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; Khosrow Adeli

doi:10.1515/cclm-2022-0709

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

Clin Chem Lab Med. 2022 Sep 19;61(1):123-132. doi: 10.1515/cclm-2022-0709. Print 2023 Jan 27.

Authors

Mary Kathryn Bohn^{1

2}, Siobhan Wilson^{1

2}, Randal Schneider³, Youssef Massamiri⁴, Edward W Randell⁴, Khosrow Adeli^{1

2}

Affiliations

¹ CALIPER Program, Molecular Medicine, Research Institute and the Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
² Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
³ Abbott Diagnostics, Abbott Park, IL, USA.
⁴ Clinical Biochemistry, Eastern Health Authority, St. John's, NL, Canada.

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.

MeSH terms

Adolescent
Anti-Citrullinated Protein Antibodies*
Child
Cohort Studies
Humans
Immunoassay
Male
Neoplasms* / diagnosis
Reference Values

Substances

Anti-Citrullinated Protein Antibodies