Exploratory study to assess the functional capacity, safety and ability to isolate novel COVID-19 of a novel self-administrative nasopharyngeal wash specimen collecting device

Abstract

Introduction Although nasopharyngeal/oropharyngeal swabs are considered the gold standard for SARS-CoV-2 diagnosis, these procedures are distressing, require trained personnel and may pose a risk of transmission. Aim This study aims to assess the functional capacity, safety, ability to isolate the novel COVID-19 and end-users’ acceptance of a novel self-collection device for obtaining nasopharyngeal wash samples. Methods Initially, the novel device’s functional capacity (amount of nasopharyngeal wash specimen collected by participants themselves using the novel device) and safety (procedure-related complications such as bleeding, aspiration or syncope) were assessed in 15 healthy volunteers. Then, its ability to isolate the novel COVID-19 in symptomatic patients, procedure-related discomfort and end-users’ acceptance were compared with the conventional nasopharyngeal/oropharyngeal swab technique. Results All 15 volunteers obtained more than 1 mL of nasopharyngeal wash sample using the novel device, with no reported medical complications. Out of 14 COVID-19-suspected patients, 9 tested positive using the novel method compared with 8 with the conventional method (p=0.09). The novel method demonstrated significantly less discomfort (median score 1 vs 5, p<0.001) and significantly higher acceptability (median score 9 vs 2, p<0.001) compared with the conventional method. Conclusion The novel self-administrative nasopharyngeal wash specimen-collecting device allowed patients to collect samples safely. The procedure could isolate the novel COVID-19 from the nasopharynx, similar to the conventional nasopharyngeal swab technique. The novel method was less discomforting and more acceptable for end-users compared with the conventional method and is suitable for mass screening.