Is point-of-care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-CoV-2.

Autor:	Micocci M; NIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London St. Mary's Hospital London, London, UK., Gordon AL; Division of Medical Sciences and Graduate Entry Medicine, University of Nottingham, Nottingham, UK.; NIHR Applied Research Collaboration-East Midlands (ARC-EM), Nottingham, UK.; NIHR Nottingham Biomedical Research Centre (BRC), Nottingham, UK., Seo MK; NIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London St. Mary's Hospital London, London, UK., Allen AJ; NIHR Newcastle In Vitro Diagnostics Co-operative, Translational and Clinical Research Institute, Newcastle University, Newcastle Upon Tyne, UK., Davies K; Healthcare Associated Infections Research Group, University of Leeds and Leeds Teaching Hospitals NHS Trust, Leeds, UK.; NIHR Leeds In Vitro Diagnostics Co-operative, Leeds Teaching Hospitals NHS Trust, Leeds, UK., Lasserson D; Warwick Medical School, University of Warwick, Coventry, UK., Thompson C; School of Healthcare, University of Leeds, Leeds, UK.; NIHR Applied Research Collaboration Yorkshire and Humber, Bradford, UK., Spilsbury K; School of Healthcare, University of Leeds, Leeds, UK.; NIHR Applied Research Collaboration Yorkshire and Humber, Bradford, UK., Akrill C; Springfield Healthcare, Leeds, UK., Heath R; Landermeads Nursing Home, Nottingham, UK., Astle A; Wren Hall Nursing Home, Selston, UK., Sharpe C; Ashmere Nottinghamshire Ltd, Notts, UK., Perera R; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK., Hayward G; Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.; NIHR Community Healthcare MedTech and IVD Co-operative, Oxford, UK., Buckle P; NIHR London In Vitro Diagnostics Co-operative, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London St. Mary's Hospital London, London, UK.
Jazyk:	angličtina
Zdroj:	Age and ageing [Age Ageing] 2021 Sep 11; Vol. 50 (5), pp. 1464-1472.
DOI:	10.1093/ageing/afab072
Abstrakt:	Introduction: Reliable rapid testing for COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. This study aimed to examine the usability and test performance of a point of care polymerase chain reaction (PCR) test for detection of SARS-CoV-2 (POCKITTM Central) in care homes. Methods: POCKITTM Central was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and used errors were assessed. Results: No significant usability-related hazards emerged, and the sources of error identified were found to be amendable with minor changes in training or test workflow. POCKITTM Central has acceptable sensitivity and specificity based on RT-PCR as the reference standard, especially for symptomatic cases.Asymptomatic specimens showed 83.3% (95% confidence interval (CI): 35.9-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932- 0.999). Symptomatic specimens showed 100% (95% CI: 2.5-100%) positive agreement and 100% negative agreement (95% CI: 85.8-100%), with overall PABAK of 1.Recommendations are provided to mitigate the frequency of occurrence of the residual use errors observed. Integration pathways were discussed to identify opportunities and limitations of adopting POCKIT™ Central for screening and diagnostic testing purposes. Conclusions: Point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis. (© The Author(s) 2021. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.)
Databáze:	MEDLINE
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