The importance of clinical evidence to support point of care tests

It is a truth (almost) universally acknowledged, that point of care testing (POCT) has a place in patient management and that the use of diagnostic testing plays a vital part in guiding disease management, monitoring and improving patient wellbeing (1).  The challenge still faced is the service-wide uptake, adoption and implementation of POCT into our healthcare pathways.

In the post-pandemic era, people have changed the way that they seek medical advice and support. For diagnostic testing, this behaviour change has created opportunities since more people now understand the use and potential benefits of point of care testing in managing and maintaining their health.

Which healthcare setting?

In recent studies the successful implementation of POCT has shown substantial savings, in different settings. The majority of POC testing-related savings have been demonstrated downstream in the process of patient care (2) and clinical benefits for the patients and economic benefits for the healthcare system can result from the use of accurate diagnostics (3).

The repositioning of diagnostic testing solutions out of central laboratories and into either primary or urgent care level, could be a key step for the rapid detection and identification of disease and prevention of transmission to the community as was demonstrated during COVID (4).

In terms of the ideal healthcare setting for POCT, devices can be used to provide results not only in hospitals but remotely in the community in clinics, GP surgeries, pharmacies, and at home through services like “Hospital at home.”

Most vitally, access to point of care in the community allows tests to be performed quickly and close to the patient (5) and accurate, rapid and affordable POC tests can increase access to testing for a wide range of health and disease conditions and facilitate access to healthcare for all (6). In lower resource settings, there is evidence to show that point of care tests has also favourably impacted patient outcomes and be used to drive improvements (7).

Who needs the evidence?

A fundamental piece of the puzzle for the acceptance and implementation of POCT into healthcare pathways is the existence of good clinical data to support the use of the device. Clinical evidence, particularly real-world evidence is important for all stakeholders in the process of diagnostic test development starting with the regulatory approval, procurement teams, trained end users, patient populations, and healthcare professionals. The existence of good evidence can then be used to build confidence, reassurance and understanding that the device performs in the way it is intended, in the population it was designed for.

From a regulatory perspective, in vitro diagnostic devices need to demonstrate the clinical evidence as part of the test development process to include scientific validity, analytical performance, and clinical performance of the product with the Performance evaluation plan to support the intended purpose.

It is also vital to consider and include the development of real-world evidence for diagnostic tests that is based on real world data. The performance data that is presented in the instructions for use is only one part of the data that is needed and required – from a regulatory and an end user perspective. The evidence to show that the product performs in the hands of users, in the setting it is intended for within the cohort of patients is designed for. Real world data can improve our understanding of health and social care delivery, patient health and experiences, and the effects of interventions on patient and system outcomes in routine settings (8). 

About the Author

Lucy Lehane, Founder and MD of Lehane Consulting Ltd.

Lucy is an independent Medical Diagnostics Consultant who began her career in the National Health Service as a Clinical Scientist. It was here that she gained first hand insights into the importance of diagnostic testing in improving health and disease management, and in enhancing patient experiences. Fast forward nearly 25 years, and Lucy has spent her career in the commercial world of diagnostic testing holding leadership roles in Product Management, Technical Marketing and Medical Affairs for several leading diagnostic companies.

In 2023, Lucy established her own consultancy business - Lehane Consulting Ltd. providing medical diagnostics expertise to guide businesses to bring their diagnostic products to market. With over 25 years experience in the medical diagnostics industry, Lehane Consulting can help you develop your clinical evidence plan, establish and manage your scientific advisory committee, write and publish your scientific data and provide expert guidance for your product launch strategy.  

References

1.       Lingervelder D, Koffijberg H, Kusters R, IJzerman MJ. Health Economic Evidence of Point-of-Care Testing: A Systematic Review. Pharmacoecon Open. 2021 Jun;5(2):157-173.

2.      Heerink J.S., et al. Two point-of-care test-based approaches for the exclusion of deep vein thrombosis in general practice: a cost-effectiveness analysis. BMC Primary Care (2023) 24:42. https://doi.org/10.1186/s12875-023-01992-z

3.      Jordan B, Mitchell C, Anderson A, Farkas N, Batrla R. The clinical and health economic value of clinical laboratory diagnostics. Ejifcc. 2015;26(1):47–62.

4.      Vandenberg, O.; Martiny, D.; Rochas, O.; van Belkum, A.; Kozlakidis, Z. Considerations for Diagnostic COVID-19 Tests. Nat.Rev Microbiol. 2021, 19, 171– 183,  DOI: 10.1038/s41579-020-00461-z

5.      Price, C. P., & St John, A. (2019). The value proposition for point-of-care testing in healthcare: HbA1c for monitoring in diabetes management as an exemplar. Scandinavian Journal of Clinical and Laboratory Investigation, 79(5), 298–304.

6.      Howard-Wilson, S., Wang, Z., Orwig, T., Dunlap, D., Hafer, N., Buchholz, B., … Lilly, C. M. (2024). Point-of-care testing preferences 2020–2022: Trends over the years. 

Cardiovascular Digital Health Journal, 5(3), 149–155

https://doi.org/10.1016/j.cvdhj.2024.03.002.

7.      Drain PK, Hyle EP, Noubary F, et al. Diagnostic point-of-care tests in resource limited settings. Lancet Infect Dis 2014;14:239–249.

8.      NICE ECD9 Real-world evidence framework June 2022 Introduction to real-world evidence in NICE decision making | NICE real-world evidence framework | Guidance | NICE