BIDMC-led clinical trial identifies four novel 3D-printed swabs for use in COVID-19 testing
BIDMC – April 20, 2020
Large-scale production could reduce one obstacle to widespread COVID-19 testing.
Boston, Mass. – Public health experts and government leaders agree that easy access to testing for COVID-19 will be critical to managing the virus’ spread and re-opening the world’s economies. However, 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. Now a clinical trial conducted by a multi-disciplinary team from Beth Israel Deaconess Medical Center (BIDMC), part of Beth Israel Lahey Health, has identified four novel prototypes of 3D-printed swabs that can be used for COVID-19 testing. A preprint of the team’s manuscript is available on medRxiv.org.*
Four swab prototypes developed through a highly collaborative effort coordinated by Ramy Arnaout, MD, DPhil, Associate Director of the Clinical Microbiology Laboratories at BIDMC, were tested against a standard NP swab in 230 adults who underwent testing for COVID-19 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.
“In this study, we describe the first clinical-trial results of our effort to develop and evaluate multiple new swab prototypes on an extremely tight timeline to address a critical shortage brought about by the COVID-19 pandemic,” said Arnaout. “Through the work of a large and selfless team from health care, academia, and the private sector, it took just 22 days from the time we identified the swab shortage to when our trial clinically validated the first new swab capable of high-throughput manufacture.”
The ongoing clinical trial is the third and final step in an effort that began mid-March, when Arnaout and his fellow directors of BIDMC’s Clinical Microbiology Labs – James Kirby, MD, PhD, and Stefan Riedel, MD, PhD – noted impending swab shortages could hamper testing for COVID-19. Arnaout and colleagues soon had more than 150 novel swab designs made of 45 different materials submitted by 23 companies, laboratories and individuals across the country for BIDMC’s consideration.
“To develop novel, effective alternatives as quickly and safely as possible, we and our collaborators modeled our process on scientific studies that have shown that open and collaborative processes outperform closed or proprietary ones when it comes to time-sensitive innovation,” Arnaout said. “We hope our collective experience can provide a useful roadmap to others working under the pressure of a public health emergency.”
The team established 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, which are critical to specimen collection for diagnostic testing for SARS-CoV-2, the virus that causes COVID-19.
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. Additionally, materials comprising the swab must not interfere chemically with the sensitive genetic test, known as a PCR, used to detect the presence of the virus.
In the first stage of evaluation, experts on the front lines of patient care, including infectious disease specialists and respiratory therapists, provided design feedback on more than 100 prototype swabs developed in less than two weeks by the consortium of collaborators from industry and academia, which included Carbon and Resolution Medical; EnvisionTEC; FormLabs; HP; OPT Industries; Origin; Stanford University; the University of South Florida; and the University of Washington.
In the second stage, Arnaout and colleagues at BIDMC considered the swabs’ potential for large-scale production, sterilization, and packaging. The team also considered variations in the supply chains required for each prototype, “to minimize the risk of future single failure points such as those that contributed to this current swab-shortage crisis,” Arnaout added. The third step was the IRB-approved clinical trial for testing promising prototypes on adult patient-volunteers, including prototypes from Carbon/Resolution Medical, EnvisionTEC, HP and Origin.
Critical supply chain challenges still remain with respect to COVID testing, but with the trial results announced today, “we are cautiously optimistic that the availability of swabs will soon no longer be a constraint on widespread COVID-19 testing, thanks to an extraordinarily hard-working, talented, and selfless group, including dozens of people at BIDMC, who came together from all over the country to do this work,” Arnaout said.
“When the virus first emerged, one of the great barriers facing hospitals was the limited availability of testing,” said Gyongyi Szabo, MD, PhD, Chief Academic Officer for Beth Israel Deaconess Medical Center and Beth Israel Lahey Health. “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 the extraordinary challenges of the COVID-19 pandemic.”
Arnaout thanks his team and other collaborators and colleagues, including Abigail Bakken, Craig Broady, John Burpo, Cody Callahan, Alisa Chau, Annie Cheng, Monique Cole, Daniel Davis, Summer Decker, Joseph DeSimone, Zachary Fitts, Annette Friskopp, Ric Fulop, Jonathan Goldie, Grant Michael Gonzalez, Pavel Gorelik, Alex Green, Markus Greiner, Marie Herring, Jenny Hu, Matthew Hurley, Lan Huynh, Don Ingber, Pawan Jolly, Hardik Kabaria, James Kirby, David Lakatos, Rose Lee, Christina Lexinger-Holahan, Ben Linville-Engler, Lorinda Longhi, Ofer Mazor, Restituto Miranda, Goutam Reddy, Stefan Riedel, Karen Robinson, Kit Parker, Oren Mechanic, Richard Novak, Jifei Ou, Michael Papish, Shawn Patterson, Steve Pollack, Chris Prucha, Christian Reed, Isabel Sanz, Adama Sesay, Al Siblani, Kenneth P. Smith, Lihua Zhao and Kate Zulauf.
* Note: The contents of this press release reflect the findings of an updated version of the manuscript submitted to but not yet available on medRxiv.org. The updated manuscript is available upon request. Please contact Jacqueline Mitchell (BIDMC) at: email@example.com.