The Global Burden of Troponin Industry

Cardiovascular diseases (CVD) are the leading cause of death worldwide, accounting for over 17 million deaths each year according to the World Health Organization (WHO). CVD claims more lives each year than all forms of cancer combined. Ischemic heart disease alone is responsible for over 8 million deaths annually and strokes cause over 5 million deaths. The social and economic burden associated with CVD is immense, with costs related to healthcare, lost productivity and decreased quality of life amounting to trillions of dollars globally each year. Early detection and accurate diagnosis of acute coronary syndromes like myocardial infarction are paramount for reducing both mortality and costs associated with heart disease management.

The Pivotal Role of High Sensitivity Cardiac Troponin Testing

Traditional cardiac Global Troponin assays lacked sufficient sensitivity to reliably detect troponins in the early critical hours after the start of a heart attack. The development of high sensitivity cardiac troponin (hs-cTn) assays in the late 2000s dramatically improved detection capabilities, allowing clinicians to identify cardiac injury four to six hours sooner after the start of symptoms compared to previous assays. Multiple large outcome studies have demonstrated hs-cTn improves the early rule-out of acute myocardial infarction which can expedite treatment and lower healthcare costs. International clinical guidelines now recommend measuring hs-cTn as the biomarker of choice for diagnosing myocardial infarction. Nearly all major diagnostic manufacturers now offer hs-cTn assays approved for clinical use.

Global Standardization Efforts are Critical

Worldwide clinical use of hs-cTn testing has significantly increased morbidity and mortality associated with acute coronary syndromes. However, variations between assays from different companies have complicated the ability to compare results across healthcare systems and medical research studies. Lack of assay standardization hindered efforts to set universally agreed upon diagnostic cut-offs for myocardial injury. Significant work by the IFCC Working Group on Clinical Applications of Cardiac Bio-markers and the Standardization Programme Committee has led to the development and introduction of the first certified reference materials and methods for standardizing troponin concentrations internationally. This is allowing more consistent reporting of levels and better worldwide collaboration on clinical guidelines. As the analytical and clinical validation of newer high sensitivity assays continues, reference standards will need ongoing refinement to support informed global clinical decision making.

Advancing Patient Care in Low-Resource Settings

Even with the advantages offered by hs-cTn testing, diagnosing acute cardiac events presents immense challenges in many developing nations and low-resource rural areas. Access to laboratory facilities, infrastructure and healthcare resources is often limited. Point-of-care testing technologies allowing rapid hs-cTn measurement at the patient's bedside hold promise for extending the benefits of early rule-out protocols. A few portable cardiac troponin assays have gained regulatory approvals and initial clinical studies have shown feasibility for use in resource-constrained emergency departments and clinics. Further innovation is still needed to develop assays affordable enough and robust enough to withstand more rugged field conditions. International agencies and public-private partnerships will be important for supporting technology transfer and ensure low-income populations can benefit from scientifically and clinically validated technologies to diagnose heart disease.

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