The invention that was shared with the world: Experts came together quickly in early 2020 to create a 3D-printed nasopharyngeal swab. Today, more than 100 million swabs have been produced across the globe using this USF-patented design, and the U.S. Patent and Trademark Office is honoring the USF Health team Feb. 16, 2023.

The University of South Florida (USF) has been awarded the Patents for Humanity award by the U.S. Patent and Trademark Office (USPTO) for its patent of the 3D-printed nasopharyngeal (NP) swab, created in the early part of the pandemic as a solution to the disrupted commercial production of standard flocked NP swabs critical in diagnostic testing for COVID-19.

USF is among an exclusive group of winners receiving this year’s Patents for Humanity awards, being named alongside the National Institute of Allergy and Infectious Diseases of the NIH, Regeneron Pharmaceuticals, Gilead Sciences Inc., and Caron Products. All will be honored by the USPTO at an awards ceremony on February 16, 2023.

USF is earning this recognition for its innovative solution to the commercial NP swab shortage. Due to the urgent need worldwide, the 3D-printed NP swab team decided to forgo monetization of their invention and provided the design files and clinical data at no cost to hospitals, clinics and licensed medical device companies around the world as long as the swabs were produced for their own use.

Over the span of one week in March 2020, teams from USF Health, Northwell Health, Tampa General Hospital, and Formlabs worked together to develop a 3D printed swab prototype using Formlabs’ 3D printers and biocompatible (not harmful), autoclavable materials (able to withstand elevated temperature and pressure of an autoclave). The prototypes were then benchmarked against standard flocked swabs for viral sample retention in the laboratory and tested for patient safety and comfort by USF Health Morsani College of Medicine Department of Internal Medicine researchers. After passing these tests, the teams initiated a multisite clinical trial at dozens of hospital sites across the United States, including Tampa General Hospital, Northwell Health in New Hyde Park, New York, and Thomas Jefferson University Hospital in Philadelphia, comparing performance of the 3D-printed nasopharyngeal swabs with flocked swabs.

From that point on, the USF/Northwell design was shared with hospitals, health systems, the military, and clinics around the globe. To date, the USF-patented design for the 3D-printed nasopharyngeal swab has been shared with institutions in more than 60 countries that have produced more than 100 million swabs.

“I am so proud of how our USF Health team stepped forward to combine their expertise and innovation with the teams from Tampa General Hospital, Formlabs and Northwell Health to help save lives around the world,” said Charles J. Lockwood, MD, MHCM, executive vice president for USF Health and dean of the USF Health Morsani College of Medicine, and executive vice president and chief academic officer at Tampa General Hospital. “This recognition by the U.S. Patent and Trademark Office validates both the tremendous power of academic medicine, especially during a crisis, and the values and commitment these teams have for contributing to the greater good.”

“Our goal from the start was to help as many people as possible, as fast and safely as possible,” said Summer Decker, PhD, professor in the USF Health Morsani College of Medicine, and director for 3D Clinical Applications in USF Health’s Department of Radiology, who led the 3D printed NP swab team. “In order to do that, we assembled a team of experts in our fields and worked together toward a real-world solution. We then made our files public so that any hospital, clinic or health system could print them for their own facilities and get them to the frontline of COVID-19 testing in patients. Only when you know what you are truly facing, in this case COVID-19, can you actually fight it. This swab was a critical, missing component of the global medical community’s ability to do just that. We are very humbled by this recognition by the U.S. Patent and Trademark Office for our efforts and very grateful for this incredible opportunity to help not just USF Health and Tampa General Hospital, but also other hospitals and medical centers throughout the world.”

“COVID-19 demanded innovation and collaboration, not only from those on the front lines but across industries,” said Todd Goldstein, PhD, director of 3D Design and Innovation at Northwell Health. “It’s an honor to receive this recognition from the U.S. Patent and Trademark Office and we hope that our 3D printed nasal swab design helped alleviate burden during the height of the pandemic and showed what cooperation, even in times of crisis, can achieve.”

“We were proud to unite with USF Health, Formlabs and Northwell Health to work quickly and collaboratively to save lives during the height of COVID-19 when swabs were in short supply and in such high demand,” said John Couris, president and CEO of Tampa General Hospital. “This recognition is a true testament to not only the power of academic medicine, but the hard work, sacrifice, innovative spirit and perseverance of our clinical teams and their ability to act quickly and think strategically. We are thankful for the partnerships we developed with other health leaders to find innovative and cost-effective solutions to protect the health of our region and beyond.”

“With quick thinking and action from USF Health, the global shortage of traditional nasopharyngeal swabs was minimized with an entirely 3D printable design that could be easily printed in health care facilities around the world,” said Gaurav Manchanda, director of Medical Market Development at Formlabs. “We were honored to help in this effort and pleased to see the reliability, scalability, and accessibility of our 3D printing solutions put into action. By combining the centralized quality, regulatory, and medical manufacturing expertise at Formlabs with a decentralized production network of global medical customers, local health institutions were able to print and use millions of swabs needed during the shortage. Formlabs is proud to be recognized alongside USF Health, Northwell Health, and Tampa General Hospital in the USPTO Patents for Humanity COVID-19 category.”

The team that created the USF-patented 3D printed nasal swab, from left, Jonathan Ford, Kami Kim, John Sinnott, Summer Decker, Todd Goldstein, and Michael Teng. Not pictured is Todd Hazelton.

— Video and photos by Allison Long, USF Health Communications

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