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Licensed Unlicensed Requires Authentication Published by De Gruyter August 5, 2019

Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents

Mary Kathryn Bohn, Victoria Higgins, Shervin Asgari, Felix Leung, Barry Hoffman, Joseph Macri and Khosrow Adeli

Abstract

Background

The diagnostic utility of laboratory tests in paediatric medicine relies heavily on the availability of appropriate reference intervals (RIs). The Canadian Laboratory Initiative on Paediatric Reference Intervals (CALIPER) has established a comprehensive database of covariate-stratified RIs for many paediatric laboratory tests using a large, healthy reference population. Several automated analysers in widespread use in clinical laboratories have already been studied. Here, we extend the testing to Roche immunoassays and report, for the first time, comprehensive paediatric RIs for 17 endocrine and special chemistry markers.

Methods

A total of 741 healthy children and adolescents (1 day to <19 years) were recruited and serum samples were analysed for 17 immunoassays on the Roche cobas 8000 e602 Immunoassay Analyzer. Age and sex-specific RIs were established and corresponding 90% confidence intervals (CIs) were calculated in accordance with Clinical and Laboratory Standards Institute guidelines.

Results

Reference values for all analytes measured required age partitioning, particularly during early life and throughout adolescence. Of the 17 analytes measured, eight required sex partitioning, including ferritin, thyroid stimulating hormone (TSH), total triiodothyronine (TT3) and all fertility/sex hormones, except prolactin.

Conclusions

This is the first study to determine accurate paediatric RIs for Roche immunoassays. RIs were generally similar to those previously published by CALIPER on other analytical platforms, highlighting the reproducibility of age- and sex-specific trends in reference values observed across the paediatric age range. The RIs established in this study will improve the accuracy of test result interpretation and clinical decision-making in clinical laboratories utilising Roche immunoassays.

Funding source: Canadian Institutes of Health Research

Award Identifier / Grant number: 353989

Funding statement: The study was financially supported by a Foundation Grant from the Canadian Institutes of Health Research (CIHR, Funder Id: http://dx.doi.org/10.13039/501100000024, Grant Number: 353989) as well as a research grant and material support from Roche Diagnostics Canada. M.K. Bohn was supported by the Restracomp SickKids Scholarship.

Acknowledgments

This study would not have been possible without the generous participation of children from the community. We thank all participants, their families and the numerous CALIPER volunteers whose dedication and time commitment made this study possible. We would also like to thank technical and managerial staff at Mount Sinai Hospital for analysis of paediatric samples on the Roche cobas systems.

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

  2. Employment or leadership: None declared.

  3. Honorarium: None declared.

  4. 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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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2019-0707).


Received: 2019-07-11
Accepted: 2019-07-18
Published Online: 2019-08-05
Published in Print: 2019-11-26

© 2019 Walter de Gruyter GmbH, Berlin/Boston

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