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Evaluation of Point of Care Tests in primary care - Jan Verbakel

What makes the perfect Point of Care Test? Evaluating Point of Care Testing (POCT) in primary care

Over the past few decades, diagnostic technologies have evolved and a growing number of Point of Care Tests are now available in the primary care setting. But which tests do GPs want most? And how do we evaluate which devices are worth implementing?
 

In this webinar, Dr. Jan Verbakel outlines the framework the EPI Centre uses to evaluate new technologies and shows how POCT within a primary care setting could reduce unnecessary antibiotic prescribing in children. The views shared in the webinar have been summarised below.

 

The evolution of Point of Care Testing (POCT) in primary care

 

Clinical practice has evolved from the traditional view of a GP relying on ‘low-tech’ clinical reasoning into a practice that involves Point of Care Tests, such as troponin, HbA1c, CRP, D-dimers, urine dipsticks – and recently, Covid-19 testing.

As Dr. Jan Verbakel highlights from a study performed amongst GPs in Australia, Belgium, The Netherlands, UK and USA1, most GP's are using urine pregnancy tests, urine dipstick tests and blood glucose testing. However, they would like to be able to test for UTIs, pulmonary embolism, acute cardiac markers and infectious disease.

 

Evaluating POCT in primary care

 

In his role at Oxford University, Dr. Jan Verbakel performs ‘horizon scanning’ to identify new and emerging diagnostic technologies that are relevant to primary care in the NHS. Utilising the Horvath Framework, his research shows that while some disease areas are covered for analytical and clinical performance, there’s very little evidence on the clinical effectiveness and cost-effectiveness of new technologies – and the median time for completing the evaluation cycle is comparable to developing a new drug2

 

In addition, POCT faces the following challenges in primary care:

  • Complexity of data management and oversight
  • Is faster always better?
  • Verification and monitoring of analytical performance
  • Complicated by multiple instruments and cartridges

The EPI Centre aims to evaluate primary care innovations for analytical performance, clinical performance, clinical effectiveness, cost-effectiveness and the broader impact within the primary care setting.

 

Evaluating POCT: CRP and antimicrobial resistance

 

Children are at high-risk for unnecessary antibiotic prescribing due to diagnostic uncertainty. In fact, in Belgium, almost every child receives one antibiotic prescription per year. Could POCT be used to support better targeting of antibiotic prescribing?

  • C-reactive protein (CRP) is an acute-phase protein produced by the liver in response to local inflammation. 
  • A systematic review showed that CRP could be a promising biomarker for detecting serious infection in children. Two devices available at the time were found to be analytically and clinically accurate.
  • A review from the Cochrane Library3 looked at the value of CRP POCT to guide antibiotic prescribing and found a reduction of more than 20% when using POCT in primary care. This led to the introduction of CRP POCT within the NICE guidelines.
  • Clinical performance of CRP POCT in children: Some discrepancies between test and lab, but not considered clinically relevant.
  • Impact on patient-relevant outcomes: A trial showed applying CRP POCT enabled physicians to better determine which children needed further testing.
  • Several studies have confirmed that CRP POCT may better target antibiotic prescribing for children with acute RTIs, but more research is urgently needed. 
  • Dr. Jan Verbakel has initiated the ARON trial, which applies a clinical algorithm, including CRP POCT and safety netting advice, to avoid unnecessary prescribing in children – the trial is currently recruiting, and the results will be presented soon.

 

Evaluating POCT: Paediatric urinary tract infection

 

Not all POCT tests deliver patient-relevant outcomes. 

  • ERNIE4 was a prospective cross-sectional diagnostic accuracy study held at 39 general practices and two emergency departments. It involved the systematic urine sampling of acutely ill children. 
  • The aim was to use a high sensitivity test and rule out a urine culture if the test was negative. 
  • The study considered three different POC tests, but unfortunately, while the specificity was quite high, the sensitivity in all tests was not high enough to rule out a UTI.

 

What makes the perfect POCT Test?

 

Dr. Jan Verbakel concludes his presentation by outlining the features of the ideal POCT test. His must-haves are:

  • Accurate and reliable
  • Impacts patient-relevant outcomes
  • Supports clinical decision-making
  • Cost-effective
  • Easy to use


He also outlines some features that are ‘nice to have’: 

  • Portability (fits in the doctor’s bag)
  • Allows for multiple readings, fast results (2mins, max 5 mins)
  • Non-invasive
  • Allows linkage with the patient’s electronic health record

References:

  1. Howick J et al. (2014). Current and future use of point-of-care tests in primary care: an international survey in Australia, Belgium, The Netherlands, the UK and the USA. BMJ Open 4:e005611. doi:10.1136/bmjopen-2014-005611 
  2. Verbakel JY et al. (2017). Common evidence gaps in point-of-care diagnostic test evaluation: a review of horizon scan reports. BMJ Open 7:e015760. doi:10.1136/bmjopen-2016-015760
  3. Cochrane Database of Systematic Reviews. (2014). doi:10.1002/14651858.CD010130.pub2

 

The views and opinions expressed in this webinar are those of the speakers and do not necessarily reflect the views or positions of Roche or any other sponsors.

Biography

Dr. Jan Verbakel is a Professor and Research Coordinator at the KU Leuven, a University in Belgium. He is also an Honorary Senior Clinical Researcher at the Nuffield Department of Primary Care Sciences at the University of Oxford and an advisor on the expert panel to the European Commission in the field of medical devices and in-vitro diagnostics. In addition, he is the co-founder of the newly established EPI-Centre, KU Leuven www.epi-centre.be and a certified general practitioner at a GP practice in Belgium.

Key points
  • The role of a GP has evolved to include many Point of Care Tests.
  • When evaluating POCT technology, consider analytical performance, clinical performance, clinical effectiveness, cost effectiveness and the broader impact within the primary care setting.
  • Several studies have confirmed that CRP POCT may better target antibiotic prescribing for children with acute RTIs, but more research is urgently needed. 
  • The ideal Point of Care Test is accurate and reliable, impacts patients’ relevant outcomes, supports clinical decision-making, is cost effective and easy to use.
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ASPIRE Point of Care Webinars

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