Implementing cardiovascular precision diagnostics: laboratory specialists as catalysts?

Annals of Clinical Biochemistry International Journal of Laboratory Medicine, vol. 60, pp. 151–154

Abstract

Implementing cardiovascular precision diagnostics: laboratory specialists as catalysts?Christa M Cobbaert Balanced clinical and analytical performance requirements of medical tests?Laboratory specialists in medical labs are accountable for state-of-the-art test menus composed of safe and clinically effective medical tests that are fit-for-clinical-purpose and bring along a favourable benefit/harm ratio for patient management and outcome.A cyclical test evaluation framework, encompassing five interdependent key elements of test evaluation, was developed by the EFLM Working Group on Test Evaluation as a comprehensive tool for test evaluation. 1 In essence, predefined clinical performance specifications mentioned in clinical guidelines should be accompanied by matching analytical performance recommendations of the test.As clinical needs and intended uses of medical tests in clinical care pathways evolve in periodically updated IVD-containing clinical guidelines, it is important that analytical performance characteristics of medical tests keep pace with revised clinical guidelines and new demands.In the case of cardiovascular risk management (CVRM), the routine serum lipid profileconsisting of total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDLc) and high-density lipoprotein cholesterol (HDLc)is without prejudice pivotal in most clinical dyslipidaemia guidelines since the 90s of the past century, based on evidence generated by epidemiological studies, population studies and clinical trials. 2 Clinical practice guidelines for lipid testing started with the USA National Clinical Education Program (NCEP) in 1985. 2 Subsequently, Adult Treatment Panel I, II and III clinical guidelines appeared, followed by AHA/ACC (in 2013 and 2018) and European EAS/ESC and EAS/EFLM guidelines (in 2016 and 2019, respectively) on CVD prevention.[3][4][5] Current clinical guidelines rely on blood LDLc values as primary target to guide treatment

Authors 1

1. Christa M. Cobbaert corresponding Aachen

   Leiden University Medical Center

   Affiliation as printed

   Leiden University Medical Center, Leiden, Netherlands