在 CALIPER 队列中对健康儿童和青少年进行 Abbott Alinity i 系统上的 17 种特种免疫分析和肿瘤标志物的儿科参考区间验证。
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.
机构信息
CALIPER Program, Molecular Medicine, Research Institute and the Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
出版信息
Clin Chem Lab Med. 2022 Sep 19;61(1):123-132. doi: 10.1515/cclm-2022-0709. Print 2023 Jan 27.
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.
目的
临床实验室对儿童和青少年的自身免疫、代谢和肿瘤疾病的研究依赖于参考区间（RI）的适当性。加拿大儿科参考区间实验室倡议（CALIPER）先前在 Abbott ARCHITECT 系统上建立了专门免疫测定的全面儿科 RI。在此，我们按照临床和实验室标准协会（CLSI）EP-28A3C 指南，通过评估来自健康儿童的血清来验证新的 Alinity i 测定的性能。
方法
对 17 种特殊的 Alinity 免疫测定进行了精密度、线性和方法比较实验，包括肿瘤标志物、自身免疫肽和激素。评估了来自健康儿童和青少年（出生至 18 岁，n=100）的血清。使用先前建立的 ARCHITECT 测定的 CALIPER RI 作为参考，完成了基于 CLSI 的验证。
结果
在 17 种特殊的免疫测定中，只有抗环瓜氨酸肽（anti-CCP）不符合可接受的验证标准（即，90%的结果在 ARCHITECT 参考范围内）。抗甲状腺球蛋白、抗甲状腺过氧化物酶和癌胚抗原除了 1 岁以上需要年龄特异性考虑外，分别有 63%、91%和 80%的样本达到检测限。对于相关测定（例如，性激素结合球蛋白、总前列腺特异抗原和游离前列腺特异抗原），按性别进行了估计。
结论
研究结果支持在 CALIPER 队列中，将 ARCHITECT 系统的儿科 RI 转移到 Alinity 系统，用于 16 种特殊免疫测定，这将为使用 Alinity 测定的儿科临床实验室提供有用的资源。需要进一步的工作来为抗 CCP 建立基于证据的解释性建议，并继续评估新的可用测定技术的儿科 RI 可接受性。
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