Efficacy and Safety of a Medical Robot for Non-Face-to-Face Nasopharyngeal Swab Specimen Collection: Nonclinical and Clinical Trial Findings for COVID-19 Testing.

Abstract

ObjectivesTo meet the high demand for polymerase chain reaction (PCR) tests to diagnose COVID-19 and rapidly control the outbreak, an efficient and safe molecular diagnostic protocol is necessary. In this study, we evaluated the efficacy and safety of the medical robot developed for non-face-to-face nasopharyngeal swab specimen collection.MethodsIn a nonclinical study, an otorhinolaryngologist collected swab specimens manually and using a medical robot. In a single-institution, randomized, open-label, prospective, exploratory clinical trial, nasopharyngeal swab specimens were collected from the enrolled participants both manually and by using the medical robot.ResultsEvaluation of the efficacy and safety of nasopharyngeal swab collection using a medical robot was assessed. After the operation of the robot, subjective discomfort experienced by the participants and any side effects or abnormalities in the nose were also monitored. Preliminary nonclinical data revealed comparable results between robotic and manual methods in terms of RNA metrics and cytokeratin-8 expression. Minor initial damage to A549 cells by the robot improved with subsequent use. In the clinical setting, the robot-assisted technique yielded a 92.31% detection rate for human RNase P, while the manual method achieved 100%. Post-swabbing discomfort reported by participants was similar for both methods and resolved within 48 h.ConclusionsThe medical robot system could efficiently, safely, and accurately collect nasopharyngeal swab samples in a non-face-to-face manner. Its installation in respiratory clinics, airports, or ports could minimize the infection risk between individuals and healthcare workers, thereby contributing to an efficient distribution of medical resources.