1. Point of care testing using rapid automated antigen testing for SARS-COV-2 in care homes - an exploratory safety, usability and diagnostic agreement evaluation
- Author
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Ros Heath, Carl Thompson, A Joy Allen, Richard Body, Kerrie Davies, Daniel Lasserson, Cyd Akrill, Patrick Kierkegaard, Gail Hayward, Peter Buckle, Massimo Micocci, Claire Sharpe, Rafael Perera, Adam L. Gordon, Karen Spilsbury, Anita Astle, and Grp, CONDORS
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,Care homes ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,Point-of-care testing ,Biosafety ,HV ,medicine ,care homes ,Antigen testing ,Point of care ,Science & Technology ,biohazards ,business.industry ,COVID-19 ,Usability ,medicine.disease ,Health Care Sciences & Services ,point-of-care ,Emergency medicine ,Dry run ,Health Policy & Services ,Medical emergency ,business ,RA ,Life Sciences & Biomedicine ,RC - Abstract
IntroductionSuccessful 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 contextual and usability factors that affect test results and minimise biosafety risks. This paper presents findings from a scoping-usability and test performance study of a microfluidic immunofluorescence assay for COVID-19 in care homes.MethodsA 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 carried out to explore biosafety issues.ResultsThe agreement analysis was carried out 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 showed four main sources of contamination that led to the modification of the standard operating procedures. Simulation after modification showed no further evidence of contamination.ConclusionCareful 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.
- Published
- 2022
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