Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes - an exploratory safety, usability and diagnostic agreement evaluation

Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes - an exploratory safety, usability and diagnostic agreement evaluation

<strong> Introduction<br></strong> 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. Th...

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Bibliographic Details
Main Authors: Micocci, M, Buckle, P, Hayward, G, Allen, AJ, Davies, K, Kierkegaard, P, Spilsbury, K, Thompson, C, Astle, A, Heath, R, Sharpe, C, Akrill, C, Lasserson, D, Perera, R, Body, R, Gordon, AL
Other Authors: Grp, CONDORS
Format: Journal article
Language:English
Published: SAGE Publications 2021
Description
Summary:<strong> Introduction<br></strong> 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. <br><strong> Methods<br></strong> 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. <br><strong> Results<br></strong> 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. <br><strong> Conclusion<br></strong> 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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