BIDMC-led clinical trial identifies four novel 3D-printed swabs for use in COVID-19 testing

Large-scale production could reduce one obstacle to widespread COVID-19 testing
Beth Israel Lahey Health

Newswise — 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: jsmitche@bidmc.harvard.edu.   

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. For more information, visit www.bidmc.org

BIDMC is part of Beth Israel Lahey Health, a new health care system that brings together academic medical centers and teaching hospitals, community and specialty hospitals, more than 4,000 physicians and 35,000 employees in a shared mission to expand access to great care and advance the science and practice of medicine through groundbreaking research and education.

###

SEE ORIGINAL STUDY




Filters close

Showing results

110 of 3765
21-Oct-2020 11:10 AM EDT
Model Predicts Likelihood of Acute Kidney Injury Requiring Dialysis in Patients with COVID-19
American Society of Nephrology (ASN)

• In a recent study, a new algorithm achieved good performance for predicting which hospitalized patients will develop acute kidney injury requiring dialysis. • Results from the study will be presented online during ASN Kidney Week 2020 Reimagined October 19–October 25.

Released: 23-Oct-2020 4:55 PM EDT
Woman recovering from COVID-19 shares experience as monoclonal antibody clinical trial participant
University of Texas Health Science Center at Houston

When Christina Loville tested positive for the coronavirus, she was terrified. She decided to channel her fear into researching COVID-19 treatments, where she discovered a local clinical trial led by experts at The University of Texas Health Science Center at Houston (UTHealth).

Released: 23-Oct-2020 4:30 PM EDT
"Third spike" in COVID-19 cases, plus the vaccine trials: Live Expert Panel for October 29, 3PM EDT
Newswise

"Third spike" in COVID-19 cases, plus the vaccine trials: Live Expert Panel for October 29, 3PM EDT

Released: 23-Oct-2020 1:50 PM EDT
Are we really “rounding the corner" when it comes the coronavirus pandemic?
Newswise

“We’re rounding the turn,” Trump said during the debate. This implies a meaningful improvement. We rate this claim as false. On that very same day the U.S. recorded 77,000 new cases, according to NBC News. This tops the previous high that had been set in July. We may be learning to "live with it," as Trump mentioned, but this is not an improvement.

Newswise: 246719_web.jpg
Released: 23-Oct-2020 12:50 PM EDT
NRL researchers evaluate ultraviolet sources, combat COVID-19
United States Naval Research Laboratory

U.S. Naval Research Laboratory researchers evaluated commercial ultraviolet (UV) sources for viral disinfection to combat COVID-19 on land and at sea, and established a dedicated UV characterization lab in five days to ensure safe introduction and effective operation of UV sources across the Fleet.

Released: 23-Oct-2020 12:05 PM EDT
COVID-19 anxiety linked to body image issues
Anglia Ruskin University

A new study has found that anxiety and stress directly linked to COVID-19 could be causing a number of body image issues amongst women and men.

Newswise: 246747_web.jpg
Released: 23-Oct-2020 11:45 AM EDT
Eliminating COVID-19: What the world can learn from NZ and Taiwan
University of Otago

Both Taiwan and New Zealand have successfully eliminated COVID-19 with world-leading pandemic responses. By taking a particularly proactive approach, Taiwan's response was probably the most effective and least disruptive of any country's, researchers say.

Released: 23-Oct-2020 11:00 AM EDT
Healthcare's earthquake: Lessons from COVID-19
Beth Israel Deaconess Medical Center

The COVID-19 pandemic has fundamentally disrupted U.S. healthcare organizations.

Released: 23-Oct-2020 10:50 AM EDT
COVID-19 lockdown reduced mental health, sleep, exercise
Pennington Biomedical Research Center

A first-of-its-kind global survey shows the initial phase of the COVID-19 lockdown dramatically altered our personal habits, largely for the worse.


Showing results

110 of 3765

close
1.65905