Can Reference Materials Prepared Following CLSI C37-A Be Utilized Without Commutability Assessment? Perspectives Based on Lipid Measurements.

IF 3.9 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Jong Do Seo, Gye Cheol Kwon, Jeong-Ho Kim, Sang-Guk Lee, Junghan Song, Pil-Whan Park, Dongheui An, Qute Choi, Chan-Ik Cho, Sollip Kim, Yeo-Min Yun
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引用次数: 0

Abstract

Background: Ensuring reference material (RM) commutability is crucial for evaluating measurement traceability in order to standardize laboratory tests. However, commutability assessment is not routinely performed. We assessed whether RMs prepared following CLSI C37-A guidelines could be used without assessing commutability by evaluating their commutability for four lipid measurements using the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) and CLSI EP14 protocols.

Methods: We analyzed total cholesterol (TC), triglycerides (TGs), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) in frozen sera from 20 individuals and 11 RMs, prepared by the Korea Disease Control and Prevention Agency-Laboratory Standardization Project (per CLSI C37-A), using six routine measurement procedures (MPs). Regression equations and 95% prediction intervals derived from single-donor sera were analyzed following CLSI EP14. The IFCC protocol was used to assess differences in inter-MP biases between RM and clinical samples. The effect of the TG concentration on commutability was evaluated by analyzing biases between MP results and reference procedure-assigned values.

Results: RMs were commutable for most MP pairs for TC and TG. Commutability for HDL-C and LDL-C varied across RMs, with RM10 and RM11 showing higher TG levels (2.38 and 2.95 mmol/L, respectively) and lower commutability. Increased bias percentages from assigned values were observed for RMs with higher TG levels.

Conclusions: RMs prepared per CLSI C37-A were commutable with most MP pairs for TC and TG. Elevated TG levels affected HDL-C and LDL-C commutability, highlighting the need to consider TG concentrations during RM preparation and assess commutability to standardize laboratory tests.

按照CLSI C37-A标准制备的参考材料可以不进行可交换性评估而使用吗?基于脂质测量的观点。
背景:为了标准化实验室测试,确保标准物质(RM)的可交换性对于评估测量可追溯性至关重要。然而,可交换性评估并不是例行进行的。我们通过使用国际临床化学和检验医学联合会(IFCC)和CLSI EP14方案评估四种脂质测量的可交换性,评估按照CLSI C37-A指南制备的RMs是否可以在不评估可交换性的情况下使用。方法:采用6种常规测量方法(MPs),对韩国疾病预防控制院实验室标准化项目(CLSI C37-A)制备的20名个体和11名对照者的冷冻血清中总胆固醇(TC)、甘油三酯(tg)、高密度脂蛋白胆固醇(HDL-C)和低密度脂蛋白胆固醇(LDL-C)进行分析。采用CLSI EP14分析单供者血清的回归方程和95%预测区间。IFCC方案用于评估RM和临床样本之间mp间偏倚的差异。TG浓度对可交换性的影响通过分析MP结果与参考程序分配值之间的偏差来评估。结果:TC和TG的大多数MP对均方根是可交换的。HDL-C和LDL-C的可交换性在RM10和RM11中表现出较高的TG水平(分别为2.38和2.95 mmol/L)和较低的可交换性。对于TG水平较高的均方根值,观察到分配值的偏倚百分比增加。结论:CLSI C37-A制备的RMs与大多数MP对的TC和TG可互换。升高的TG水平影响HDL-C和LDL-C的可交换性,强调在RM制备过程中需要考虑TG浓度并评估可交换性以标准化实验室测试。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Annals of Laboratory Medicine
Annals of Laboratory Medicine MEDICAL LABORATORY TECHNOLOGY-
CiteScore
8.30
自引率
12.20%
发文量
100
审稿时长
6-12 weeks
期刊介绍: Annals of Laboratory Medicine is the official journal of Korean Society for Laboratory Medicine. The journal title has been recently changed from the Korean Journal of Laboratory Medicine (ISSN, 1598-6535) from the January issue of 2012. The JCR 2017 Impact factor of Ann Lab Med was 1.916.
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