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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.
- Source :
-
Journal of Patient Safety & Risk Management . Dec2021, Vol. 26 Issue 6, p243-250. 8p. - Publication Year :
- 2021
-
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. [ABSTRACT FROM AUTHOR]
- Subjects :
- *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
*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
RESEARCH evaluation
Subjects
Details
- Language :
- English
- ISSN :
- 25160435
- Volume :
- 26
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Journal of Patient Safety & Risk Management
- Publication Type :
- Academic Journal
- Accession number :
- 154068066
- Full Text :
- https://doi.org/10.1177/25160435211054207