Effect of Repeat Measurements of High-Sensitivity Cardiac Troponin on the Same Sample Using the European Society of Cardiology 0-Hour/1-Hour or 2-Hour Algorithms for Early Rule-Out and Rule-In for Myocardial Infarction
Key result
Repeat testing of the same sample yielded analytical variation leading to reclassification of 14% of patients using the ESC 0/1-hour algorithm compared to 2% using the 2-hour algorithm.
Why the study?
Does the ESC 0/1-hour algorithm lead to higher misclassification rates compared to the 2-hour algorithm due to analytical variation of hs-cTnI assays in plasma samples?
Population
50 fresh centrifuged lithium heparin plasma samples
Comparison
European Society of Cardiology 0/1-hour… vs 2-hour algorithm
Design
Other
Follow-up
3.5 hours
Authors
Discussion
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Member takes
Implication
Analytical variation risks more reclassifications with 0/1-hour algorithm; leaves open questions on its diagnostic stability.
Structured PICO
Does the ESC 0/1-hour algorithm lead to higher misclassification rates compared to the 2-hour algorithm due to analytical variation of hs-cTnI assays in plasma samples?
P
Population
50 fresh centrifuged lithium heparin samples measured for hs-cTnI 3 times within 3.5 hours to evaluate analytical variation of early rule-out/rule-in algorithms.
E
Exposure
European Society of Cardiology (ESC) 0/1-hour algorithm for early rule-out and rule-in of myocardial infarction using high-sensitivity cardiac troponin I (hs-cTnI, Abbott Diagnostics)
C
Comparator
2-hour algorithm
O
Outcome
Misclassification rate associated with short-term analytical variation (3 measurements within 3.5 hours on the same sample)surrogate
Main Result
Absolute Event Rate: 14% vs 2%
Analytical variation in hs-cTnI assays may cause >10% misclassification with the ESC 0/1-hour algorithm, raising concerns about its clinical robustness compared to the 2-hour algorithm.
Limitations
- Pure analytical nature of the study substituting a single sample for repeated patient draws
- Pure analytical nature of the study (substitutes a single sample for repeated samples drawn from patients)
Cite This Study
Kavsak et al. (2017) conducted a letter in Myocardial infarction (n=50). ESC 0/1-hour algorithm vs. 2-hour algorithm was evaluated on Misclassification rate due to short-term analytical variation. Repeat testing of the same sample yielded analytical variation leading to reclassification of 14% of patients using the ESC 0/1-hour algorithm compared to 2% using the 2-hour algorithm.