[1]李万莎,晋豆豆,张会英.临床检验样本稳定性研究方法的最新进展[J].现代检验医学杂志,2025,40(06):201-204.[doi:10.3969/j.issn.1671-7414.2025.06.037]
　LI Wansha,JIN Doudou,ZHANG Huiying.Recent Advances in Research Methods for the Sample Stability in Clinical Laboratory[J].Journal of Modern Laboratory Medicine,2025,40(06):201-204.[doi:10.3969/j.issn.1671-7414.2025.06.037]
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临床检验样本稳定性研究方法的最新进展()

《现代检验医学杂志》[ISSN:/CN:]

卷:
第40卷
期数:
2025年06期
页码:
201-204
栏目:
论著
出版日期:
2025-11-15

文章信息/Info

Title:
Recent Advances in Research Methods for the Sample Stability in Clinical Laboratory
文章编号:
1671-7414（2025）06-201-04
作者:
李万莎，晋豆豆，张会英
北京高博医院医学检验中心，北京 102200
Author(s):
LI Wansha，JIN Doudou，ZHANG Huiying
Medical Laboratory Center，Beijing Gobroad Hospital，Beijing 102200, China
关键词:
样本稳定性; 稳定限; 连续实验设计; 离散实验设计
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2025.06.037
文献标志码:
A
摘要:
随着国际标准对临床样本稳定性要求的日益严格，临床实验室对样本稳定性研究的需求显著增加。为确保实验室检验结果的准确性，开展样本稳定性相关的研究和验证工作显得尤为迫切。然而，目前国内外在临床检验样本稳定性研究方法缺乏统一标准。为了更好地推进临床检验项目的样本稳定性研究和验证，此综述通过查阅相关文献和指南，对样本稳定性研究方法的最新进展进行了归纳总结。建议在临床检验的样本稳定性研究中参考国际组织的指导建议，如欧洲临床化学和实验室医学联合会（EFLM）发布的稳定性研究报告清单及临床样本稳定性研究设计的建议，并结合临床实验室的实际情况，选择连续实验设计或离散实验设计进行研究。
Abstract:
With the increasingly stringent requirements of international standards for the stability of clinical samples, there has been a significant rise in clinical laboratories’demand for sample stability research. To ensure the accuracy of laboratory test results, conducting research and verification work related to sample stability has become particularly urgent. However, there is currently a lack of unified standards for clinical sample stability studies both domestically and internationally. In order to better promote the resach and validation of sample stability in clinical laboratroy projects, this review summarized the latest progress in sample stability research methods by reviewing relevant literature and guidelines. It recommends referencing guidance from international organizations in clinical sample stability studies, such as the cress checklist for reporting stability studies and the “recommendations for the design of stability studies for clinical samples” issued by the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Laboratories should select either continuous experimental design or discrete experimental design based on their practical circumstances when conducting such research.

参考文献/References:

[1] CORNES M, VERMEERSCH P, SIMUNDIC AM, et al. The final part of the CRESS trilogy-how to evaluate the quality of stability studies[J]. Clinical Chemistry Laboratory Medicine, 2024, 62(11): 2128-2139.
[2] International Organization for standardization.ISO 15189: Medical laboratories-requirements for quality and competence[S]. Geneva: Switzerland, International Organization for Standardization, 2022.
[3] European Parliament, Council of the European Union. Regulation (E.U.) 2017/746 of the European Parliament and of the Council of 5 april 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU [EB/OL]. (2019-05-03). https://eur-lex.europa.eu/legal-content/EN/TXT/ HT-ML/?uri=CELEX:02017R0746-20220128&from=EN.
[4] 北京市药品监督管理局, 临床化学体外诊断试剂(盒)产品技术审评规范 [EB/OL] (2018-06-26)https://yjj. beijing.gov.cn/yjj/zwgk20/tz7/7352731/index/html. Beijing Municipal Medical Products Administration, Tech-nical review guidelines for clinical chemistry in vitro diag-nostic reagent (Kit) products [EB/OL]. (2018-06-26)https://yjj.beijing.gov.cn/yjj/zwgk20/tz7/7352731/index/html.
[5] 中国合格评定国家认可委员会.CNAS-GL003:2018:能力验证样品均匀性和稳定性评价指南[EB/OL]. https://www.cnas.org.cn/rkfw/sys/rkyq/rkzn/art/2024/art_1543386447.html. China National Accreditation Service for Conformity Assess-ment (CNAS). CNAS-GL003:2018: Guidance on evaluating the homogeneity and stability of proficiency testing samples [EB/OL]. https://www.cnas.org.cn/rkfw/sys/rkyq/rkzn/art/2024/art_1543386447.html.
[6] 中华人民共和国国家卫生健康委员会.WS/T 360-2024:流式细胞术检测外周血淋巴细胞亚群指南 [EB/OL]. http://www.nhc.gov.cn/wjw/s9492/202404/4ea0d-963281343bab8886d9cde140f15.shtml. National Health Commission of the People’s Republic of China. WS/T 360-2024: Guidelines for flow cytometric detection of peripheral blood lymphocyte subsets [EB/OL]. http://www.nhc.gov.cn/wjw/s9492/202404/4ea0d-963281343bab8886d9cde140f15.shtml.
[7] WOOD B, JEVREMOVIC D, BENE M C, et al. Val-idation of cell-based fluorescence assays: practice guidelines from the ICSH and ICCS-Part V-assay per-formance criteria[J]. Cytometry .Part B, Clinical Cy-tometry, 2013, 84(5): 315-323.
[8] NOWATZKE W, WOOLF E. Best Practices during bio-analytical method validation for the characterization of assay reagents and the evaluation of analyte stability in assay standards, quality controls, and study samples[J]. the AAPS Journal, 2007, 9(2): E117-E122.
[9] FDA. Bioanalytical Method Validation Guidance for In-dustry [EB/OL]. (2018-05-25) [2019-11-23]. https://www. fda. gov/regulatory-information/search-fda-guidance-docu-ments/bioanalytical-method-validation-guidance-industry.
[10] 满素勤, 张雪, 原月梦, 等. 生物标志物免疫分析方法学验证难点：稳定性[J]. 药物评价研究, 2020, 43(11): 2340-2344. MAN S Q, ZHANG X, YUAN Y M, et al. Challenges in the methodological validation of immunoassays for biomarkers: stability [J]. Drug Evaluation Research, 2022, 43(11): 2340-2344.
[11] GOMEZ-RIOJA R, MEYER AV, CORNES M, et al. Recommendation for the design of stability studies on clinical specimens[J]. Clinical Chemistry and Laborato-ry Medicine, 2023, 61(10): 1708-1718.
[12] CORNES M, SIMUNDIC A M, CADAMURO J, et al. The CRESS checklist for reporting stability studies: on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) Working Group for the Preanalytical Phase (WG-PRE) [J]. Clinical Chemis-try and Laboratory Medicine, 2021, 59(1): 59-69.
[13] Clinical and Laboratory Standards Institate. CLSI document EP44-A4: Procedures for the handling and processing of blood specimens for common laboratory tests, approved guideline [S]. Wayne: PA, Clinical and Laboratory Standards Institute, 2010.
[14] U.S. department of health and human services, food and drug administration, Center for Drug Evaluation and Research (CDER),et al. Guidance for industry. Q1A(R2) stability testing of new drug substances and products[EB/OL]. https://www.fda.gov/media/71707/download.
[15] European Medicines Agency (EMA). Note for guidance on evaluation of stability data (CPMP/ICH/420/02). www.pharma.gally.ch/ich/q1e042002.pdf.
[16] Clinical and Laboratory Standards Institate. CLSI Ep25-A: Evaluation of stability of in vitro diagnostic reagents, approved guideline. [S]. Wayne: PA, Clinical and Laboratory Standards Institute, 2009.
[17] GOMEZ-RIOJA R, AMARO MS, DIAZ-GARZON J, et al. A protocol for testing the stability of biochemical analytes. Technical document[J]. Clinical Chemistry Laboratory Medicine, 2019, 57(12): 1829-1836.
[18] PUM J K W. Evaluating sample stability in the clinical laboratory with the help of linear and non-linear regres-sion analysis[J]. Clinical Chemistry Laboratory Medi-cine, 2020, 58(2):188-196.
[19] ZHOU J, FABROS A, LAM S J, et al. The stability of 65 biochemistry analytes in plasma, serum, and whole blood[J]. Clinical Chemistry Laboratory Medicine, 2024, 62(8):1557-1569.
[20] 中华人民共和国国家卫生健康委员会. 临床化学检验常用项目分析质量标准: WS/T403-2024[S]. http://www.nhc.gov.cn/wjw/s9492/202407/46335ac1e-27a4432bd1cf50eb9b09750.shtml. National Health Commission of the People’s Republic of China. Analytical quality standards for common clinical chemistry tests: WS/T403-2024[S]. http://www. nhc.gov.cn/wjw/s9492/202407/46335ac1e27a4432bd-1cf50eb9b09750.shtml.

备注/Memo

备注/Memo:
作者简介：李万莎（1983-），女，硕士研究生，主管检验技师，研究方向：血液肿瘤、电泳技术、临床检验质量控制，E-mail：lwstfb@126.com。
通讯作者：张会英（1955-），女，大专，主任检验技师，研究方向：实验室质量管理，E-mail：zhanghuiying945@163.com。
更新日期/Last Update: 2025-11-15