A 3D-printed nasal swab works like a commercial swab for the COVID-19 diagnostic test and was discovered in research-ScienceDaily

A multi-site clinical trial led by the University of South Florida Health (USF Health) Morsani Medical College and its major hospital affiliate, Tampa General Hospital (TGH), makes 3D-printed alternative nasal swabs function similarly safe. The first evidence was obtained, as a standard synthetic flocked nasal swab.

Results were announced online on September 10th Clinical infections.. The commentary that accompanies the paper cites the author’s timely and collaborative response to supply chain disruptions that affect test capabilities early in the pandemic.

USF health researchers in the Department of Radiology and Infectious Diseases contacted TGH colleagues in search of solutions to the unprecedented demand for nasal swabs at their facilities and other institutions. Northwell Health, New York’s largest healthcare provider. And Formlabs, a leading 3D printer maker. The interdisciplinary team quickly designed, tested, and manufactured 3D-printed nasal swab prototypes as an alternative to over-the-counter swarming nasal swabs 24 hours a day. Bench test using respiratory syncytial virus as a proxy for SARS-CoV-2 (24 hours, 3 days, leaching), and local clinical validation of final prototype (manufactured from FDA-approved non-toxic surgical grade material), Completed successfully in mid-March 2020.

Larger clinical trials began in March at three sites, TGH, Northwell Health, and Philadelphia-based Thomas Jefferson University Hospital. (Other sites joined later.)

USF Health held an interim patent on the concept and design of the new 3D printed swab, but was free to share information with hospitals, clinics, governments and international organizations that lacked a supply chain. It was. Since the first batch of 3D-printed cotton swabs have been processed, tens of millions of USF Health-invented devices have been used in 22 countries, said Dr. Summerdecker, associate professor of radiology at USF Health Morsani Medical College. Says. Dr. Decker leads the USF Health Radiology-TGH Division of 3D Clinical Applications, a group of experts in creating and printing 3D anatomical models and designing medical devices for surgeons and other clinicians.

“In the midst of a pandemic, our team of experts representing the scientific medicine, healthcare delivery systems, and medical device industries has set boundaries for rapid collaboration towards a common goal.” Dr. Decker said. “It’s rewarding that the innovative design of the 3D swabs we created has been adopted around the world. We can increase the number of providers that can help diagnose COVID-19 and hopefully prevent its spread. “

The gold standard for diagnosing respiratory infections is to look for the genetic material of the virus in the mucosal fluid collected with an elongated cotton swab inserted into the back of the patient’s nose and throat. Nasal swabs are placed in plastic tubes containing chemicals that stabilize the sample until the virus-specific genetic material is extracted and amplified by the polymerase chain reaction (PCR) in the diagnostic laboratory. Traditional cotton swabs feature a bushy tip coated with nylon flock. USF Health Doctors have designed a chip with a 3D printed texture pattern that can capture enough samples for COVID testing, with patient safety and comfort in mind.

The clinical trial fully tested the safety and efficacy of this 3D printed swab in 291 symptomatic adults undergoing COVID-19 screening at TGV, Northwell Health, and Thomas Jefferson University Hospital. A 3D-printed nasal swab was compared to a standard synthetic nasal swab across three FDA-approved SARS-CoV-2 test platforms for emergency use-real-time reverse transcription PCR at the Center for Disease Control and Prevention. A modified version of the diagnostic panel, and two commercial molecular diagnostic tests.

“This trial provided the first rigorous comparison to confirm that 3D swabs behave like standards,” said Kami Kim, MD, professor and director of infectious diseases at USF Health Morsani College. Said. medicine. “All three platforms used in our study showed that commercial and 3D-printed swabs were equivalent for accurate detection of COVID-19 infection.”

For both swabs, the only patient adverse reactions recorded during the study were some cases of slight epistaxis. The cost of materials per 3D-printed nasal swab ranges from 26 to 46 cents, and commercial swabs each cost about $ 1. The authors report.

Given the ongoing need for extensive COVID-19 testing, the study authors, especially local hospitals or other clinical facilities, have already processed prints and devices.

Dr. Francribiki, MD, Vice-Chair of Operations and Quality, Department of Radiology, University of Cincinnati School of Medicine, wrote a commentary on 3D printing in medicine. Clinical infections paper. This article is by Decker et. al. In the context of a larger 3D manufacturing community.

“Of all the 3D-printed parts during COVID-19, the nasopharyngeal swab was the most noticeable, with participants ranging from humanitarian to Sharattan,” Dr. Ribiki wrote in his summary. I will. “The authors stay on the right side of the curve and appreciate patience, leadership, scientific rigor, and goodwill.”