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Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation
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Micocci, Massimo, Buckle, Peter, Hayward, Gail, Allen, Jo, Davies, Kerrie, Kierkegaard, Patrick, Spilsbury, Karen, Thompson, Carl, Astle, Anita, Heath, Ros, Sharpe, Claire, Akrill, Cyd, Lasserson, Daniel, Perera, Rafael, Body, Richard and Gordon, Adam L. (2021) Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation. Journal of Patient Safety and Risk Management, 26 (6). pp. 243-250. doi:10.1177/25160435211054207 ISSN 2516-0435.
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Official URL: https://doi.org/10.1177/25160435211054207
Abstract
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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | H Social Sciences > HV Social pathology. Social and public welfare R Medicine > RA Public aspects of medicine R Medicine > RC Internal medicine |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||||||
| Library of Congress Subject Headings (LCSH): | COVID-19 (Disease) , COVID-19 (Disease) -- Prevention, COVID-19 (Disease) -- Transmission -- Prevention, Point-of-care testing , COVID-19 (Disease) -- Diagnosis , Nursing home care -- Health aspects -- Safety measures, Older people -- Nursing home care, Old age homes -- Health aspects -- Safety measures | ||||||||||||
| Journal or Publication Title: | Journal of Patient Safety and Risk Management | ||||||||||||
| Publisher: | Sage Publications Ltd | ||||||||||||
| ISSN: | 2516-0435 | ||||||||||||
| Official Date: | 1 December 2021 | ||||||||||||
| Dates: |
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| Volume: | 26 | ||||||||||||
| Number: | 6 | ||||||||||||
| Page Range: | pp. 243-250 | ||||||||||||
| DOI: | 10.1177/25160435211054207 | ||||||||||||
| Status: | Peer Reviewed | ||||||||||||
| Publication Status: | Published | ||||||||||||
| Reuse Statement (publisher, data, author rights): | Posted ahead of print. Micocci, Massimo, Buckle, Peter, Hayward, Gail, Allen, Jo, Davies, Kerrie, Kierkegaard, Patrick, Spilsbury, Karen, Thompson, Carl, Astle, Anita, Heath, Ros, Sharpe, Claire, Akrill, Cyd, Lasserson, Daniel, Perera, Rafael, Body, Richard and Gordon, Adam L. (2021) Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation. Journal of Patient Safety and Risk Management . (In Press) Copyright © [year] (Copyright Holder). Reprinted by permission of SAGE Publications. DOI: [DOI] Users who receive access to an article through a repository are reminded that the article is protected by copyright and reuse is restricted to non-commercial and no derivative uses. | ||||||||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||||||||
| Date of first compliant deposit: | 24 September 2021 | ||||||||||||
| Date of first compliant Open Access: | 27 September 2021 | ||||||||||||
| RIOXX Funder/Project Grant: |
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