Is Point-of-Care testing feasible and safe in care homes in England? An exploratory usability and accuracy evaluation of a point-of-care polymerase chain reaction test for SARS-COV-2

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

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Abstract

Introduction

Reliable rapid testing on COVID-19 is needed in care homes to reduce the risk of outbreaks and enable timely care. Point-of-care testing (POCT) in care homes could provide rapid actionable results. This study aimed to examine the usability and test performance of point of care polymerase chain reaction (PCR) for COVID-19 in care homes.

Methods

Point-of-care PCR for detection of SARS-COV2 was evaluated in a purposeful sample of four UK care homes. Test agreement with laboratory real-time PCR and usability and use errors were assessed.

Results

Point of care and laboratory polymerase chain reaction (PCR) tests were performed on 278 participants. The point of care and laboratory tests returned uncertain results or errors for 17 and 5 specimens respectively. Agreement analysis was conducted on 256 specimens. 175 were from staff: 162 asymptomatic; 13 symptomatic. 69 were from residents: 59 asymptomatic; 10 symptomatic. Asymptomatic specimens showed 83.3% (95% CI: 35.9%-99.6%) positive agreement and 98.7% negative agreement (95% CI: 96.2%-99.7%), with overall prevalence and bias-adjusted kappa (PABAK) of 0.965 (95% CI: 0.932 – 0.999). Symptomatic specimens showed 100% (95% CI: 2.5%-100%) positive agreement and 100% negative agreement (95% CI: 85.8%-100%), with overall PABAK of 1. No usability-related hazards emerged from this exploratory study.

Conclusion

Applications of point-of-care PCR testing in care homes can be considered with appropriate preparatory steps and safeguards. Agreement between POCT and laboratory PCR was good. Further diagnostic accuracy evaluations and in-service evaluation studies should be conducted, if the test is to be implemented more widely, to build greater certainty on this initial exploratory analysis.

Key points

  • Point of care tests (POCT) in care homes are feasible and could increase testing capacity for the control of COVID-19 infection.

  • The test of agreement between POCT and laboratory PCR for care home residents and the staff was good.

  • Adoption of POCT in care homes can be considered with appropriate preparatory steps and safeguards in place.

  • Repetitive errors and test malfunctioning can be mitigated with bespoke training for care home staff.

  • Integrated care pathways should be investigated to test the high variability of the context of use.

Article activity feed

  1. Version published to 10.1101/2020.11.30.20240010v2 on medRxiv
  2. Version published to 10.1093/ageing/afab072
  3. ScreenIT

    SciScore for 10.1101/2020.11.30.20240010: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    BlindingSamples were not blinded at any stage.
    Power AnalysisOnly staff members who received formal training were permitted to use the machine This study consists of two activities: No formal power calculation was undertaken.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Further evaluation of diagnostic accuracy is being conducted in other parts of the CONDOR platform.
    CONDOR
    suggested: (Condor, RRID:SCR_017664)

    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:
    A limitation of this study, which it is important to recognise, is that it was not statistically powered as a diagnostic accuracy study. The low number of positives seen explains the wide confidence intervals reported for all estimates, particularly positive agreement. We report several measures of agreement stratified by symptomatic/asymptomatic to reflect potential different use of these tests. These statistics have been shown to have limitations and biases but can serve as an indication of overall agreement between these tests, hence our reporting of multiple measures alongside full test results. Our sensitivity analysis to explore the impact of POCKIT™ Central uncertain results and machine errors showed our results to be robust. Another limitation is the relatively small sample of care homes involved. Although we sought to evaluate the technology in a purposive sample of homes that represented the range of training and registration across UK care homes more generally, the organisational configuration of UK care is recognised to be highly heterogeneous. Also, the “early adopter” care homes that routinely engage with research or service development by academics might be atypical. If wider roll-out of POCKIT™ Central in care homes were to be considered as a consequence of this evaluation, we would recommend doing so in a staged way, with further in-service evaluation studies to tailor training/training material for care homes staff and to fully assess how POCKIT™ Central can...

    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.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  4. Version published to 10.1101/2020.11.30.20240010v1 on medRxiv