Comprehensive Pediatric Reference Limits for High-Sensitivity Cardiac Troponin I and NT-proBNP in the CALIPER Cohort
Mary Kathryn Bohn1,2, Khosrow Adeli1,2
1CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Insights
Establishing pediatric reference limits for cardiac biomarkers N-terminal (NT)-pro hormone brain natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI) is crucial. This study provides these vital limits for healthy children and adolescents, aiding clinical decisions.
Area of Science:
- Pediatric Cardiology
- Clinical Diagnostics
- Biomarker Analysis
Background:
- Cardiac biomarkers are increasingly used in pediatric care for conditions like heart failure.
- Existing evidence gaps in pediatric reference limits hinder accurate clinical decision-making.
- This study addresses the need for established pediatric reference limits for key cardiac biomarkers.
Purpose of the Study:
- To establish comprehensive pediatric reference limits for NT-proBNP and hs-cTnI.
- To provide data for accurate interpretation of cardiac biomarker levels in children and adolescents.
- To support informed clinical decision-making in pediatric cardiology.
Main Methods:
- Analyzed approximately 200 serum samples from healthy children (birth to 18 years).
- Measured N-terminal (NT)-pro hormone brain natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI) using Abbott Alinity immunoassays.
- Established reference limits (2.5th, 97.5th, 99th percentiles) following CLSI guidelines.
Main Results:
- 46% of pediatric samples showed detectable hs-cTnI levels.
- Markedly elevated neonatal concentrations observed for both hs-cTnI (99th percentile: 55.8 ng/L) and NT-proBNP (99th percentile: 1785 ng/L).
- No significant age- or sex-specific differences found beyond one year of age.
Conclusions:
- First report of age-specific reference limits for hs-cTnI and NT-proBNP in a healthy Canadian pediatric cohort.
- Data highlights the necessity for pediatric-specific interpretation of cardiac biomarkers.
- Calls for larger cohort studies to further solidify reference limits and improve clinical practice.
Background:
Cardiac biomarkers have increasing application in pediatric populations, including congenital heart disease, myocarditis, and heart failure. Clinical practice is limited by evidence gaps in pediatric reference limits to inform clinical decision-making. The current study aimed to establish comprehensive pediatric reference limits for N-terminal (NT)-pro hormone brain natriuretic peptide (NT-proBNP) and high-sensitivity cardiac troponin I (hs-cTnI) in the CALIPER cohort of healthy children and adolescents.
Methods:
Analytical immunoassay performance was assessed through precision, linearity, and method comparison (Abbott Alinity ci system). Subsequently, approximately 200 serum samples collected from apparently healthy children (birth to 18 years) were analyzed for hs-cTnI and NT-proBNP. Reference limits (2.5th, 97.5th, and 99th percentiles) were established as per Clinical and Laboratory Standards Institute EP-28A3c guidelines with associated 90% confidence intervals.
Results:
Of all pediatric serum samples analyzed, 46% had detectable hs-cTnI concentrations (limit of detection: 1.3 ng/L). Both hs-cTnI and NT-proBNP demonstrated markedly elevated neonatal concentrations with 99th percentiles of 55.8 and 1785 ng/L, respectively. No statistically significant age-specific differences were observed beyond 1 year of age across all cardiac biomarkers examined. No sex-specific association was observed between hs-cTnI and NT-proBNP concentration and adolescence.
Conclusions:
We report age-specific reference limits for hs-cTnI and NT-proBNP in a healthy Canadian cohort of children and adolescents measured using Alinity immunoassays for the first time. These data support the need for pediatric-specific interpretation to reduce misinformed clinical decision-making and calls to action larger cohort studies such that reference limits can be more robustly defined.
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