3D-printed nasal swabs work as well as commercial swabs for COVID-19 diagnostic testing, study finds

Date:
September 25, 2020
Source:
University of South Florida (USF Health)
Summary:
A clinical trial provides evidence that 3D-printed alternative
nasal swabs work as well for COVID-19 diagnostic testing as
commercial synthetic flocked nasal swabs. Given the ongoing need
for widespread COVID-19 testing, the researchers conclude that
3D printing technology offers a viable, cost-efficient option to
address swab supply shortages.



FULL STORY ==========================================================================
As COVID-19 quickly spread worldwide this spring, shortages of supplies, including the nasopharyngeal (nasal) swabs used to collect viral samples, limited diagnostic testing.


==========================================================================
Now, a multisite clinical trial led by the University of South Florida
Health (USF Health) Morsani College of Medicine and its primary hospital affiliate Tampa General Hospital (TGH) 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
TGH; 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: TGH, Northwell Health, and Philadelphia-based Thomas Jefferson University
Hospital.

(Other sites joined later.) Although USF Health held a provisional
patent on the concept and design of the new 3D printed swab, they
freely shared the information with hospitals, clinics, governments and international agencies experiencing supply chain shortages. Since the
first batches of 3D printed swabs were processed, tens of millions of
the USF Health-invented devices have been used in 22 countries, said
lead author Summer Decker, PhD, an associate professor of radiology at
the USF Health Morsani College of Medicine. Dr. Decker directs the USF
Health Radiology-TGH Division of 3D Clinical Applications, a group with expertise in creating and printing 3D anatomical models for surgeons
and other clinicians as well as designing medical devices.



==========================================================================
"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.

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.

Frank Rybicki, MD, PhD, vice chair of operations and quality at the
University of Cincinnati College of Medicine's Department of Radiology,
wrote a commentary on 3D printing in medicine to accompany the Clinical Infectious Diseases paper.

The article frames the contributions of Decker et. al. in the context
of the larger 3D manufacturing community.

"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."

========================================================================== Story Source: Materials provided by
University_of_South_Florida_(USF_Health). Original written by Anne
DeLotto Baier. Note: Content may be edited for style and length.


========================================================================== Journal References:
1. Summer J Decker, Todd A Goldstein, Jonathan M Ford, Michael N Teng,
Robert S Pugliese, Gregory J Berry, Matthew Pettengill, Suzane
Silbert, Todd R Hazelton, Jason W Wilson, Kristy Shine, Zi-Xuan
Wang, Morgan Hutchinson, Joseph Castagnaro, Ona E Bloom, Dwayne
A Breining, Barbara M Goldsmith, John T Sinnott, Donna Gentile
O'Donnell, James M Crawford, Charles J Lockwood, Kami Kim. 3D
Printed Alternative to the Standard Synthetic Flocked Nasopharyngeal
Swabs Used for COVID-19 testing.

Clinical Infectious Diseases, 2020; DOI: 10.1093/cid/ciaa1366
2. Frank J Rybicki. 3D Printing in Medicine: COVID-19 Testing with 3D
Printed Nasopharyngeal Swabs. Clinical Infectious Diseases, 2020;
DOI: 10.1093/cid/ciaa1437 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/09/200925113432.htm

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