Home Medicine Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
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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 EMAIL logo
Published/Copyright: August 5, 2019
Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 57 Issue 12

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.

Keywords: CALIPER; immunoassays; paediatric; reference intervals

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

Articles in the same Issue

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  2. Editorial
  3. The re-emergence of dried blood spot sampling – are we ready?
  4. Review
  5. The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
  6. Opinion Paper
  7. Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
  8. Guidelines and Recommendations from Scientific Societies
  9. A protocol for testing the stability of biochemical analytes. Technical document
  10. Genetics and Molecular Diagnostics
  11. Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
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  18. Heparin and citrate additive carryover during blood collection
  19. Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
  20. Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
  21. Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
  22. Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
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  24. A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
  25. EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
  26. Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
  27. Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
  28. Hematology and Coagulation
  29. Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
  30. Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
  31. Cardiovascular Diseases
  32. Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
  33. Infectious Diseases
  34. Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
  35. Letters to the Editor
  36. Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
  37. Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
  38. Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
  39. An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
  40. Utility of the icteric index for the management of bilirubin test requesting
  41. Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
  42. Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
  43. Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
  44. Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
  45. Congress Abstracts
  46. 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
https://doi.org/10.1515/cclm-2019-0707
Keywords for this article
CALIPER; immunoassays; paediatric; reference intervals

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. The re-emergence of dried blood spot sampling – are we ready?
  4. Review
  5. The role of platelets in bleeding in patients with thrombocytopenia and hematological disease
  6. Opinion Paper
  7. Exertional hematuria: definition, epidemiology, diagnostic and clinical considerations
  8. Guidelines and Recommendations from Scientific Societies
  9. A protocol for testing the stability of biochemical analytes. Technical document
  10. Genetics and Molecular Diagnostics
  11. Hereditary hyperferritinaemia-cataract syndrome (HHCS) – an underestimated condition: ferritin light chain variant spectrum in German families
  12. General Clinical Chemistry and Laboratory Medicine
  13. Performance of a web-based application measuring spot quality in dried blood spot sampling
  14. Clinical application of a dried blood spot assay for sirolimus and everolimus in transplant patients
  15. Plasma and dried blood spot lysosphingolipids for the diagnosis of different sphingolipidoses: a comparative study
  16. Liquid biopsy of cerebrospinal fluid identifies neuronal pentraxin receptor (NPTXR) as a biomarker of progression of Alzheimer’s disease
  17. Integrity of serum samples is changed by modified centrifugation conditions
  18. Heparin and citrate additive carryover during blood collection
  19. Copeptin – a biomarker of short-term mortality risk (7 days) in patients with end-stage liver disease
  20. Comparison of a new rapid method for the determination of adalimumab serum levels with two established ELISA kits
  21. Measurement of α-dicarbonyl compounds in human saliva by pre-column derivatization HPLC
  22. Establishment of the intelligent verification criteria for a routine urinalysis analyzer in a multi-center study
  23. Reference Values and Biological Variations
  24. A new indirect estimation of reference intervals: truncated minimum chi-square (TMC) approach
  25. EGFR and EGFR ligands in serum in healthy women; reference intervals and age dependency
  26. Early pregnancy reference intervals; 29 serum analytes from 4 to 12 weeks’ gestation in naturally conceived and uncomplicated pregnancies resulting in live births
  27. Paediatric reference intervals for 17 Roche cobas 8000 e602 immunoassays in the CALIPER cohort of healthy children and adolescents
  28. Hematology and Coagulation
  29. Study of the analytical performance at different concentrations of hematological parameters using Spanish EQAS data
  30. Multicenter performance evaluation of the Abbott Alinity hq hematology analyzer
  31. Cardiovascular Diseases
  32. Fast 0/1-h algorithm for detection of NSTEMI: are current high-sensitivity cardiac troponin assays fit for purpose? An EQA-based evaluation
  33. Infectious Diseases
  34. Diagnostic performance of cerebrospinal fluid free light chains in Lyme neuroborreliosis – a pilot study
  35. Letters to the Editor
  36. Quality management at the national biobanking level – establishing a culture of mutual trust and support: the BBMRI.at example
  37. Molecular diagnosis of MODY3 permitted to reveal a de novo 12q24.31 deletion and to explain a complex phenotype in a young diabetic patient
  38. Increased C-reactive protein values in the absence of inflammation: monoclonal immunoglobulin interference in immunonephelometry
  39. An approach based on simulated hemolysis for establishing the hemolysis index threshold for high-sensitivity cardiac troponin T assay
  40. Utility of the icteric index for the management of bilirubin test requesting
  41. Quality control of monocyte volume and distribution width parameters of the Beckman Coulter DxH series
  42. Mozhaisk haemoglobin variant effects on leukocyte differential channel using the Sysmex XN series
  43. Detection of a novel hemoglobin variant Hb Liaoning by matrix assisted laser desorption/ionization-time of flight mass spectrometry
  44. Appropriateness of repetitive therapeutic drug monitoring and laboratory turnaround time
  45. Congress Abstracts
  46. 51th National Congress of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC – Laboratory Medicine)
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