In August 2020, at the height of the COVID-19 pandemic, the U.S. Food and Drug Administration reported shortages in the national supply of nasal swabs used to test for the virus, among other supplies such as personal protective equipment.
While VA went on to secure an adequate supply of swabs, the FDA cited a larger national shortage as recently as March of this year.
Although the pandemic has receded and many Americans have been vaccinated, VA isn’t taking any chances. VA researchers are studying the safety and effectiveness of 3D-printed nasal swabs, in case of another urgent nationwide need to test patients for COVID-19 or other infectious diseases. The agency is hoping to offset further potential shortages of traditional swabs in the commercial supply chain and aims to provide scientific evidence of the value of 3D swabs to the non-VA health care system, as part of VA’s mission to support national health care during the pandemic.
Dr. Joseph Iaquinto, a biomedical engineer at VA Puget Sound, is leading the study.
Researchers may also be able to detect common viruses
Dr. Joseph Iaquinto, a biomedical engineer in the VA Center for Limb Loss and Mobility at VA Puget Sound in Washington state, is leading the study. His team is aiming to examine the viability of five types of 3D swabs, two of which have been produced by VA and the rest by commercial 3D printing companies. Iaquinto believes 3D swabs were not on the commercial market before the pandemic.
Part of the “elegance” of the study, Iaquinto says, is that the researchers are using a swab cartridge that can simultaneously test for a battery of viruses. There are six viral targets, including the novel coronavirus, Flu A, Flu B, and the respiratory syncytial virus (RSV), the most important cause of lower respiratory tract infection in young children.
“Our focus for the study is COVID-19,” Iaquinto says. “But if these 3D-printed swabs show the ability to collect and release viral matter for clinical testing, then they may be suitable for many use cases, including the detection of common viruses.”
`Quickly print it into the real world’
Since the start of the pandemic, VA innovators, researchers and clinicians have helped build a more resilient supply chain of personal protective equipment and other supplies to support VA’s response to the health crisis. These items have included face masks, face shields, hoods, desk shields and nasal testing swabs. In many cases, 3D printing has been involved due to its flexibility in producing new products.
The benefit of 3D printing is the ability to “radically change your digital design or to design something entirely different, then quickly print it into the real world,” Iaquinto explains. “That allows you to prototype or flex production with higher speed than other pathways.”
In the nasal swab study, researchers intend to provide statistical evidence on the safety and effectiveness of 3D swabs in use and nearing readiness for use. The goal is to identify which 3D swab designs, if any, provide the same clinical result as traditional swabs.
`Collaboration at its best’
The study calls for swabbing Veterans and VA employees for COVID-19 testing who show up as a matter of routine care. But the researchers are amending the study to recruit patients who are in the hospital, have contracted COVID-19, or are symptomatic but are not scheduled for swabbing.
The VA Innovation Ecosystem and the VA Office of Research and Development are collaborating to support the study. VA Ventures, which was formed last year in partnership with the Innovation Ecosystem, is one of the VA programs that has designed, fabricated and evaluated equipment for VA’s COVID-19 response. Iaquinto is also affiliated with VA Ventures, which is managing the swab production facility at VA Puget Sound.
“This study is a great example of how multiple services at VA – the Innovation Ecocystem, the Office of Research and Development, the National Program Office for Sterile Processing, Procurement and Logistics, and the Pathology and Laboratory Medicine Service – are working together to support VA’s continuity of care for its Veterans and employees,” Iaquinto says. “It’s collaboration at its best.”
Click here to read the full story.
Click here to learn more about VA research.