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
Author:
Bohn Mary Kathryn12, Wilson Siobhan12, Schneider Randal3, Massamiri Youssef4, Randell Edward W.4, Adeli Khosrow12
Affiliation:
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
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.
Publisher
Walter de Gruyter GmbH
Subject
Biochemistry (medical),Clinical Biochemistry,General Medicine
Reference40 articles.
1. Adeli, K, Higgins, V, Trajcevski, K, Palmert, MR. Important considerations for interpreting biochemical tests in children. BMJ 2018;361:k1950. https://doi.org/10.1136/bmj.k1950. 2. Adeli, K, Higgins, V, Trajcevski, K, White-Al Habeeb, N. The Canadian laboratory initiative on pediatric reference intervals: a CALIPER white paper. Crit Rev Clin Lab Sci 2017;54:358–413. https://doi.org/10.1080/10408363.2017.1379945. 3. Hoq, M, Matthews, S, Karlaftis, V, Burgess, J, Cowley, J, Donath, S, et al.. Reference values for 30 common biochemistry analytes across 5 different analyzers in neonates and children 30 days to 18 years of age. Clin Chem 2019;65:1317–26. https://doi.org/10.1373/clinchem.2019.306431. 4. Karbasy, K, Ariadne, P, Gaglione, S, Nieuwesteeg, M, Adeli, K. Advances in pediatric reference intervals for biochemical markers: establishment of the caliper database in healthy children and adolescents. J Med Biochem 2015;34:23–30. 5. Zierk, J, Arzideh, F, Rechenauer, T, Haeckel, R, Rascher, W, Metzler, M, et al.. Age- and sex-specific dynamics in 22 hematologic and biochemical analytes from birth to adolescence. Clin Chem 2015;61:964–73. https://doi.org/10.1373/clinchem.2015.239731.
Cited by
1 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献
|
|