Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes – an exploratory safety, usability and diagnostic agreement evaluation.
Autor: | Micocci, Massimo, Buckle, Peter, Hayward, Gail, Allen, A Joy, Davies, Kerrie, Kierkegaard, Patrick, Spilsbury, Karen, Thompson, Carl, Astle, Anita, Heath, Ros, Sharpe, Claire, Akrill, Cyd, Lasserson, Dan, Perera, Rafael, Body, Richard, Gordon, Adam L |
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Předmět: |
VIRAL antigens
SAFETY USER-centered system design RESEARCH STATISTICS REVERSE transcriptase polymerase chain reaction HAZARDOUS substance safety measures COVID-19 PREDICTIVE tests CONFIDENCE intervals INDUSTRIAL safety RESEARCH evaluation POINT-of-care testing RESEARCH methodology INTERVIEWING NURSING care facilities SURVEYS DESCRIPTIVE statistics FLUORESCENT antibody technique RESEARCH funding COVID-19 testing STATISTICAL sampling THEMATIC analysis POLYMERASE chain reaction COLLECTION & preservation of biological specimens VIDEO recording |
Zdroj: | Journal of Patient Safety & Risk Management; Dec2021, Vol. 26 Issue 6, p243-250, 8p |
Abstrakt: | 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. [ABSTRACT FROM AUTHOR] |
Databáze: | Complementary Index |
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