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Pediatric reference intervals for endocrine markers and fertility hormones in healthy children and adolescents on the Siemens Healthineers Atellica immunoassay system

  • Mary Kathryn Bohn , Paul Horn , Donna League , Paul Steele , Alexandra Hall and Khosrow Adeli EMAIL logo
Published/Copyright: May 7, 2021
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 59 Issue 8

Abstract

Objectives

Rapid development in childhood and adolescence combined with lack of immunoassay standardization necessitates the establishment of age-, sex-, and assay-specific reference intervals for immunochemical markers. This study established reference intervals for 11 immunoassays on the new Siemens Healthineers Atellica® IM Analyzer in the healthy CALIPER cohort.

Methods

A total of 600 healthy participants (birth to 18 years) were recruited from the community, and serum samples were collected with informed consent. After sample analysis, age- and sex-specific differences were assessed, and outliers were removed. Reference intervals were established using the robust method (40–<120 participants) or nonparametric method (≥120 participants).

Results

Of the 11 immunoassays studied, nine required age partitioning (i.e., dehydroepiandrosterone-sulfate, estradiol, ferritin, folate, follicle-stimulating hormone, luteinizing hormone, progesterone, testosterone, vitamin B12), and seven required sex partitioning. Free thyroxine and thyroid-stimulating hormone demonstrated no significant age- and/or sex-specific differences.

Conclusions

Overall, the age- and sex-specific trends observed closely mirrored those previously reported by CALIPER on other platforms as well as other internationally recognized studies. However, established lower and upper limits demonstrated some discrepancies between published values from healthy cohorts on alternate analytical systems, highlighting differences between manufacturers and the need for platform-specific reference intervals for informed pediatric clinical decision-making.

Keywords: CALIPER; endocrine; fertility; pediatric; reference intervals; Siemens Atellica
Corresponding author: Khosrow Adeli, CALIPER Program, Department of Pediatric Laboratory Medicine, Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8, Canada; and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada, Phone: +416 813 8682, ext. 208682, E-mail:

Funding source: Canadian Institutes of Health Research

Award Identifier / Grant number: 353989

Acknowledgments

We would like to thank CALIPER participants and families without whom this study would not be possible. We would also like to thank Siemens Healthineers for their support of this study.

  1. Research funding: This work was supported by a Foundation Grant from the Canadian Institutes of Health Research (CIHR) (Grant 353989), and Restracomp Scholarship (Hospital for Sick Children) (to M.K.B.). Reagents were provided at no cost by Siemens Healthcare LTD. Study funders played no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication.

  2. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: This study was approved by the Research Ethics Board at the Hospital for Sick Children in Toronto, Canada.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2021-0050).

Received: 2021-01-12
Accepted: 2021-04-25
Published Online: 2021-05-07
Published in Print: 2021-07-27

© 2021 Walter de Gruyter GmbH, Berlin/Boston

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DOI:  doi.org/10.1515/cclm-2021-0050
Keywords for this article
CALIPER; endocrine; fertility; pediatric; reference intervals; Siemens Atellica

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Kinetics and biological characteristics of humoral response developing after SARS-CoV-2 infection: implications for vaccination
  4. Reviews
  5. The impact of interventions applied in primary care to optimize the use of laboratory tests: a systematic review
  6. Circulating tumor DNA (ctDNA) as a pan-cancer screening test: is it finally on the horizon?
  7. Opinion Paper
  8. Performance specifications for measurement uncertainty of common biochemical measurands according to Milan models
  9. General Clinical Chemistry and Laboratory Medicine
  10. Activity-based cost analysis of laboratory tests in clinical chemistry
  11. Audit of sweat chloride testing reveals analytical errors
  12. Comparison of different algorithms in laboratory diagnosis of alpha1-antitrypsin deficiency
  13. Interpretable machine learning model to detect chemically adulterated urine samples analyzed by high resolution mass spectrometry
  14. Prognostic role of Krebs von den Lungen-6 (KL-6) measurement in idiopathic pulmonary fibrosis: a systematic review and meta-analysis
  15. Evaluating chronic kidney disease in rural South Africa: comparing estimated glomerular filtration rate using point-of-care creatinine to iohexol measured GFR
  16. Reference Values and Biological Variations
  17. Pediatric reference intervals for endocrine markers and fertility hormones in healthy children and adolescents on the Siemens Healthineers Atellica immunoassay system
  18. Cardiovascular Diseases
  19. Independent and combined effects of biotin and hemolysis on high-sensitivity cardiac troponin assays
  20. Infectious Diseases
  21. Analytical and clinical performances of a SARS-CoV-2 S-RBD IgG assay: comparison with neutralization titers
  22. Clinical validation of the Siemens quantitative SARS-CoV-2 spike IgG assay (sCOVG) reveals improved sensitivity and a good correlation with virus neutralization titers
  23. Evaluation of the automated LIAISON® SARS-CoV-2 TrimericS IgG assay for the detection of circulating antibodies
  24. Lumipulse G SARS-CoV-2 Ag assay evaluation using clinical samples from different testing groups
  25. Letters to the Editors
  26. The impact of measurement uncertainty on the uncertainty of ordinal medical scores based on continuous quantitative laboratory results
  27. Effect of five different pneumatic tube carrier inserts on mechanical sample stress: a multicentre evaluation
  28. Critical role of pre-analytical aspects for the measurement of circulating calprotectin in serum or plasma as a biomarker for neutrophil-related inflammation
  29. Prospective serological evaluation of anti SARS-CoV-2 IgG and anti S1-RBD antibodies in a community outbreak
  30. Common laboratory tests as indicators of COVID-19 severity on admission at high altitude: a single-center retrospective study in Quito (ECUADOR)
  31. Protease-antiprotease imbalance in patients with severe COVID-19
  32. Iodine containing contrast media and urinary flow cytometry: an unknown interference in automated urine sediment analysis
  33. Prolymphocytic or Richter’s transformation of chronic lymphocytic leukemia?
  34. OGTT reproducibility in adults with impaired fasting glucose is nearly 65% with adoption of Italian SIBioC-SIPMeL recommendations
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