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[实验室间比对——外部质量保证的核心手段]

[Interlaboratory comparisons-a central means of external quality assurance].

作者信息

Jöhrens Korinna, Grassow Maja, Baretton Gustavo, Sperling Florian

机构信息

Institut für Pathologie, Universitätsklinikum Carl Gustav Carus Dresden, Fetscherstr. 74, 01307, Dresden, Deutschland.

Qualitätssicherungs-Initiative Pathologie QuIP GmbH, Berlin, Deutschland.

出版信息

Pathologie (Heidelb). 2022 Sep;43(5):346-350. doi: 10.1007/s00292-022-01102-3. Epub 2022 Aug 10.

DOI:10.1007/s00292-022-01102-3
PMID:35948656
Abstract

The precise performance of immunohistochemical and molecular examinations of diagnostic and predictive markers is essential for the further therapy of patients. Due to the increasing number of biomarkers and their detection at the immunohistochemical and molecular level in patient tissue, the pathology has a direct influence on the therapy of patients, which increases the value of external quality assurance (EQA). In pathology, various forms are available for this purpose, such as proficiency tests. The standards of both the certification and accreditation procedures of pathology require regular participation in EQA and a statement on the EQA policy of the institutes. The quality of an EQA depends on the scientific concept, the adequate selection of material, the evaluation concept, and the communication of results.

摘要

对诊断和预测标志物进行准确的免疫组织化学和分子检测,对患者的后续治疗至关重要。由于生物标志物数量不断增加,且在患者组织的免疫组织化学和分子水平上进行检测,病理学对患者治疗有直接影响,这增加了外部质量保证(EQA)的价值。在病理学中,为此有多种形式可供使用,如能力验证试验。病理学的认证和认可程序标准都要求定期参与EQA,并就各机构的EQA政策发表声明。EQA的质量取决于科学概念、材料的适当选择、评估概念以及结果的传达。

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EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA: results of a round robin trial.非小细胞肺癌组织及添加循环游离肿瘤DNA的血液样本的EGFR T790M突变检测:一项循环试验的结果
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Results of the first external quality assessment scheme (EQA) for isolation and analysis of circulating tumour DNA (ctDNA).首个用于循环肿瘤 DNA(ctDNA)分离和分析的外部质量评估计划(EQA)的结果。
Clin Chem Lab Med. 2018 Jan 26;56(2):220-228. doi: 10.1515/cclm-2017-0283.
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Evolution of Quality Assurance for Clinical Immunohistochemistry in the Era of Precision Medicine. Part 3: Technical Validation of Immunohistochemistry (IHC) Assays in Clinical IHC Laboratories.精准医学时代临床免疫组织化学质量保证的演变。第3部分:临床免疫组织化学实验室中免疫组织化学(IHC)检测的技术验证
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Appl Immunohistochem Mol Morphol. 2017 Jan;25(1):4-11. doi: 10.1097/PAI.0000000000000451.
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