Clinical Evaluation of In-House-Produced 3D-Printed Nasopharyngeal Swabs for COVID-19 Testing

Area of Science:

• Biomedical Engineering
• Infectious Disease Diagnostics
• 3D Printing Technology

Background:

• The COVID-19 pandemic created an urgent demand for diagnostic tools, including flocked swabs.
• Anticipated shortages necessitated rapid development of alternative sampling devices.
• A hospital-based 3D-printing platform was established to address this need.

Purpose of the Study:

• To implement and validate 3D-printed swabs for nasopharyngeal and oropharyngeal sampling.
• To assess the diagnostic accuracy of in-house 3D-printed swabs against commercial flocked swabs.
• To establish autonomous hospital-based production of essential diagnostic supplies.

Main Methods:

• Utilized an open-source design for 3D-printed swab production.
• Established a hospital-based 3D-printing platform for manufacturing swabs.
• Conducted a head-to-head diagnostic accuracy study comparing 3D-printed and flocked swabs.

Main Results:

• Achieved excellent concordance between 3D-printed and flocked swabs (96.8% total agreement, Kappa 0.936).
• Demonstrated the reliability of in-house 3D-printed swabs for clinical use.
• Successfully implemented autonomous hospital-based production of diagnostic swabs.

Conclusions:

• 3D-printed swabs are a viable and reliable alternative to commercial flocked swabs, especially during shortages.
• Hospital-based 3D printing can effectively address critical needs for diagnostic tools.
• This study represents the first report on autonomous production and clinical validation of 3D-printed swabs.