Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
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Joel Smith
,
Vasiliki Karlaftis
Abstract
Objectives
In adults, the elevation of cardiac troponin (cTn) above the 99th percentile upper reference limit defines myocardial injury. The use and interpretation of cTn in a paediatric population, however, is difficult given the 99th percentile for different assays is not well established. Using paediatric blood samples from healthy neonates, infants and children we derived continuous and partitioned 97.5th and 99th percentiles for the Ortho VITROS hs-TnI assay.
Methods
A total of 328 samples for infants, children and adolescents aged 0–17.8 years were obtained. Age partitioned reference limits were derived in accordance with CLSI EP28-A3C. Continuous reference limits were established as described previously by the HAPPI Kids Study team.
Results
hs-TnI as measured by the Ortho VITROS Assay is highly elevated above the adult 99th percentile at birth and declines to lower levels within the first 6 months of life. The 99th centile upper reference limit for ages 0–3 months was 72 ng/L (90% CI: 52–91) and 9 ng/L (90% CI: 5.2–17.4) for ages 3 months to 18 years. Continuous upper 99th centile reference limits were comparable.
Conclusions
Partitioned and continuous 99th percentiles for hs-TnI were derived for the new Ortho VITROS assay in healthy neonates and older children. This will assist clinicians to appropriately assess for the presence of myocardial injury in this population.
Acknowledgments
The authors thank staff of the Pathology Collection, Anaesthetic, Surgical, and Neonatal and Post-Natal Departments at the Royal Children’s Hospital, Royal Women’s Hospital, Northern Hospital, and Western Health–Sunshine Hospital, Melbourne. The authors also acknowledge the contribution of scientists and clinical biochemists at The Royal Children’s Hospital.
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Research funding: This study was funded by The Royal Children’s Hospital Foundation, with supplementary funding from Ortho Clinical Diagnostics.
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Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The study protocol was approved by The Royal Children’s Hospital, Melbourne, Australia Ethics in Human Research Committee (HREC) (HREC 34183 A).
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© 2022 Walter de Gruyter GmbH, Berlin/Boston
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Articles in the same Issue
- Frontmatter
- Editorials
- Clinical Chemistry and Laboratory Medicine: enjoying the present and assessing the future
- Rethinking internal quality control: the time is now
- Review
- Multi-omics analysis from archival neonatal dried blood spots: limitations and opportunities
- Opinion Papers
- ‘Penelope test’: a practical instrument for checking appropriateness of laboratory tests
- Interference by macroprolactin in assays for prolactin: will the In Vitro Diagnostics Regulation lead to a solution at last?
- EFLM Paper
- Efficiency, efficacy and subjective user satisfaction of alternative laboratory report formats. An investigation on behalf of the Working Group for Postanalytical Phase (WG-POST), of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
- General Clinical Chemistry and Laboratory Medicine
- Cross-reactivity in assays for prolactin and optimum screening policy for macroprolactinaemia
- Repository of intra- and inter-run variations of quantitative autoantibody assays: a European multicenter study
- Stability of direct renin concentration and plasma renin activity in EDTA whole blood and plasma at ambient and refrigerated temperatures from 0 to 72 hours
- Comparison of four different immunoassays and a rapid isotope-dilution liquid chromatography-tandem mass spectrometry assay for serum folate
- Analytical quality specifications in semen analysis according to the state of the current methodologies
- Reference Values and Biological Variations
- Short-term biological variation study of plasma hemophilia and thrombophilia parameters in a population of apparently healthy Caucasian adults
- First morning voided urinary gonadotropins in children: verification of method performance and establishment of reference intervals
- Derivation of sex and age-specific reference intervals for clinical chemistry analytes in healthy Ghanaian adults
- Cancer Diagnostics
- Serum free light chain analysis: persisting limitations with new kids on the block
- Cardiovascular Diseases
- Age partitioned and continuous upper reference limits for Ortho VITROS High Sensitivity Troponin I in a healthy paediatric cohort
- The predictive value of hemoglobin to creatinine ratio for contrast-induced nephropathy in percutaneous coronary interventions
- Infectious Diseases
- Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2
- Evaluation of a laboratory-based high-throughput SARS-CoV-2 antigen assay
- Presepsin levels in neonatal cord blood are not influenced by maternal SARS-CoV-2 infection
- Letters to the Editors
- How to evaluate fixed clinical QC limits vs. risk-based SQC strategies
- Reply to Westgard et al.: ‘Keep your eyes wide … as the present now will later be past’*
- Platelet phagocytosis by monocytes
- Early detection of Candida parapsilosis in peripheral blood as a result of a peripheral blood smear performed after cytographic changes on the Beckman Coulter UniCel DxH 800 hematology
- Pseudo-erythroblastosis on Sysmex XN hematology analyzers: a clue to Candida sepsis. Case report and literature review
- Covert poisoning with difenacoum: diagnosis and follow-up difficulties
- Comparison of Sebia Capillarys 3-OCTA with the Tosoh Bioscience HLC®-723G8 method for A1C testing with focus on analytical interferences and variant detection
