当前位置: X-MOL 学术Clin. Chem. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Optimizing Available Tools for Achieving Result Standardization: Value Added by Joint Committee on Traceability in Laboratory Medicine (JCTLM)
Clinical Chemistry ( IF 9.3 ) Pub Date : 2021-10-11 , DOI: 10.1093/clinchem/hvab178
Mauro Panteghini 1 , Federica Braga 1 , Johanna E Camara 2 , Vincent Delatour 3 , Katleen Van Uytfanghe 4 , Hubert W Vesper 5 , Tianjiao Zhang 6 ,
Affiliation  

Abstract
Background
The JCTLM created a Task Force on Reference Measurement System Implementation (TF-RMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community.
Content
TF-RMSI investigated the reference measurement systems (RMS) for 13 common measurands by applying the following procedural steps: (a) extracting data from the JCTLM database of available certified reference materials (CRMs) and reference measurement procedures (RMPs); (b) describing the RMS to which each recruited CRM or RMP belongs; (c) identifying the intended use of the CRMs, and, if used as a common calibrator for IVD measuring systems and/or trueness assessment of field methods was included, checking the CRM’s certificate for information about commutability with clinical samples; and (d) checking if the CRM or RMP measurement uncertainty (MU) has the potential to be small enough to avoid significantly affecting the analytical performance specifications (APS) for MU of clinical sample results when the MU from the IVD calibrator and from the end-user measuring system were combined.
Summary
We produced a synopsis of JCTLM-listed higher-order CRMs and RMPs for the selected measurands, including their main characteristics for implementing traceability and fulfilling (or not) the APS for suitable MU. Results showed that traceability to higher-order references can be established by IVD manufacturers within the defined APS for most of the 13 selected measurands. However, some measurands do not yet have suitable CRMs for use as common calibrators. For these measurands, splitting clinical samples with a laboratory performing the RMP may provide a practical alternative for establishing a calibration hierarchy.


中文翻译:

优化实现结果标准化的可用工具:检验医学可追溯性联合委员会 (JCTLM) 的附加值

摘要
背景
JCTLM 创建了一个参考测量系统实施工作组 (TF-RMSI),为体外诊断 (IVD) 社区的计量可追溯性实施提供指导。
内容
TF-RMSI 通过应用以下程序步骤研究了 13 个常见被测量的参考测量系统 (RMS): ( a ) 从可用的认证参考材料 (CRM) 和参考测量程序 (RMP) 的 JCTLM 数据库中提取数据;( b ) 描述每个招募的 CRM 或 RMP 所属的 RMS;( c ) 确定 CRM 的预期用途,如果用作体外诊断测量系统的通用校准器和/或包括现场方法的正确性评估,则检查 CRM 的证书以获取与临床样本可互换性的信息;和 ( d) 检查 CRM 或 RMP 测量不确定度 (MU) 是否有可能足够小以避免显着影响临床样本结果的 MU 的分析性能规范 (APS)系统相结合。
概括
我们为选定的被测量生成了 JCTLM 列出的高阶 CRM 和 RMP 的概要,包括它们用于实现可追溯性和满足(或不满足)适用于 MU 的 APS 的主要特征。结果表明,IVD 制造商可以在定义的 APS 内为 13 个选定的被测量中的大多数建立对高阶参考的可追溯性。然而,一些被测量还没有合适的 CRM 用作通用校准器。对于这些被测量,将临床样本与执行 RMP 的实验室分开可以为建立校准层次结构提供一种实用的替代方法。
更新日期:2021-10-15
down
wechat
bug