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.
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.
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.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Informed consent was obtained from all individuals included in this study.
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).
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