In the video above, USF Health leaders and frontline workers look back on the successes, challenges and emotions they experienced while dealing with an incredibly challenging year amid the COVID-19 pandemic. Their stories include developing testing supplies now used around the world, creating programs aimed at treating vulnerable populations and helping rapidly develop and roll out vaccines against the disease, which Dr. Charles Lockwood, MD, Dean of the USF Health Morsani College of Medicine said “rivals the moon landing.”

USF Health College of Nursing vice dean Denise Maguire, PhD, administers a vaccine shot.

The device invented by USF Health doctors, teaming with Tampa General Hospital, Northwell Health and Formlabs, has been used worldwide to address critical shortages of test kit swabs

Tens of millions of the USF Health-invented 3D printed nasal swabs have been mass produced for use by health care providers worldwide. [Allison Long, USF Health Communications]

Now, a multisite clinical trial led by the University of South Florida Health (USF Health) Morsani College of Medicine provides the first evidence that 3D-printed alternative nasal swabs work as well, and safely, as the standard synthetic flocked nasal swabs.

The results were published online Sept. 10 in Clinical Infectious Diseases. A commentary accompanying the paper cites the authors’ timely, collaborative response to supply chain disruptions affecting testing capacity early in the pandemic.

Seeking a solution to an unprecedented demand for nasal swabs at their own institution and others, USF Health researchers in the Departments of Radiology and Infectious Diseases reached out to colleagues at Northwell Health, New York’s largest health care provider, and leading 3D-printer manufacturer Formlabs. Working around the clock, this multidisciplinary team rapidly designed, tested and produced a 3D printed nasal swab prototype as a replacement for commercially-made flocked nasal swabs. Bench testing (24-hour, 3-day, and leeching) using respiratory syncytial virus as a proxy for SARS-CoV-2, as well as local clinical validation of the final prototype (fabricated with FDA-approved nontoxic, surgical grade materials), was successfully completed in mid-March 2020.

The larger-scale clinical trial began in late March at three sites: Tampa General Hospital (TGH), Northwell Health, and Philadelphia-based Thomas Jefferson University Hospital.  (Other sites joined later.)

The paper’s first author Summer Decker, PhD, directs the USF Health Radiology-TGH Division of 3D Clinical Applications, which creates and prints 3D anatomical models for surgeons and other clinicians and designs medical devices. [Allison Long, USF Health Communications]

“In the midst of a pandemic, our team of experts representing academic medicine, health care delivery systems, and the medical device industry put aside boundaries to quickly work together toward a common purpose,” Dr. Decker said. “It’s rewarding that the novel design for a 3D swab we created has been adopted around the world, equipping more providers to diagnose COVID-19 and hopefully help prevent its spread.”

The gold standard for diagnosing respiratory infections is to look for viral genetic material found in mucosal fluid collected with a long, slender swab inserted into the patient’s nose and back of the throat. The nasal swab is put into a plastic tube with chemicals that stabilize the sample until the virus-specific genetic material can be extracted and amplified by polymerase chain reaction (PCR) in a diagnostics laboratory. Conventional swabs feature a bushy tip coated with nylon flock; the USF Health doctors designed a tip with a 3D printed textured pattern able to capture a sufficient sample for COVID testing while keeping patient safety and comfort in mind.

Kami Kim, MD, infectious diseases division director at USF Health Morsani College of Medicine, led the multisite clinical trial comparing the performance of commercial nasal swabs with the 3D-printed alternative.

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

“This trial provided the first rigorous head-to-head comparison to make sure that the 3D swab performed as well as the standard,” said principal investigator Kami Kim, MD, professor and division director for infectious disease at the USF Health Morsani College of Medicine. “Across all three platforms used in our study, we demonstrated that the commercial swab and the 3D printed swab were comparable for accurate detection of COVID-19 infection.”

For both swabs, the only adverse patient reaction documented during the trial was a few instances of slight nasal bleeding. The cost of materials per 3D printed nasal swab ranges from 26-to 46-cents, while commercial swabs cost about $1 each, the authors reported.

Given the ongoing need for widespread COVID-19 testing, the study authors concluded that 3D printing technology offers a viable, cost-efficient option to address swab supply shortages, particularly when local hospitals or other clinical sites already have 3D printing labs equipped to print and process the devices.

The 3D printed nasal swabs were specifically designed for patients using FDA-approved surgical grade material. [Allison Long, USF Health Communications]

“Among all parts 3D printed during COVID-19, nasopharyngeal swabs have received the most attention, with participants ranging from humanitarians to charlatans,” Dr. Rybicki wrote in his summary. “The authors should be congratulated for staying on the right side of the curve, and for their perseverance, leadership, scientific rigor, and good will.”

The USF Health-designed 3D printed nasal swab that broke into national news in late March is now being used by several hundred hospitals and academic medical centers around the country, many state governments, including that of Ohio, Massachusetts and Virginia, and international agencies and health care facilities.

Widespread use of the nasal swab was one of many goals when it was announced March 28 that USF Health, Formlabs, a leading 3D printing company, Northwell Health, New York’s largest healthcare provider, and Tampa General Hospital had successfully designed, tested and begun producing a 3D printed nasal swab to address emergency shortages that hospitals and health care teams were facing as testing for COVID-19 increased.

The world-wide interest in the swabs kicked in quickly after the announcement and hasn’t let up since, said Dr. Summer Decker, associate professor in the Department of Radiology in the USF Health Morsani College of Medicine and director of 3D Clinical Applications.

“We are grateful that we were able to work as a team to get this solution out so quickly in order to hopefully help many people. The response has been overwhelming,” Decker said. “It’s been very rewarding to speak to so many hospitals across the world to hear their experiences and see how we can help. This situation has stripped away many of the barriers between us so we can work together for the common goal of saving lives.”

Dr. Summer Decker

The nasal swab design came about when, after identifying in mid-March that nasal swabs for testing COVID-19 were in high demand and extremely limited in supply, a team from the USF Health’s 3D Clinical Applications Division created an initial design, working with Northwell Health and collaborating with Formlabs to develop prototypes and secure materials for a 3D printed alternative.

Over the span of one week, the teams worked together to develop a nasal swab prototype and test it in the USF Health and Northwell Health labs. In two days, USF Health and Northwell Health, using Formlabs’ 3D printers and biocompatible, autoclavable resins, developed prototypes.

Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day, and leeching), and rapid clinical testing at Northwell Health and Tampa General Hospital. All testing showed that the 3D printed nasal swabs perform equally to standard swabs used for testing for COVID-19.

Once that clinical validation was complete, 3D printers at USF Health and Northwell Health began producing the swabs and providing them to their patients – USF Health has produced more than 50,000 swabs for its patients and that of some of its affiliates, including Tampa General Hospital, Moffitt Cancer Center, and the James A. Haley Veterans’ Hospital.

“To see the widespread adoption of USF Health’s nasal swab test has been particularly gratifying, and I cannot speak highly enough about Dr. Summer Decker and her team for taking the initiative to meet this pressing need. Health care providers all across the nation are now better equipped to diagnose and prevent the spread of Covid-19,” said Charles J. Lockwood, MD, MHCM, senior vice president for USF Health and dean of the USF Health Morsani College of Medicine.

Photos by Allison Long, USF Health Communications