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Lower Limits for Reporting High-Sensitivity Cardiac Troponin Assays and Impact of Analytical Performance on Patient
Kristin M Aakre1,2, Fred S Apple3,4, Nicolas L Mills5,6
1Department of Medical Biochemistry and Pharmacology and Department of Heart Disease, Haukeland University Hospital, Bergen, Norway.
Insights
Accurate cardiac troponin measurements are crucial for diagnosing heart attacks and predicting cardiovascular disease risk. Improving analytical quality at low concentrations is vital for patient care and accelerated diagnostic pathways.
Area of Science:
- Clinical Chemistry
- Biomarker Analysis
- Cardiovascular Diagnostics
Background:
- Cardiac troponin measurements are essential for diagnosing myocardial infarction and predicting cardiovascular disease risk.
- Accelerated diagnostic pathways utilize low cardiac troponin concentrations, sometimes below the limit of quantification, raising concerns about analytical imprecision and patient misclassification.
Approach:
- This mini-review by the IFCC C-CB examines the impact of reporting low cardiac troponin concentrations on assay classification and utility in accelerated diagnostic pathways.
- It provides practical suggestions for laboratories on analytical quality assessment of cardiac troponin results at low cutoffs, focusing on accelerated diagnostic pathways.
Key Points:
- Reporting low cardiac troponin concentrations affects assay classification as high-sensitivity.
- Analytical performance at low concentrations is critical for the effectiveness of accelerated diagnostic pathways.
- Future applications of cardiac troponins for risk prediction and management may necessitate enhanced analytical quality.
Conclusions:
- Clinical guidelines advocate for using cardiac troponin concentrations near the limit of detection for patient care.
- Laboratories, manufacturers, researchers, and EQA providers must extend analytical performance monitoring to include low concentration ranges relevant to accelerated diagnostic pathways.
Background:
Cardiac troponin measurements are indispensable for the diagnosis of myocardial infarction and provide useful information for long-term risk prediction of cardiovascular disease. Accelerated diagnostic pathways prevent unnecessary hospital admission, but require reporting cardiac troponin concentrations at low concentrations that are sometimes below the limit of quantification. Whether analytical imprecision at these concentrations contributes to misclassification of patients is debated.
Content:
The International Federation of Clinical Chemistry Committee on Clinical Application of Cardiac Bio-Markers (IFCC C-CB) provides evidence-based educational statements on analytical and clinical aspects of cardiac biomarkers. This mini-review discusses how the reporting of low concentrations of cardiac troponins impacts on whether or not assays are classified as high-sensitivity and how analytical performance at low concentrations influences the utility of troponins in accelerated diagnostic pathways. Practical suggestions are made for laboratories regarding analytical quality assessment of cardiac troponin results at low cutoffs, with a particular focus on accelerated diagnostic pathways. The review also discusses how future use of cardiac troponins for long-term prediction or management of cardiovascular disease may require improvements in analytical quality.
Summary:
Clinical guidelines recommend using cardiac troponin concentrations as low as the limit of detection of the assay to guide patient care. Laboratories, manufacturers, researchers, and external quality assessment providers should extend analytical performance monitoring of cardiac troponin assays to include the concentration ranges applicable in these pathways.
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