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能力验证/外部质量评估:当前的挑战和未来的方向。

Proficiency testing/external quality assessment: current challenges and future directions.

机构信息

Virginia Commonwealth University, Richmond, VA, USA

出版信息

Clin Chem. 2011 Dec;57(12):1670-80. doi: 10.1373/clinchem.2011.168641. Epub 2011 Sep 30.

DOI:10.1373/clinchem.2011.168641
PMID:21965556
Abstract

BACKGROUND

Proficiency testing (PT), or external quality assessment (EQA), is intended to verify on a recurring basis that laboratory results conform to expectations for the quality required for patient care.

CONTENT

Key factors for interpreting PT/EQA results are knowledge of the commutability of the samples used and the process used for target value assignment. A commutable PT/EQA sample demonstrates the same numeric relationship between different measurement procedures as that expected for patients' samples. Noncommutable PT/EQA samples frequently have a matrix-related bias of unknown magnitude that limits interpretation of results. PT/EQA results for commutable samples can be used to assess accuracy against a reference measurement procedure or a designated comparison method. In addition, the agreement of the results between different measurement procedures for commutable samples reflects that which would be seen for patients' samples. PT/EQA results for noncommutable samples must be compared to a peer group mean/median of results from participants who use measurement procedures that are expected to have the same or very similar matrix-related bias. Peer group evaluation is used to asses whether a laboratory is using a measurement procedure in conformance to the manufacturer's specifications and/or in conformance to other laboratories using the same technology. A noncommutable PT/EQA sample does not give meaningful information about the relationship of results for patients' samples between different measurement procedures.

SUMMARY

PT/EQA provides substantial value to the practice of laboratory medicine by assessing the performance of individual laboratories and, when commutable samples are used, the status of standardization or harmonization among different measurement procedures.

摘要

背景

能力验证(PT)或外部质量评估(EQA)旨在定期验证实验室结果是否符合患者护理所需质量的预期。

内容

解释 PT/EQA 结果的关键因素是了解所用样本的可互换性以及目标值赋值所使用的过程。可互换的 PT/EQA 样本在不同测量程序之间表现出与患者样本相同的数值关系。不可互换的 PT/EQA 样本通常具有未知大小的基质相关偏倚,限制了结果的解释。可互换样本的 PT/EQA 结果可用于评估与参考测量程序或指定比较方法的准确性。此外,可互换样本不同测量程序之间的结果一致性反映了患者样本的情况。不可互换样本的 PT/EQA 结果必须与使用预期具有相同或非常相似基质相关偏倚的测量程序的参与者的同行组平均值/中位数进行比较。同行组评估用于评估实验室是否按照制造商的规格使用测量程序,以及(或)是否符合使用相同技术的其他实验室。不可互换的 PT/EQA 样本不能提供关于不同测量程序之间患者样本结果关系的有意义信息。

总结

PT/EQA 通过评估单个实验室的性能以及在使用可互换样本时评估不同测量程序之间的标准化或协调状态,为实验室医学实践提供了重要价值。

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