Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, has completed a clinical trial that identified four novel prototypes of 3D-printed swabs that can be used for COVID-19 testing. An important step to overcome a shortage of specialized nasopharyngeal (NP) swabs used to collect samples from patients’ noses and throats for diagnosis is one of several bottlenecks in the way of widespread testing. And ultimately, public health experts and government leaders agree that easy access to testing for COVID-19 will be critical to managing the virus’ spread reopening the world’s economies. BIDMC’s study, leveraging collaboration and advanced technologies, moves the ball forward.
The study, published recently in the preprint server medRxiv, was the result of a highly collaborative effort coordinated by Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories at BIDMC. The four swab prototypes developed were tested against a standard NP swab in 230 adults who underwent testing for COVID-119 at BIDMC and volunteered to participate in the study. The four swabs—selected after the review of more than 100 designs—showed excellent concordance with the controls in a clinical trial, reports Jaqueline Mitchell with BIDMC News.
Among the design considerations was the importance of the roughly six-inch swabs being rigid enough to reach potentially infected cells at the back of the nasopharynx, but flexible enough not to damage soft and sensitive tissues along the way. Moreover, materials comprising the swab can’t interfere chemically with the sensitive genetic test, known as a PCR, used to detect the presence of COVID-19.
The team went through a multi-stage, interactive design process involving experts on the front lines of patient care (e.g. infectious disease specialists and respiratory therapists) who provided design feedback on more than 100 prototype swabs developed in less than two weeks by the consortium of collaborators from the industry and academia, which included Carbon and Resolution Medical; EnvisionTEC; FormLabs; OPT Industries; Origin; Stanford University; the University of South Florida; and the University of Washington. By the second stage of the effort, the BIDMC team considered the swabs’ potential for large-scale production, sterilization and packaging. Other factors required thought such as variations in the supply chains required for each prototype “to minimize the risk of future single failure points such as those that contributed to the current swab-shortage crisis,” reported Dr. Arnaout. In the third stage, the team needed to secure IRB approval for a clinical trial to test the prototypes on adult patient-volunteers, including the prototypes from Carbon/Resolution Medical, EnvisionTEC, HP and Origin.
With clinical trial results out, the team conveyed cautious optimism with the goal that the availability of swabs soon wouldn’t be a challenge in the way of pervasive and systematic COVID-19 testing. However, critical supply chain challenges still remain with respect to more broad-based testing efforts. But the teams are closer.
The study was based on a three-part protocol to evaluate newly-designed prototypes from third parties, as well as existing medical swabs that could be repurposed, to serve as a substitute for standard NP swabs. These products components are critical to specimen collection for diagnostic testing for SARS-CoV-2, the virus that causes COVID-19. The ongoing clinical trial, in its third and final step,
The Power of Collaboration
In touting the power of cooperation and shared pursuits, Gyongi Szabo, MD, PhD, Chief Academic Officer for Beth Israel Deaconess Medical Center and Beth Israel Lahey Health, noted, “BIDMC’s mission as an academic medical center includes to bring innovation from our laboratories to the bedside. This effort demonstrates the power of successful collaboration among BIDMC, academic and industry partners to respond to extraordinary challenges of the COVID-19 pandemic.”
Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories at BIDMC
Note, other authors are involved and can be seen in the source document.