Cardiac biomarkers: from harmonisation to hormones over the past decade

The development of highly sensitive immunoassays for certain biomarkers has improved the clinical diagnosis and assessment of many conditions, including heart failure and myocardial infarction. However, differences in their use can cause confusion and uncertainty in the clinical interpretation of the results. Consequently, there was a need for harmonisation, not just in the choice of methods and how they are used, but also in the use of evidence-based diagnostic cut-offs and the advice that is given to clinicians.

There have been are a number of drivers for harmonisation in the delivery of service. For example, the implementation of National Institute for Health and Care Excellence (NICE) guidelines focusing on the harmonisation of clinical care, backed up by harmonisation of the laboratory support. However, different interpretations of the same guidelines can result in variations of service. While laboratories serve a certain geographical area, clinical networks (eg cardiac, renal, cancer etc) can straddle several different laboratories. Clinical networks require a harmonised service, especially if there is patient flow throughout the clinical network and across the geographical boundaries of several laboratories.

The Carter reports outlined the importance of harmonisation, and the pathology Quality, Innovation, Productivity and Prevention (QIPP) programme includes improvement in quality through harmonisation of services. This can occur through a managed route (eg managed consolidated networks) where laboratories would use the same equipment.