Prospective Clinical Validation of 3D Printed Nasopharyngeal Swabs for Diagnosis of COVID-19

Oland, Gabriel; Garner, Omai; Maurice, Annabelle de St

COVID-19 greatly disrupted the global supply chain of nasopharyngeal swabs, and thus new products have come to market with little data to support their use. In this prospective study, two new 3D printed nasopharyngeal swab designs were evaluated against the standard, flocked nasopharyngeal swab for the diagnosis of COVID-19. 70 adult patients (37 COVID-positive and 33 COVID-negative) underwent consecutive diagnostic RT-PCR testing, with a flocked swab followed by one or two 3D printed swabs. The “Lattice Swab” (manufacturer Resolution Medical) demonstrated 93.3% sensitivity (95% CI, 77.9-99.2%) and 96.8% specificity (83.3-99.9%), yielding κ = 0.90 (0.85-0.96). The “Origin KXG” (manufacturer Origin Laboratories) demonstrated 83.9% sensitivity (66.3-94.6%) and 100% specificity (88.8-100.0%), yielding κ = 0.84 (0.77-0.91). Both 3D printed nasopharyngeal swab results have high concordance with the control swab results. The decision to use 3D printed nasopharyngeal swabs during the COVID-19 pandemic should be strongly considered by clinical and research laboratories.