backbone of cross-industry, cross-functional coalitions that have come together for this purpose.
In the last several months, society has seen major companies pledge to work together to develop the world’s first COVID-19 vaccines. Big pharma and biotech firms are working closely in the interest of scientific progress and upholding standards of excellence. The partnership between BioNTech SE and Pfizer has resulted in the first COVID-19 vaccine to receive FDA emergency use authorization. The BioNTech-Pfizer vaccine is also the first to be listed by the World Health Organization for emergency use in nations without their own regulatory bodies, meaning more developing countries will soon be on their way to launch vaccination programs of their own. None of this would be possible without the contributions from laboratory staff involved in the international work leading to these approvals.
Other collaborative efforts in the scientific community have centered around information sharing, which helps ensure the abundance of data around testing kits and therapeutics for everyone and everywhere. In July 2020, PerkinElmer got involved in this effort by launching two online COVID-19 dashboards to make drug compound and clinical trial data publicly available.
Like many things in 2020, the level of collaboration in the scientific community was unprecedented. Society stands to benefit greatly if it continues moving forward.
Automation: Harnessing Technology to Fuel Continued Innovation
Finally, since its earliest applications, automation has played an important role in diagnostic laboratories. In 2020, automation helped lab staff keep pace with testing demands and will undoubtedly be a critical aspect of operations moving forward.
Apart from being highly repetitive, most lab procedures performed manually are arduous, error-prone and could vary greatly from individual-to-individual or run-to-run. To avoid these issues, many labs have turned to self-contained, fully automated instruments and workflows in order to increase throughput and minimize manual labor. Beaumont Health in Michigan, for example, is one such organization that has undertaken a large-scale serology testing program for COVID-19.
With the goal of discovering how many individuals across the health system had developed antibodies for SARS-CoV-2, in April 2020 the Beaumont Research Institute acquired EUROIMMUN Anti-SARS-CoV-2 ELISA testing kits and two EUROLab Workstations to process them. Each workstation allows for fully automated processing (i.e., from primary sample to result) and is capable of processing up to 200 tests per hour. By November, Beaumont had collected and analyzed tests from over 20,600 health care workers and published its findings in Clinical Infectious Diseases. Beyond further substantiating the effectiveness of wearing a mask to prevent SARS-CoV-2 infection – insights that are greatly valuable from a public health education and awareness standpoint – the amount of data this study was able to yield simply would not have been possible without automation underpinnings.
Moving forward, automation software will continue to be just as essential. In the same example of Beaumont Health, electronic questionnaires and consent forms, centralized data hubs and processes that move and store data within a laboratory information system helped to expedite the study. The enormous amount of data generated by testing programs such as this one would otherwise overwhelm labs without the power of automation.
In the coming years – and with continued advances in artificial intelligence and machine learning –automation will help generate insights that help researchers better understand how disease develops in the human body and how it spreads. Laboratories that track these developments and continue to thoughtfully integrate automation into their operations are those that will continue to thrive.
Confronting Challenges that Lie Ahead
With news of a new SARS-CoV-2 strain spreading across the world, if anything is certain about 2021, it is that unforeseen challenges will arise. Most pressing among them is how we track mutations of the novel coronavirus and the next “virus X.” In the coming years, we can expect the shift toward molecular testing and surveillance to continue – hoping to identify and prevent the spread of another infectious disease on this scale. Continued improvement in the area of diagnostics and collaboration in the life sciences and lab communities will help make that possible.
Another top concern for lab leaders should be the talent funnel. Despite being in high-demand, universities are not graduating students at a rate that can keep pace with job openings. Fewer candidates coupled with an aging workforce will remain a challenge. Furthermore, testing demand shows no sign of slowing. In the interim while developing strategies to attract and retain skilled individuals for these jobs, labs may be able to leverage automation to meet current demands—in essence, allowing them to do more with less.
While we hope to never encounter a pandemic like this one again, the lessons that diagnostic labs have learned along the way have been valuable ones.
About the Author:
Arvind Kothandaraman is the General Manager of Specialty Diagnostics at PerkinElmer.