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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.
- COVID-19
- Diagnosis
- Investigative Techniques
- Virus Diseases
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Footnotes
Contributors SKM and ST conceived the study idea. SKM and ST did the statistical analysis and directly accessed and verified the underlying data reported in the manuscript. SKM, ST and SV contributed to project administration. SKM and ST contributed to data collection and provision of patients. All authors contributed to data interpretation. SKM and ST wrote the first draft of the manuscript, and all authors reviewed and approved the final version. SKM and ST were responsible for the decision to submit the manuscript. All authors reviewed the manuscript. All authors had access to all the data in the study.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.
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