Abstract
Objectives
The cardiac biomarkers high sensitivity cardiac troponin I (hs-cTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) are utilised in paediatric healthcare for the diagnosis and prognostic assessment of many conditions including myocarditis, congenital heart disease, multisystem inflammatory syndrome in children (MIS-C) and heart failure. However, the standardised age-related reference intervals, 99th percentile cut-offs and clinical guidelines are not available, making the interpretation of these biomarkers challenging. This study aimed to generate normative data in a paediatric cohort for the Siemens Atellica® IM 1300 analyser.
Methods
Residual plasma samples were collected from children aged up to 17 years attending primary care and out-patient settings and with no apparent evidence of cardiac dysfunction, renal dysfunction or other confounders. Reference intervals were generated using the 2.5th–97.5th percentiles, and 99th percentile cut-offs determined according to CLSI EP28-A3c.
Results
Statistical analysis revealed that partitioning was not required for gender for either biomarker. The reference interval for hs-cTnI for children aged one month to 16 years (n=292, 146 females and 146 males) was <14 ng/L with a 99th percentile cut-off of 19 ng/L. The reference interval for NT-proBNP for children aged one month up to one year was <714 ng/L (n=14) and for children aged 1–16 years (n=339) was <295 ng/L.
Conclusions
This is the first paediatric reference interval data generated on the Siemens Atellica® solution. These reference intervals and 99th percentiles will inform clinical decisions in the paediatric cardiology setting.
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Research ethics: This study was approved by the CHI research and Ethics Committee (REC-122-22).
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Informed consent: Not applicable.
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Author contributions: JJB conceived the study. AA carried out the study and statistical analysis and drafted the manuscript. The authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: The authors state no conflict of interest.
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Research funding: None declared.
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Data availability: The raw data can be obtained on request from the corresponding author.
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Supplementary Material
This article contains supplementary material (https://doi.org/10.1515/cclm-2023-0977).
© 2024 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorial
- Analytical performance specifications – moving from models to practical recommendations
- Opinion Papers
- What the Milan conference has taught us about analytical performance specification model definition and measurand allocation
- The role of analytical performance specifications in international guidelines and standards dealing with metrological traceability in laboratory medicine
- How clinical laboratories select and use Analytical Performance Specifications (APS) in Italy
- Outcome-based analytical performance specifications: current status and future challenges
- Analytical performance specifications based on biological variation data – considerations, strengths and limitations
- State-of-the-art model for derivation of analytical performance specifications: how to define the highest level of analytical performance technically achievable
- Analytical performance specifications for combined uncertainty budget in the implementation of metrological traceability
- When bias becomes part of imprecision: how to use analytical performance specifications to determine acceptability of lot-lot variation and other sources of possibly unacceptable bias
- Using analytical performance specifications in a medical laboratory
- Issues in assessing analytical performance specifications in healthcare systems assembling multiple laboratories and measuring systems
- Applying the Milan models to setting analytical performance specifications – considering all the information
- Guidelines and Recommendations
- Recommendations for blood sampling in emergency departments from the European Society for Emergency Medicine (EUSEM), European Society for Emergency Nursing (EuSEN), and European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase. Executive summary
- General Clinical Chemistry and Laboratory Medicine
- Assessment of accuracy of laboratory testing results, relative to peer group consensus values in external quality control, by bivariate z-score analysis: the example of D-Dimer
- The stability of 65 biochemistry analytes in plasma, serum, and whole blood
- Assessment of the 2023 European Kidney Function Consortium (EKFC) equations in a Chinese adult population
- In vitro, in vivo metabolism and quantification of the novel synthetic opioid N-piperidinyl etonitazene (etonitazepipne)
- Quantification of blood glial fibrillary acidic protein using a second-generation microfluidic assay. Validation and comparative analysis with two established assays
- Association of prehospital lactate levels with base excess in various emergencies – a retrospective study
- Reference Values and Biological Variations
- Stability of ten serum tumor markers after one year of storage at −18°C
- Variations in tumor growth, intra-individual biological variability, and the interpretation of changes
- Cancer Diagnostics
- N-linked glycosylation of the M-protein variable region: glycoproteogenomics reveals a new layer of personalized complexity in multiple myeloma
- Cardiovascular Diseases
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- Infectious Diseases
- Fetal chronic hypoxia does not affect urinary presepsin levels in newborns at birth
- Letters to the Editor
- AWMF statement on medical services in laboratory diagnostics and pathology with regard to the IVDR
- An outline of measurement uncertainty of total protein in urine estimated according to the ISO Technical Specification 20914
- Early diagnosis of severe illness in an outpatient – the Sysmex XN’s neutrophil reactivity parameter
- Analytical and diagnostic performance of Theradiag i-Tracker assays on IDS-iSYS for infliximab and adalimumab therapeutic drug monitoring
- Improving the diagnosis of AATD with aid of serum protein electrophoresis: a prospective, multicentre, validation study
- Cerebrospinal fluid kappa free light chains in patients with tumefactive demyelination
- Diagnostic value of quantitative chemiluminescence immunoassay for anti-gp210 and anti-sp100 antibodies in primary biliary cholangitis