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Biochem Med (Zagreb). 2020 Jun 15;30(2):020101. doi: 10.11613/BM.2020.020101. Epub 2020 Apr 15.
3
[Recommendations for the application and the follow-up of quality controls in medical biology laboratories].[医学生物学实验室质量控制的应用与后续建议]
Ann Biol Clin (Paris). 2019 Oct 1;77(5):577-597. doi: 10.1684/abc.2019.1481.
4
High-sensitivity cardiac troponin-I analytical imprecisions evaluated by internal quality control or imprecision profile.通过内部质量控制或不精密度概况评估高敏心肌肌钙蛋白I的分析不精密度。
Clin Chem Lab Med. 2019 Mar 26;57(4):e49-e51. doi: 10.1515/cclm-2018-0529.
5
The role of external quality assessment in the verification of in vitro medical diagnostics in the traceability era.体外诊断溯源时代外部质量评估在体外医学诊断验证中的作用
Clin Biochem. 2018 Jul;57:23-28. doi: 10.1016/j.clinbiochem.2018.02.004. Epub 2018 Feb 9.
6
IFCC Working Group Recommendations for Assessing Commutability Part 2: Using the Difference in Bias between a Reference Material and Clinical Samples.IFCC 工作组关于评估可比性的建议 第 2 部分:使用参考物质和临床样本之间的偏倚差异。
Clin Chem. 2018 Mar;64(3):455-464. doi: 10.1373/clinchem.2017.277541. Epub 2018 Jan 18.
7
IFCC Working Group Recommendations for Assessing Commutability Part 3: Using the Calibration Effectiveness of a Reference Material.IFCC 工作组关于评估等效性的建议 第 3 部分:使用参考物质的校准有效性。
Clin Chem. 2018 Mar;64(3):465-474. doi: 10.1373/clinchem.2017.277558. Epub 2018 Jan 18.
8
IFCC Working Group Recommendations for Assessing Commutability Part 1: General Experimental Design.国际临床化学联合会工作组关于评估可比性的建议 第 1 部分:一般实验设计。
Clin Chem. 2018 Mar;64(3):447-454. doi: 10.1373/clinchem.2017.277525. Epub 2018 Jan 18.
9
Analytical performance specifications for external quality assessment - definitions and descriptions.外部质量评估的分析性能规范——定义与描述。
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10
Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain.在意大利、荷兰、葡萄牙、英国和西班牙的EQA组织者开展的INPUtS项目中,17种常规化学分析物在不同国家和不同制造商之间的分析性能。
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如何在医学实验室认可过程中真正理解并完善内部质量控制和外部质量评估体系?

How to Really Understand and Improve the System of Internal Quality Control and External Quality Assessment in the Accreditation Process of the Medical Laboratory?

作者信息

Skitek Milan, Martinello Flávia, Jerin Aleš

机构信息

University Medical Centre Ljubljana, Clinical Institute of Clinical Chemistry and Biochemistry, Ljubljana, Slovenia.

Department of Clinical Analysis, Federal University of Santa Catarina, Florianopolis, Brazil.

出版信息

EJIFCC. 2022 Apr 11;33(1):23-27. eCollection 2022 Apr.

PMID:35645692
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9092718/
Abstract

Internal quality control (IQC) regarding process to monitor analytical stability has a long tradition in laboratory medicine. The satisfactory results with different quality specifications of the IQC ensure the acceptability of the examination results. Although the statistical IQC is satisfactory some problems exist, resulting in unreliable patients' results due several reasons (non-commutable control materials, lot to lot difference of reagents, false interpreting test results regarding autovalidation or autoverification, different analytical and clinical specifications or goals etc.). Therefore, the results and findings of IQC have to be connected with external quality assessment (EQA) in order to provide the system of measurement of uncertainty (MU) with correct interpretation of laboratory result and detection relevant and significant shifts and drifts in medical laboratory.

摘要

关于监测分析稳定性过程的内部质量控制(IQC)在检验医学中有着悠久的传统。IQC不同质量规格的满意结果确保了检验结果的可接受性。尽管统计性IQC令人满意,但仍存在一些问题,由于多种原因(不可互换的控制材料、试剂批次间差异、关于自动验证或自动核查的测试结果错误解读、不同的分析和临床规格或目标等)导致患者结果不可靠。因此,IQC的结果和发现必须与外部质量评估(EQA)相联系,以便为测量不确定度(MU)系统提供对实验室结果的正确解读,并检测医学实验室中相关且显著的偏移和漂移。