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

  1. Massimo Micocci
  2. Peter Buckle
  3. Gail Hayward
  4. A Joy Allen
  5. Kerrie Davies
  6. Patrick Kierkegaard
  7. Karen Spilsbury
  8. Carl Thompson
  9. Anita Astle
  10. Ros Heath
  11. Claire Sharpe
  12. Cyd Akrill
  13. Dan Lasserson
  14. Rafael Perera
  15. Richard Body
  16. Adam L Gordon

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Abstract

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.

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  1. Version published to 10.1177/25160435211054207
  2. ScreenIT

    SciScore for 10.1101/2021.04.22.21255948: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Ethicsnot detected.
    Sex as a biological variablenot detected.
    RandomizationTwo randomly selected care homes (hereafter called care home A and care home B) were asked to conduct the simulation with GloGerm™ liquid, a mineral oil-based solution containing proprietary powder which fluoresces under ultraviolet light, which was used in place of buffer whilst following the SOP.
    Blindingnot detected.
    Power AnalysisNo formal power calculation was undertaken.

    Table 2: Resources

    No key resources detected.

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Study limitations include the small sample size. As such, the findings may not be representative of the 14,000 care homes across the UK. Further, it is recognised that the organisational factors identified in this sample of UK care homes may not be replicated internationally. Furthermore, we have limited knowledge of the physical properties of GloGerm™ (e.g. viscosity) as an appropriate surrogate for a human specimen. Nevertheless, the cautionary nature of our findings, about the need to evaluate new technologies in context in care homes, is likely to have wide application.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    Results from scite Reference Check: We found no unreliable references.

    About SciScore

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  3. Version published to 10.1101/2021.04.22.21255948v2 on medRxiv
  4. Version published to 10.1101/2021.04.22.21255948v1 on medRxiv