COVID-19 diagnostic testing has expanded exponentially in an international effort to fight the coronavirus pandemic. However, disruption in the medical supply chain caused by this crisis resulted in test kit shortages, including flocked nasopharyngeal FLNP swabs. At the University of South Florida (USF Health), a team of doctors have invented a first 3D device in affiliation with its primary hospital Tampa General Hospital, Northwell Health and Formlabs. A clinical trial give evidence that 3D-printed alternative nasal swabs are as proficient and effective for Covid-19 diagnostic testing as commercial synthetic flocked nasal swabs, hence can be used worldwide to overcome the global shortage of nasal swabs, speeding up the diagnosis process. Study findings concludes that this intervention caters cost effectiveness and viability to address swab supply shortages, results published in Clinical Infectious Diseases.
3D-printed nasal swabs work as well as commercial swabs for COVID-19 diagnostic testing, study finds https://t.co/OchhyVtnSf
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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative virus of Covid-19, usually detected by can be detected by Real-time Reverse Transcriptase (RT)-PCR and molecular methods from the respiratory samples. Yet, limited accessibility of Covid-19 diagnostic testing due to intermittent shortages of supplies emphasize the need to address supply shortfalls. Therefore, team of doctors and researchers at the University of Florida made use of 3D printing intervention to develop an effective stopgap technology for medical devices and supplies.
The multisite clinical trial collected 291 samples from confirmed symptomatic cases of Covid-19 from three different clinical sites. The larger-scale clinical trial began in late March at three sites: TGH, Northwell Health, and Philadelphia-based Thomas Jefferson University Hospital, later on other sites joined. The 3D-printers selected for 3DP swab manufacturing were the Form2 and Form 3B from the Formlabs, USA, used because of its pre-existing validation and FDA-cleared workflows using an autoclavable surgical grade resin, Surgical Guide, FormLabs. The performance of 3D-Printing swabs and flogged nasopharyngeal FLNP swabs were compared by using the samples.
While the USF Health claims a provisional patent on the concept and design of the new 3D printed swab, they freely shared the design and protocol information with hospitals, clinics, governments and international agencies. Since then, a large batch of over tens of millions of 3D-Printed swabs has been manufactured and dispatched to use for diagnosis in up to 22 countries. The analysis to determine effectiveness and viability shows that here were no significant differences between swabs for detection of viral loads. The statistical analysis showed 96% correlation between two swabs.
Therefore, study infers that 3DP swabs are equivalent to standard FLNP in three testing platforms for SARS-CoV-2. Given its worldwide need, 3DP swabs printing manufacturing on-site is an excellent intervention, an alternative to FLNP that can rapidly scale up in response to acute needs when supply chain disruptions affect availability of collection kits.
“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.