Evaluating new diagnostic and prognostic biomarkers in cardiovascular disease
- Correspondence to Dr Paul O Collinson, Departments of Cardiology and Clinical Blood Sciences, St George's Hospital and Medical School, London SW17 0RE, UK;
The role of biochemical tests for diagnosis and prognosis of cardiac patients has undergone a remarkable transformation over the course of the past 30 years. The development of assays for the cardiac troponins moved cardiac biomarker measurement in chest pain from Cinderella, ignored in favour of the ECGs, to the princess of diagnostic tests. Troponin now defines myocardial infraction1 and the treatment pathway in non ST elevation myocardial infarction guidelines.2
Novel biomarkers are being constantly developed and offered. The modern diagnostic laboratory can now deliver rapid results for what were previously exotic analytes, such as natriuretic peptides. Cardiac biomarkers have become the new big thing. The availability of a large range of accepted and potential cardiac biomarkers has resulted in the enthusiastic pursuit of biomarker research. Investigators are now in search of novel uses of existing tests or the next new biomarker. It is therefore worth considering what factors should be considered when designing, evaluating, reporting or appraising biomarker studies. Any cardiac biomarker must have three characteristics, the Analytical performance of the assay must be known, there must be Plausibility (biological and clinical) for the marker and finally there must be a Treatment impact either direct or indirect. It must be APT.
The analytical performance of the assay should always be well documented, reported and independently verified (a useful set of criteria has recently been published3). In an era of electronic …