[Cardiac troponin I and C: analytical comparison and clinical-biological interpretation of three troponins assays]
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C Bionda1, M Pettazzoni, C Rodriguez-Lafrasse
1Laboratoire de biochimie et biologie moléculaire, hôpital cardiovasculaire et pneumologique Louis-Pradel, Bron, France. clara.bionda@chu-lyon.fr
Insights
This study compared two cardiac troponin assays, AccuTnI and Troponin T STAT, for acute coronary syndromes. Both assays showed accurate analytical performance, with AccuTnI demonstrating better specificity and positive predictive value.
Area of Science:
- Clinical Chemistry
- Cardiovascular Diagnostics
- Biomarker Assay Evaluation
Background:
- Multiple generations of cardiac troponin I (cTnI) and T (cTnT) assays are available for concentration determination.
- Redefinition of upper reference values for acute coronary syndromes necessitates performance evaluation of current assays.
Purpose of the Study:
- To evaluate the clinical and analytical performance of two troponin assays: second-generation Troponin Ic (AccuTnI) and third-generation Troponin Tc (Troponin T STAT).
- To compare their accuracy, sensitivity, specificity, and predictive values against established methods and recommended decision values.
Main Methods:
- Analytical performance assessment of AccuTnI (Beckman Coulter Access 2) and Troponin T STAT (Roche Diagnostics Elecsys 2010) including sensitivity, repeatability, and reproducibility.
- Method comparison with Dade Behring assay (TROP) using Dimension RxL.
- Evaluation of clinical decision values for cTnI and cTnT, considering specificity and sensitivity trade-offs.
Main Results:
- Both AccuTnI and Troponin T STAT assays demonstrated accurate analytical performance.
- High correlation observed between AccuTnI and the Dade Behring assay (r = 0.99).
- AccuTnI exhibited better specificity (76%) and positive predictive value (89%) at a decision value of 0.1 microg/L, with 100% sensitivity.
- The recommended decision value for cTnT (0.1 microg/L) showed lower specificity compared to its published value, with some false positives/negatives noted in complex cases.
Conclusions:
- The AccuTnI assay shows strong analytical performance and clinical utility for diagnosing acute coronary syndromes.
- A decision value of 0.1 microg/L for cTnI provides a good balance between sensitivity and specificity.
- Careful consideration of clinical context is essential when interpreting cTnT results, especially in patients with complex pathologies, due to potential discrepancies.
Abstract:
Many assays 1(st), 2(nd) even 3(rd) generation are at present available to determine the concentration of cardiac troponin I and T. With the redefinition of upper reference value in the acute coronary syndromes, the aim of this study was to evaluate the clinical and analytical performance of 2 troponins assays: Troponin Ic 2(nd) generation (AccuTnI) on Access 2 of Beckman Coulter and Troponin Tc 3(rd)generation (Troponin T STAT) on Elecsys 2010 of Roche Diagnostics. The analytical performance observed with these 2 assays are accurate (analytical and functional sensitivity, repetability and reproductibility). Comparing each method with Dade Behring assay (Flex Troponine-I Cardiaque, TROP) on Dimension RxL, the correlation observed with AccuTnI kit on Access 2 can be put into the equation: AccuTnI = 1.08 (TnIc TROP) - 0.34, r = 0.99. On the contrary, it's more difficult to compare cTnI and cTnT. The study of decisonnal values indicated by Beckman Coulter for cTnI (0.04 microg/L at the 99 degrees percentil, 0.06 microg/L for a CV < or =10%) show a better specificity (76%) and predictive positive value (89%) with a sensitivity at 100% at 0.1 microg/L, fixed and used in the laboratory for its better agreement between sensibility / specificity and its imprecision below 10 %. For the cTnT values published by Roche Diagnostics (0.01 microg/L), at the 99 degrees percentil and 0.03 microg/L for a CV < or = 10%, the specificity is lower, so the decisionnal value 0.1 microg/L seems to be more suitable. During this study, few false positive and negative cTnT values have been observed, in patients with complex pathologies; this eventuality must be taken in consideration if clinical findings are not in good accordance with laboratory results.
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