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Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents

  • Mary Kathryn Bohn , Siobhan Wilson , Randal Schneider , Youssef Massamiri , Edward W. Randell and Khosrow Adeli EMAIL logo
Published/Copyright: September 19, 2022
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Clinical Chemistry and Laboratory Medicine (CCLM)
From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 1

Abstract

Objectives

Clinical laboratory investigation of autoimmune, metabolic, and oncologic disorders in children and adolescents relies on appropriateness of reference intervals (RIs). The Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) previously established comprehensive pediatric RIs for specialized immunoassays on the Abbott ARCHITECT system. Herein, we aim to verify performance on new Alinity i assays by evaluating sera collected from healthy children as per Clinical and Laboratory Standards Institute (CLSI) EP-28A3C guidelines.

Methods

Precision, linearity, and method comparison experiments were completed for 17 specialized Alinity immunoassays, including cancer antigens, autoimmune peptides, and hormones. Sera collected from healthy children and adolescents (birth-18 years, n=100) were evaluated. CLSI-based verification was completed using previously established CALIPER RIs for ARCHITECT assays as the reference.

Results

Of 17 specialized immunoassays assays, only anti-cyclic citrullinated peptides (anti-CCP) did not meet acceptable verification criterion (i.e., ≥90% of results within ARCHITECT reference CI). Anti-thyroglobulin, anti-thyroid peroxidase, and carcinoembryonic antigen did not require age-specific consideration beyond one year of age, with 63, 91, and 80% of samples equalling the limit of detection, respectively. Estimates were separated by sex for relevant assays (e.g., sex hormone binding globulin, total and free prostate specific antigen).

Conclusions

Findings support transferability of pediatric RIs on ARCHITECT system to the Alinity system for 16 specialized immunoassays in the CALIPER cohort and will be a useful resource for pediatric clinical laboratories using Alinity assays. Further work is needed to establish evidence-based interpretative recommendations for anti-CCP and continue to evaluate pediatric RI acceptability for newly available assay technologies.

Keywords: Abbott Alinity; CALIPER; pediatric reference interval; specialized immunoassay; verification
Corresponding author: Khosrow Adeli, CALIPER Program, Molecular Medicine, Research Institute and the Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, 555 University Avenue, Toronto, ON, M5G 1X8 Canada; and Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada, Phone: 416-813-8682, E-mail:

Funding source: Canadian Institutes of Health Research

Award Identifier / Grant number: 353989

Funding source: Abbott Diagnostics

Acknowledgments

We would like to thank CALIPER participants and families without whom this work would not have been possible. We would also like to thank Dr. Vathany Kulasingam (University Hospital Network, Toronto, ON, Canada) and Dr. Amy Lou (Nova Scotia Health, Halifax, NS, Canada) for their assistance with method comparison analysis. We would like to acknowledge Abbott Diagnostics for providing reagent and funding support.

  1. Research funding: This work was supported by a Canadian Institutes for Health Research (CIHR) Foundation Grant, a research grant from Abbott Diagnostics USA, a CIHR Doctoral Scholarship (awarded to Mary Kathryn Bohn), and a CIHR Masters Scholarship and a Banting and Best Diabetes Centre Graduate Studentship (awarded to Siobhan Wilson).

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

  3. Competing interests: Authors state no conflict of interest.

  4. Informed consent: Informed consent was obtained from all individuals included in this study.

  5. Ethical approval: Study was approved by the Research Ethics Board at The Hospital for Sick Children.

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Supplementary Material

The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2022-0709).

Received: 2022-07-21
Accepted: 2022-09-09
Published Online: 2022-09-19
Published in Print: 2023-01-27

© 2022 Walter de Gruyter GmbH, Berlin/Boston

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. A new milestone on the road to global standardization of apolipoprotein measurements
  4. Review
  5. Saliva – a new opportunity for fluid biopsy
  6. Opinion Papers
  7. Emerging technology: a definition for laboratory medicine
  8. The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance
  9. EFLM Paper
  10. The new, race-free, Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation to estimate glomerular filtration rate: is it applicable in Europe? A position statement by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
  11. Guidelines and Recommendations
  12. Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results
  13. General Clinical Chemistry and Laboratory Medicine
  14. Quantitative protein mass-spectrometry requires a standardized pre-analytical phase
  15. Report from the HarmoSter study: inter-laboratory comparison of LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone
  16. The influence of proteoforms: assessing the accuracy of total vitamin D-binding protein quantification by proteolysis and LC-MS/MS
  17. Total serum vitamin B12 (cobalamin) LC-MS/MS assay as an arbiter of clinically discordant immunoassay results
  18. The preanalytical process in the emergency department, a European survey
  19. Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements
  20. Umbilical cord blood gases: probability of arterial or venous source in acidemia
  21. Reference Values and Biological Variations
  22. Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents
  23. Hematology and Coagulation
  24. Performance of digital morphology analyzer CellaVision DC-1
  25. Cancer Diagnostics
  26. Managing the impact of inter-method bias of prostate specific antigen assays on biopsy referral: the key to move towards precision health in prostate cancer management
  27. Cardiovascular Diseases
  28. Quantitation of cardiac troponin I in cancer patients treated with immune checkpoint inhibitors: a case-control study
  29. Infectious Diseases
  30. A novel scoring system combining Modified Early Warning Score with biomarkers of monocyte distribution width, white blood cell counts, and neutrophil-to-lymphocyte ratio to improve early sepsis prediction in older adults
  31. Technical and health governance aspects of the External Quality Assessment Scheme for the SARS-CoV-2 molecular tests: institutional experience performed in all clinical laboratories of a Regional Health Service
  32. Acknowledgment
  33. Acknowledgment
  34. Letters to the Editor
  35. About the estimation of albuminuria based on proteinuria results
  36. Response to “About the estimation of albuminuria based on proteinuria results”
  37. Reply to Abildgaard et al.: lot variation and inter-device differences contribute to poor analytical performance of the DCA vantage™ HbA1c POCT instrument in a true clinical setting
  38. Reply to letter from Mayfield et al. regarding “Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting”
  39. High-sensitive cardiac troponin T: are turbulences coming?
  40. Analytical performance evaluation of bioactive adrenomedullin on point-of-care platform
  41. Increased PD-L1 surface expression on peripheral blood granulocytes and monocytes after vaccination with SARS-CoV2 mRNA or vector vaccine
  42. Neopterin level can be measured by intraocular liquid biopsy
  43. The stability of pleural fluid pH under slushed ice and room temperature conditions
https://doi.org/10.1515/cclm-2022-0709
Keywords for this article
Abbott Alinity; CALIPER; pediatric reference interval; specialized immunoassay; verification

Articles in the same Issue

  1. Frontmatter
  2. Editorial
  3. A new milestone on the road to global standardization of apolipoprotein measurements
  4. Review
  5. Saliva – a new opportunity for fluid biopsy
  6. Opinion Papers
  7. Emerging technology: a definition for laboratory medicine
  8. The next wave of innovation in laboratory automation: systems for auto-verification, quality control and specimen quality assurance
  9. EFLM Paper
  10. The new, race-free, Chronic Kidney Disease Epidemiology Consortium (CKD-EPI) equation to estimate glomerular filtration rate: is it applicable in Europe? A position statement by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)
  11. Guidelines and Recommendations
  12. Overcoming challenges regarding reference materials and regulations that influence global standardization of medical laboratory testing results
  13. General Clinical Chemistry and Laboratory Medicine
  14. Quantitative protein mass-spectrometry requires a standardized pre-analytical phase
  15. Report from the HarmoSter study: inter-laboratory comparison of LC-MS/MS measurements of corticosterone, 11-deoxycortisol and cortisone
  16. The influence of proteoforms: assessing the accuracy of total vitamin D-binding protein quantification by proteolysis and LC-MS/MS
  17. Total serum vitamin B12 (cobalamin) LC-MS/MS assay as an arbiter of clinically discordant immunoassay results
  18. The preanalytical process in the emergency department, a European survey
  19. Proenkephalin A as a marker for glomerular filtration rate in critically ill children: validation against gold standard iohexol GFR measurements
  20. Umbilical cord blood gases: probability of arterial or venous source in acidemia
  21. Reference Values and Biological Variations
  22. Pediatric reference interval verification for 17 specialized immunoassays and cancer markers on the Abbott Alinity i system in the CALIPER cohort of healthy children and adolescents
  23. Hematology and Coagulation
  24. Performance of digital morphology analyzer CellaVision DC-1
  25. Cancer Diagnostics
  26. Managing the impact of inter-method bias of prostate specific antigen assays on biopsy referral: the key to move towards precision health in prostate cancer management
  27. Cardiovascular Diseases
  28. Quantitation of cardiac troponin I in cancer patients treated with immune checkpoint inhibitors: a case-control study
  29. Infectious Diseases
  30. A novel scoring system combining Modified Early Warning Score with biomarkers of monocyte distribution width, white blood cell counts, and neutrophil-to-lymphocyte ratio to improve early sepsis prediction in older adults
  31. Technical and health governance aspects of the External Quality Assessment Scheme for the SARS-CoV-2 molecular tests: institutional experience performed in all clinical laboratories of a Regional Health Service
  32. Acknowledgment
  33. Acknowledgment
  34. Letters to the Editor
  35. About the estimation of albuminuria based on proteinuria results
  36. Response to “About the estimation of albuminuria based on proteinuria results”
  37. Reply to Abildgaard et al.: lot variation and inter-device differences contribute to poor analytical performance of the DCA vantage™ HbA1c POCT instrument in a true clinical setting
  38. Reply to letter from Mayfield et al. regarding “Lot variation and inter-device differences contribute to poor analytical performance of the DCA Vantage™ HbA1c POCT instrument in a true clinical setting”
  39. High-sensitive cardiac troponin T: are turbulences coming?
  40. Analytical performance evaluation of bioactive adrenomedullin on point-of-care platform
  41. Increased PD-L1 surface expression on peripheral blood granulocytes and monocytes after vaccination with SARS-CoV2 mRNA or vector vaccine
  42. Neopterin level can be measured by intraocular liquid biopsy
  43. The stability of pleural fluid pH under slushed ice and room temperature conditions
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