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Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents

An erratum for this article can be found here: https://doi.org/10.1515/cclm-2020-0041
  • Victoria Higgins , Angela W.S. Fung , Man Khun Chan , Joseph Macri and Khosrow Adeli EMAIL logo
Published/Copyright: July 19, 2017
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 56 Issue 2

Abstract

Background:

Accurate reference intervals (RIs) based on a healthy pediatric population are essential for pediatric test result interpretation. The CALIPER project has recruited a large healthy cohort and completed a series of a priori studies to address gaps in pediatric RIs. As immunoassays from different manufacturers for endocrine and special chemistry markers are not standardized and show marked intermethod differences, direct RI studies are needed for each major analytical platform. Here, we report age- and sex-specific pediatric RIs for 29 immunoassays on the Ortho Clinical Diagnostics (Ortho) VITROS® 5600 analyzer.

Methods:

Health information and blood samples were collected from healthy pediatric subjects. Using the Ortho VITROS 5600 Integrated System MicroWell Technology, 29 biomarkers were measured. Analyte concentrations were partitioned by age and sex according to the Harris and Boyd method. After removing outliers, age- and sex-specific RIs and corresponding 90% confidence intervals were calculated according to CLSI guidelines.

Results:

All analytes required age partitioning except β-human chorionic gonadotropin (β-hCG), cancer antigen 15-3 (CA15-3), rubella immunoglobulin G (rubella IgG), and vitamin D. Several analytes including estradiol, progesterone, testosterone, follicle-stimulating hormone (FSH), luteinizing hormone (LH), free triiodothyronine (FT3), total triiodothyronine (TT3), total thyroxine (TT4), thyroid uptake, ferritin, intact parathyroid hormone (iPTH), total prostate-specific antigen (tPSA), free prostate-specific antigen (fPSA), cancer antigen 125 (CA125), creatine kinase MB (CK-MB), and myoglobin showed sex differences, observed mostly with the onset of puberty.

Conclusions:

Complex reference value trends were observed across the pediatric age range for several biomarkers examined on Ortho VITROS immunoassays. The availability of VITROS immunoassay RIs will enable accurate laboratory test interpretation and diagnosis for the pediatric population. As recommended by the CLSI EP28-A3c guidelines, implementation of these RIs should be validated for each laboratory’s local pediatric population.

Keywords: immunoassays; pediatric; reference intervals

Acknowledgments

We thank all the participants and their families for their participation. We would also like to thank Dr. Maria Patru from Ortho Clinical Diagnostics (OCD) for critical review of the manuscript.

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

  2. Research funding: This study was supported by operating grants from the Canadian Institutes of Health Research (CIHR) (grant/award number: 353989) as well as a study grant from OCD to KA. The Ortho VITROS 5600 reagents used in the study were provided by OCD.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. 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 offers supplementary material (https://doi.org/10.1515/cclm-2017-0349).

Received: 2017-04-21
Accepted: 2017-06-06
Published Online: 2017-07-19
Published in Print: 2018-01-26

©2018 Walter de Gruyter GmbH, Berlin/Boston

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https://doi.org/10.1515/cclm-2017-0349
Keywords for this article
immunoassays; pediatric; reference intervals

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. Need for better PTH assays for clinical research and patient treatment
  4. Reviews
  5. Liquid biopsy in ovarian cancer: recent advances on circulating tumor cells and circulating tumor DNA
  6. Hair testing of GHB: an everlasting issue in forensic toxicology
  7. Opinion Paper
  8. The use of error and uncertainty methods in the medical laboratory
  9. Genetics and Molecular Diagnostics
  10. Results of the first external quality assessment scheme (EQA) for isolation and analysis of circulating tumour DNA (ctDNA)
  11. The importance of biochemical and genetic findings in the diagnosis of atypical Norrie disease
  12. General Clinical Chemistry and Laboratory Medicine
  13. Various glycolysis inhibitor-containing tubes for glucose measurement cannot be used interchangeably due to clinically unacceptable biases between them
  14. Measurement uncertainty of γ-glutamyltransferase (GGT) in human serum by four approaches using different quality assessment data
  15. Oxidation of PTH: in vivo feature or effect of preanalytical conditions?
  16. A comparison between high resolution serum protein electrophoresis and screening immunofixation for the detection of monoclonal gammopathies in serum
  17. The key incident monitoring and management system – history and role in quality improvement
  18. Is it necessary for all samples to quantify 25OHD2 and 25OHD3 using LC-MS/MS in clinical practice?
  19. Contamination of dried blood spots – an underestimated risk in newborn screening
  20. Comparative study of the diagnostic and prognostic value of antibodies against chimeric citrullinated synthetic peptides and CCP3/CCP3.1 assays
  21. Development and validation of a multivariable prediction rule for detecting a severe acquired ADAMTS13 activity deficiency in patients with thrombotic microangiopathies
  22. Use of the sFlt-1/PlGF ratio to rule out preeclampsia requiring delivery in women with suspected disease. Is the evidence reproducible?
  23. Evaluation of a new free light chain ELISA assay: bringing coherence with electrophoretic methods
  24. Hematology and Coagulation
  25. The frequency of occurrence of fish-shaped red blood cells in different haematologic disorders
  26. Reference Values and Biological Variations
  27. Pediatric reference intervals for 29 Ortho VITROS 5600 immunoassays using the CALIPER cohort of healthy children and adolescents
  28. Cancer Diagnostics
  29. Prevalence and causes of abnormal PSA recovery
  30. Cardiovascular Diseases
  31. Serum omentin-1 is a novel biomarker for predicting the functional outcome of acute ischemic stroke patients
  32. Letters to the Editor
  33. BD Vacutainer® Barricor tube in the emergency department: reduced hemolysis rates using partial draw tubes with reduced vacuum
  34. The risk of unjustified BRCA testing after the “Angelina Jolie effect”: how can we save (laboratory) medicine from the Internet?
  35. Sweat travels: the issue of sweat chloride transportation
  36. Individual values of antineutrophil cytoplasmic antibodies do not correspond between antigen-specific assays
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  38. Quantification of 1,25-dihydroxyvitamin D – value of manufacturers’ product information
  39. Interference between ethosuximide and barbiturates in an immunochromatographic method
  40. In vivo interference of Ioversol in serum and urine capillary electrophoresis: an optimized protocol for sample collection
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  44. ACBI 2017 40TH Annual Conference
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