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Development of a Quantitative Recombinase Polymerase Amplification Assay with an Internal Positive Control
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Implementing PCR testing in general practice-a qualitative study using normalization process theory.

Sinead Shahrzad1,2, Kirubakaran Balasubramaniam1, Marius Brostrøm Kousgaard2

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Summary

Point-of-care Polymerase Chain Reaction (PCR) testing in general practice showed no clinical need for routine use. The increased workload for general practitioners outweighed the benefits of faster results in non-pandemic settings.

Keywords:
EvaluationImplementationNormalization process theoryPOC PCR testing

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Area of Science:

  • Infectious Disease Epidemiology
  • Diagnostic Technology Assessment
  • General Practice Innovation

Background:

  • The COVID-19 pandemic highlighted the need for rapid, large-scale testing.
  • Community-based Polymerase Chain Reaction (PCR) testing faced logistical and workload challenges.
  • Point-of-care (POC) PCR testing emerged as a potential alternative for viral respiratory infection surveillance.

Purpose of the Study:

  • To assess the enabling and inhibiting factors for implementing POC PCR testing in general practice.
  • To evaluate the routine use of POC PCR for acute respiratory tract infections.
  • To understand general practitioners' perspectives on POC PCR technology.

Main Methods:

  • A 6-week trial of POC PCR testing in 14 general practices in east Zealand, Denmark.
  • Qualitative interviews with general practitioners (GPs) and staff before and after the testing period.
  • Analysis guided by normalization process theory to examine clinical decision-making and collaboration.

Main Results:

  • Professionals perceived no clinical need for POC PCR devices in non-pandemic general practice.
  • While results were faster for patients, GPs experienced increased tasks and workload.
  • The time savings did not benefit the general practitioner directly.

Conclusions:

  • Current POC PCR testing technology does not offer sufficient added diagnostic value to justify the increased workload in daily general practice.
  • Implementation challenges related to workflow and perceived clinical utility need to be addressed.
  • Further research is needed to optimize POC PCR for routine general practice settings.