S K Mohanasundari, Sivam Thanigainathan, R Gadapalli, Pankaj Rawat, S Vandana, K Deepak, N Gupta
{"title":"一项探索性研究,旨在评估新型自取式鼻咽清洗标本收集装置的功能能力、安全性和分离新型 COVID-19 的能力","authors":"S K Mohanasundari, Sivam Thanigainathan, R Gadapalli, Pankaj Rawat, S Vandana, K Deepak, N Gupta","doi":"10.1136/bmjinnov-2023-001122","DOIUrl":null,"url":null,"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.","PeriodicalId":53454,"journal":{"name":"BMJ Innovations","volume":null,"pages":null},"PeriodicalIF":1.4000,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"S K Mohanasundari, Sivam Thanigainathan, R Gadapalli, Pankaj Rawat, S Vandana, K Deepak, N Gupta\",\"doi\":\"10.1136/bmjinnov-2023-001122\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":53454,\"journal\":{\"name\":\"BMJ Innovations\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.4000,\"publicationDate\":\"2024-01-10\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMJ Innovations\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1136/bmjinnov-2023-001122\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"HEALTH CARE SCIENCES & SERVICES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMJ Innovations","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1136/bmjinnov-2023-001122","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}
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
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.
期刊介绍:
Healthcare is undergoing a revolution and novel medical technologies are being developed to treat patients in better and faster ways. Mobile revolution has put a handheld computer in pockets of billions and we are ushering in an era of mHealth. In developed and developing world alike healthcare costs are a concern and frugal innovations are being promoted for bringing down the costs of healthcare. BMJ Innovations aims to promote innovative research which creates new, cost-effective medical devices, technologies, processes and systems that improve patient care, with particular focus on the needs of patients, physicians, and the health care industry as a whole and act as a platform to catalyse and seed more innovations. Submissions to BMJ Innovations will be considered from all clinical areas of medicine along with business and process innovations that make healthcare accessible and affordable. Submissions from groups of investigators engaged in international collaborations are especially encouraged. The broad areas of innovations that this journal aims to chronicle include but are not limited to: Medical devices, mHealth and wearable health technologies, Assistive technologies, Diagnostics, Health IT, systems and process innovation.