External quality assessment for the molecular detection of microsatellite instability in China, 2021-2022.

IF 3.9 3区医学 Q1 PATHOLOGY Expert Review of Molecular Diagnostics Pub Date : 2023-07-01 Epub Date: 2023-09-12 DOI:10.1080/14737159.2023.2257133

Xiaoyu Fan, Qianming Bai, Chunli Shi, Yanqun Xiao, Xueliang Wang

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引用次数: 0

Abstract

Background: Microsatellite instability (MSI) analysis of tumors informs Lynch syndrome testing, therapeutic choice, and prognosis. The status of MSI is mainly detected by polymerase chain reaction coupled with capillary electrophoresis. However, there are various assays with different detection loci and the obtained results may vary. The objective of this study was to evaluate the concordance among different assays and the performance among different laboratories.

Methods: External quality assessment (EQA) for the detection of MSI was performed in 2021 and 2022. Each sample panel consisted of five samples, including microsatellite-stable and MSI tumor tissues. The sample panels were coded at random, and the returned results were compared and scored.

Results: The fully validated sample panels showed appropriate applicability with commercially available assays. There were eight false-negative results in 2021 and five false results (two false-positives and three false-negatives) in 2022. Among the participating laboratories, in 2021, 20 (74.07%) provided completely correct results; in 2022, 38 (92.68%) obtained an optimal score.

Conclusion: The molecular detection of MSI in China exhibited an improvement in a 2-year EQA study. Participation in EQA program is an efficient way of assessing the performance of laboratories and improving their ability.

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2021-2022年中国微卫星不稳定性分子检测的外部质量评估。

背景：肿瘤的微卫星不稳定性（MSI）分析为林奇综合征的检测、治疗选择和预后提供了依据。MSI的状态主要通过聚合酶链式反应结合毛细管电泳来检测。然而，存在具有不同检测基因座的各种测定，并且所获得的结果可能不同。本研究的目的是评估不同测定之间的一致性以及不同实验室之间的性能。方法：于2021年和2022年进行MSI检测的外部质量评估（EQA）。每个样本组由五个样本组成，包括微卫星稳定和MSI肿瘤组织。随机对样本面板进行编码，并对返回的结果进行比较和评分。结果：经过充分验证的样品板在商业上可获得的分析中显示出适当的适用性。2021年有8个假阴性结果，2022年有5个假阳性结果（2个假阳性和3个假阴性）。在参与的实验室中，2021年，有20个（74.07%）提供了完全正确的结果；2022年，38人（92.68%）获得了最佳分数。结论：在2年的EQA研究中，中国MSI的分子检测有了改进。参与EQA项目是评估实验室绩效和提高实验室能力的有效途径。

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来源期刊

Expert Review of Molecular Diagnostics 医学-病理学

CiteScore

6.60

自引率

0.00%

发文量

审稿时长

1 months

期刊介绍： Expert Review of Molecular Diagnostics (ISSN 1473-7159) publishes expert reviews of the latest advancements in the field of molecular diagnostics including the detection and monitoring of the molecular causes of disease that are being translated into groundbreaking diagnostic and prognostic technologies to be used in the clinical diagnostic setting. Each issue of Expert Review of Molecular Diagnostics contains leading reviews on current and emerging topics relating to molecular diagnostics, subject to a rigorous peer review process; editorials discussing contentious issues in the field; diagnostic profiles featuring independent, expert evaluations of diagnostic tests; meeting reports of recent molecular diagnostics conferences and key paper evaluations featuring assessments of significant, recently published articles from specialists in molecular diagnostic therapy. Expert Review of Molecular Diagnostics provides the forum for reporting the critical advances being made in this ever-expanding field, as well as the major challenges ahead in their clinical implementation. The journal delivers this information in concise, at-a-glance article formats: invaluable to a time-constrained community.