Mosca Andrea, Paleari Renata
Centre for Metrological Traceability in Laboratory Medicine (CIRME), Dept. of Physiopatholgy and Transplantation, Università degli Studi di Milano, Milano, Italy.
Centre for Metrological Traceability in Laboratory Medicine (CIRME), Dept. of Physiopatholgy and Transplantation, Università degli Studi di Milano, Milano, Italy.
Clin Biochem. 2018 Jul;57:29-36. doi: 10.1016/j.clinbiochem.2018.05.018. Epub 2018 May 29.
This article wants to focus on the today available Reference Measurement Procedures (RMPs) for the determination of various analytes in Laboratory Medicine and the possible tools to evaluate their performance in the laboratories who are currently using them.
A brief review on the RMPs has been performed by investigating the Joint Committee for Traceability in Laboratory Medicine (JCTLM) database. In order to evaluate their performances, we have checked the organization of three international ring trials, i.e. those regularly performed by the IFCC External Quality assessment scheme for Reference Laboratories in Laboratory Medicine (RELA), by the Center for Disease Control and Prevention (CDC) cholesterol network and by the IFCC Network for HbA.
Several RMPs are available through the JCTLM database, but the best way to collect information about the RMPs and their uncertainties is to look at the reference measurement service providers (RMS). This part of the database and the background on how to listed in the database is very helpful for the assessment of expanded uncertainty (MU) and performance in general of RMPs. Worldwide, 17 RMS are listed in the database, and for most of the measurands more than one RMS is able to run the relative RMPs, with similar expanded uncertainties. As an example, for a-amylase, 4 SP offer their services with MU between 1.6 and 3.3%. In other cases (such as total cholesterol, the U may span over a broader range, i.e. from 0.02 to 3.6%). With regard to the performance evaluation, the approach is often heterogenous, and it is difficult to compare the performance of laboratories running the same RMP for the same measurand if involved in more than one EQAS.
The reference measurement services have been created to help laboratory professionals and manufacturers to implement the correct metrological traceability, and the JCTLM database is the only correct way to retrieve all the necessary important information to this end.
本文旨在聚焦于当前实验室医学中用于测定各种分析物的参考测量程序（RMP），以及评估其在正在使用这些程序的实验室中性能的可能工具。
通过调查实验室医学溯源联合委员会（JCTLM）数据库，对RMP进行了简要回顾。为了评估其性能，我们检查了三项国际环形试验的组织情况，即国际临床化学和检验医学联合会（IFCC）医学实验室参考实验室外部质量评估计划（RELA）、疾病控制与预防中心（CDC）胆固醇网络以及IFCC糖化血红蛋白网络定期开展的试验。
通过JCTLM数据库可获取多种RMP，但收集有关RMP及其不确定度信息的最佳方式是查看参考测量服务提供商（RMS）。数据库的这一部分以及如何列入数据库的背景信息，对于评估RMP的扩展不确定度（MU）和总体性能非常有帮助。在全球范围内，数据库中列出了17个RMS，对于大多数被测量物，有多个RMS能够运行相关的RMP，且扩展不确定度相似。例如，对于α淀粉酶，4个服务提供商提供的服务其MU在1.6%至3.3%之间。在其他情况下（如总胆固醇），不确定度范围可能更广，即从0.02%至3.6%。关于性能评估，方法往往各不相同，如果参与多个外部质量评估计划（EQAS），则难以比较运行相同RMP测定相同被测量物的实验室的性能。
创建参考测量服务是为了帮助实验室专业人员和制造商实现正确的计量溯源，而JCTLM数据库是为此检索所有必要重要信息的唯一正确途径。
