Startseite Pediatric reference value distributions and covariate-stratified reference intervals for 29 endocrine and special chemistry biomarkers on the Beckman Coulter Immunoassay Systems: a CALIPER study of healthy community children
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Pediatric reference value distributions and covariate-stratified reference intervals for 29 endocrine and special chemistry biomarkers on the Beckman Coulter Immunoassay Systems: a CALIPER study of healthy community children

  • Kimiya Karbasy , Danny C.C. Lin , Alexandra Stoianov , Man Khun Chan , Victoria Bevilacqua , Yunqi Chen und Khosrow Adeli EMAIL logo
Veröffentlicht/Copyright: 10. Oktober 2015
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Clinical Chemistry and Laboratory Medicine (CCLM)
Aus der Zeitschrift Clinical Chemistry and Laboratory Medicine (CCLM) Band 54 Heft 4

Abstract

Background: The CALIPER program is a national research initiative aimed at closing the gaps in pediatric reference intervals. CALIPER previously reported reference intervals for endocrine and special chemistry markers on Abbott immunoassays. We now report new pediatric reference intervals for immunoassays on the Beckman Coulter Immunoassay Systems and assess platform-specific differences in reference values.

Methods: A total of 711 healthy children and adolescents from birth to <19 years of age were recruited from the community. Serum samples were collected for measurement of 29 biomarkers on the Beckman Coulter Immunoassay Systems. Statistically relevant age and/or gender-based partitions were determined, outliers removed, and reference intervals calculated in accordance with Clinical and Laboratory Standards Institute (CLSI) EP28-A3c guidelines.

Results: Complex profiles were observed for all 29 analytes, necessitating unique age and/or sex-specific partitions. Overall, changes in analyte concentrations observed over the course of development were similar to trends previously reported, and are consistent with biochemical and physiological changes that occur during childhood. Marked differences were observed for some assays including progesterone, luteinizing hormone and follicle-stimulating hormone where reference intervals were higher than those reported on Abbott immunoassays and parathyroid hormone where intervals were lower.

Conclusions: This study highlights the importance of determining reference intervals specific for each analytical platform. The CALIPER Pediatric Reference Interval database will enable accurate diagnosis and laboratory assessment of children monitored by Beckman Coulter Immunoassay Systems in health care institutions worldwide. These reference intervals must however be validated by individual labs for the local pediatric population as recommended by CLSI.

Keywords: immunoassays; pediatrics; reference intervals
Corresponding author: Khosrow Adeli, Clinical Biochemistry, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8 Canada, E-mail: ; CALIPER program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada; and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada
aKimiya Karbasy and Danny C.C. Lin contributed equally to this study.

Acknowledgments

We thank all of the CALIPER participants and their families; this study would not have been possible without their participation. We also thank the CALIPER coordinators, and all of the CALIPER volunteers for their hard work in participant recruitment and sample collection. Lastly, we acknowledge Dr. Jack Zakowski for his critical review of the manuscript, and the Beckman Coulter staff for their sample analysis work.

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

Research funding: This study was supported by an operating grant from the CIHR (Canadian Institutes of Health Research) and Beckman Coulter, Inc.

Employment or leadership: None declared.

Honorarium: None declared.

Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Supplemental Material:

The online version of this article (DOI: 10.1515/cclm-2015-0558) offers supplementary material, available to authorized users.

Received: 2015-6-12
Accepted: 2015-8-27
Published Online: 2015-10-10
Published in Print: 2016-4-1

©2016 by De Gruyter

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https://doi.org/10.1515/cclm-2015-0558
Schlagwörter für diesen Artikel
immunoassays; pediatrics; reference intervals

Artikel in diesem Heft

  1. Frontmatter
  2. Editorial
  3. Macroprolactin: searching for a needle in a haystack?
  4. Review
  5. Laboratory medicine in the new healthcare environment
  6. Opinion Paper
  7. Developing GRADE outcome-based recommendations about diagnostic tests: a key role in laboratory medicine policies
  8. EFLM Survey
  9. Accreditation process in European countries – an EFLM survey
  10. Genetics and Molecular Diagnostics
  11. HB Puerta del Sol [HBA1:c.148A>C], HB Valdecilla [HBA2:c.3G>T], HB Gran Vía [HBA2:c.98T>G], HB Macarena [HBA2:c.358C>T] and HB El Retiro [HBA2:c.364_366dupGTG]: description of five new hemoglobinopathies
  12. General Clinical Chemistry and Laboratory Medicine
  13. A candidate reference method using ICP-MS for sweat chloride quantification
  14. Quantification of hemoglobin A1c by off-line HPLC separation and liquid chromatography-tandem mass spectrometry: a modification of the IFCC reference measurement procedure
  15. Comparison between B·R·A·H·M·S PCT direct, a new sensitive point-of-care testing device for rapid quantification of procalcitonin in emergency department patients and established reference methods – a prospective multinational trial
  16. Evaluation of a hand-held blood gas analyzer for rapid determination of blood gases, electrolytes and metabolites in intensive care setting
  17. Use of a faecal immunochemical test for haemoglobin can aid in the investigation of patients with lower abdominal symptoms
  18. A possible cause of the variable detectability of macroprolactin by different immunoassay systems
  19. A multicenter comparison of whole blood vitamin B6 assays
  20. Analytical and clinical performance of the new Fujirebio 25-OH vitamin D assay, a comparison with liquid chromatography-tandem mass spectrometry (LC-MS/MS) and three other automated assays
  21. Development and validation of a 2nd tier test for identification of purine nucleoside phosphorylase deficiency patients during expanded newborn screening by liquid chromatography-tandem mass spectrometry
  22. A cross-sectional study of biomarkers of exposure and effect in smokers and moist snuff consumers
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  26. Birth season predicts the values of red blood cell distribution width (RDW) in adulthood
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  42. Analytical evaluation of a second generation assay for chromogranin A; a dual-site study
  43. UBE3A, c.1347_1348delGA: a mutation in question
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