期刊
JOURNAL OF PATIENT SAFETY AND RISK MANAGEMENT
卷 26, 期 6, 页码 243-250出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/25160435211054207
关键词
COVID-19; care homes; point-of-care; biohazards
资金
- National Institute for Health Research (NIHR)
- Asthma UK
- British Lung Foundation
- NIHR London In Vitro Diagnostics Co-operative
- NIHR Applied Research Collaboration-East Midlands (ARC-EM)
- NIHR Community Healthcare MedTech and IVD Cooperative
- NIHR Newcastle In Vitro Diagnostics Co-operative
- NIHR Applied Research Collaboration Yorkshire and Humber
- NIHR Applied Research Collaboration (ARC) West Midlands at Oxford Health NHS Foundation Trust
- NIHR Community Healthcare MedTech and IVD Cooperative (MIC) at Oxford Health NHS Foundation Trust
- National Institute for Health Research (NIHR Programme Grant for Applied Research)
- NIHR Oxford Biomedical Research Centre
- NIHR Oxford and Thames Valley Applied Research Collaborative (ARC)
- NIHR Oxford Medtech and In-Vitro Diagnostics Co-operative
- Oxford Martin School
Successful adoption of POCTs for COVID-19 in care homes requires identification of ideal use cases and understanding of contextual and usability factors that affect test results and minimize biosafety risks. The study conducted in UK care homes showed that careful consideration of biosafety issues and contextual factors associated with care homes is mandatory for safe use of POCT, while further diagnostic accuracy evaluations are needed for effective adoption.
Introduction Successful adoption of POCTs (Point-of-Care tests) for COVID-19 in care homes requires the identification of ideal use cases and a full understanding of the contextual and usability factors that affect test results and minimise biosafety risks. This paper presents a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes. Methods A mixed-methods evaluation was conducted in four UK care homes to scope usability and to assess the agreement with qRT-PCR. A dry run with luminescent dye was conducted to explore biosafety issues. Results The agreement analysis was conducted on 227 asymptomatic participants (159 staff and 68 residents) and 14 symptomatic participants (5 staff and 9 residents). Asymptomatic specimens showed 50% (95% CI:1.3%-98.7%) positive agreement and 96% (95% CI: 92.5%-98.1%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.911 (95% CI: 0.857-0.965). Symptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 100% (95% CI: 63.1%-100%) negative agreement with overall prevalence and bias-adjusted Kappa (PABAK) of 0.857 (95% CI: 0.549-1). The dry run highlighted four main sources of contamination that led to the modification of the standard operating procedures. Simulation post-modification showed no further evidence of contamination. Conclusion Careful consideration of biosafety issues and contextual factors associated with care home are mandatory for safe use the POCT. Whilst POCT may have some utility for ruling out COVID-19, further diagnostic accuracy evaluations are needed to promote effective adoption.
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