Analytical Issues Surrounding Troponin Assays

Challenges in Cardiovascular Medicine

October 2010

Definition of these analytical requirements places the responsibility on manufacturers to ensure that their assays have the necessary precision to permit use of the proposed cut-off (which is the 99th percentile). Presently, not all troponin assays perform equally well in clinical settings and commercially available assays cannot meet the 10% CV as noted in this table. However, manufacturers are responding and there are several assays either in development or awaiting FDA approval that meet the goals and are considered “high sensitivity” assays. Clinical laboratories should carefully consider the effect of imprecision on clinical decision making when implementing or choosing a new troponin assay.

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Current Troponin Assays

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Jump to section:

• Introduction
• Challenges in Cardiovascular Medicine
• Shades of Gray
• Cardiac Markers
• Troponin Elevations are Greater and Persist Over Longer Time Periods
• 2007 Universal Definition of MI1
• Serial Sampling
• Elevation of cTn in Patients Without Overt Ischemic Heart Disease¹
• Analytic Confusion: Sensitivity and Imprecision of cTn Assays
• Analytical Definitions (Related to Troponin)
• Current Troponin Assays
• Defining the 99th Percentile (Normal Population)
• Troponin T or Troponin I: Does it Matter?
• Is CK-MB Needed Anymore?
• Recommendations for Point-of-Care Cardiac Marker Testing^2,3
• Does POCT Make Any Difference?
• What About the High-Sensitive Troponin Assays?
• Why All the Hype for High-Sensitivity Troponin?
• Troponin Concentrations and Diagnostic Accuracy⁴
• How Sensitive Does Troponin Testing Really Need to Be?
• Current Mayo Cardiac Biomarker Panel
• Current Mayo Cardiac Biomarker Panel
• Conclusions
• References
• Questions?
• Disclosure