癌胚抗原参考物质赋值的准确方法。
Accurate method for value assignment of carcinoembryonic antigen reference materials.
机构信息
Department of Clinical Laboratory, Beijing Chao-yang Hospital, Capital Medical University, Beijing, China.
Beijing Center for Clinical Laboratories, Beijing, China.
出版信息
J Clin Lab Anal. 2023 Jun;37(11-12):e24936. doi: 10.1002/jcla.24936. Epub 2023 Jul 3.
BACKGROUND
In this study, we explored the commutability of reference materials (RMs) for carcinoembryonic antigen (CEA), selected the appropriate diluent matrix of the first International Reference Preparation (IRP) 73/601 of the World Health Organization (WHO 73/601) for CEA, and improved the comparability of CEA measurement results among different assay systems.
METHODS
Forty serum samples were divided into five aliquots. WHO 73/601 was diluted into nine concentrations using five diluents with different components, and the candidate RMs for CEA at five concentrations (C1-C5) were prepared by the Beijing Clinical Laboratory Center (BCCL). The samples were analyzed via five automated CEA immunoassays.
RESULTS
Carcinoembryonic antigen candidate RMs were commutable among all immunoassays based on the CLSI approach and among 7 of 10 assay combinations based on the IFCC approach. WHO 73/601 diluted in phosphate-buffered saline (PBS) was commutable among all assays based on the CLSI approach and among 5 of 10 pairwise comparisons based on the IFCC approach with correction of bias at diluted concentrations, except for the lowest concentration, which had the smallest variation among systems. The median percentage biases among assays were decreased after calibration.
CONCLUSION
The BCCL candidate RMs (C2-C5) for CEA were commutable among all immunoassays. WHO 73/601 RMs diluted in a PBS buffer matrix were selected as common calibrators for five immunoassays, which reduced bias, thereby effectively improving the harmonization of CEA detection; therefore, they could be used to assign values to CEA candidate RMs developed by BCCL. Our findings promote the harmonization of CEA detection in immunoassays.
背景
本研究旨在探讨癌胚抗原（CEA）参考物质（RM）的互换性，选择世界卫生组织（WHO）第一国际参考制剂（IRP）73/601 的合适稀释基质，并改进不同检测系统中 CEA 检测结果的可比性。
方法
将 40 份血清样本分为 5 份。用含有不同成分的 5 种稀释液将 WHO 73/601 稀释至 9 个浓度，由北京临床检验中心（BCCL）制备 5 个浓度（C1-C5）的 CEA 候选 RM。使用 5 种自动化 CEA 免疫分析系统对样品进行分析。
结果
根据 CLSI 方法，所有免疫分析系统均认为 CEA 候选 RM 具有互换性；根据 IFCC 方法，7 种免疫分析系统中有 10 种组合具有互换性。基于 CLSI 方法，WHO 73/601 用磷酸盐缓冲液（PBS）稀释后，所有免疫分析系统均具有互换性；基于 IFCC 方法，除了最低浓度外，在对稀释浓度进行偏倚校正后，5 种免疫分析系统中有 10 种组合具有互换性，且该浓度的变异最小。经过校准后，各检测系统间的中位数偏差百分比有所降低。
结论
BCCL 研制的 CEA 候选 RM（C2-C5）在所有免疫分析系统中具有互换性。选用 PBS 缓冲液基质稀释的 WHO 73/601 RM 作为 5 种免疫分析系统的共同校准品，降低了偏倚，从而有效提高了 CEA 检测的协调性；因此，这些 RM 可用于赋值给 BCCL 研制的 CEA 候选 RM。本研究结果促进了 CEA 免疫检测的协调一致。
Zotero 插件