Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, which may result in infertility. Because of the complicated etiology and high morbidity, it has attracted wild attention of researchers around the world. The large quantity of blood specimens that have been obtained from multicenter clinical trials (PCOSAct) are precious resources for clinical research. It could not only contain clinical data of the related diseases but also provide vital guidance for the diagnosis and treatment of the disease. This paper discusses the collection, processing, storage, and testing of blood specimens as well as the potential problems, and emphasizes the importance of specimen quality for high quality clinical research. The purpose of this paper is to provide experience and reference for the standardized construction of biobank in future and improve the management of blood specimen in clinical trials.
Citation：
CONG Jing, WANG Guiyuan, WANG Huan, GAO Jingshu, KUANG Hongying, LI Wei, HUANG Jing, WU Xiaoke. Management strategy of blood specimen of a large sample size multicenter clinical trial of polycystic ovary syndrome. Chinese Journal of Evidence-Based Medicine, 2018, 18(1): 81-85. doi: 10.7507/1672-2531.201705002
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Copyright © the editorial department of Chinese Journal of Evidence-Based Medicine of West China Medical Publisher. All rights reserved
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Zhu C, Pinsky P, Huang WY, et al. Laboratory detective work identifies a mishandling problem in sample aliquoting. Biopreserv Biobank, 2014, 12(6): 430-432.
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Anton G, Wilson R, Yu ZH, et al. Pre-analytical sample quality: metabolite ratios as an intrinsic marker for prolonged room temperature exposure of serum samples. PLoS One, 2015, 10(3): e0121495.
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Ellis HJ, Venturini DS. Demonstration of a frozen sample aliquotter to prepare plasma and serum aliquots without thawing frozen parent samples. Biopreserv Biobank, 2013, 11(3): 153-160.
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Zander J, Bruegel M. Effect of biobanking conditions on short-term stability of biomarkers in human serum and plasma. Clin Chem Lab Med, 2014, 52(5): 629-639.
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Gislefoss RE, Grimsrud TK, MØrkrid L. Stability of selected serum hormones and lipids after long-term storage in the Janus Serum Bank. Clin Biochem, 2015, 48(6): 364-369.
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- 1. 杨瑞锋, 金茜, 费然, 等. 全国多中心临床试验样本收集与冷链运输的质量调查. 临床检验杂志, 2013, 31(3): 218-221.
- 2. 季加孚, 张连海, 张扬, 等. 生物样本库的能力建设与最佳实践. 北京: 科学出版社, 2013: 175.
- 3. Carraro P, Zago T, Plebani M. Exploring the initial steps of the testing process: frequency and nature of pre-preanalytic errors. Clin Chem, 2012, 58(3): 638-642.
- 4. Ellervik C, Vaught J. Preanalytical variables affecting the integrity of human biospecimens in biobanking. Clin Chem, 2015, 61(7): 914-934.
- 5. 沈文娟, 吴效科, 刘建平. 中医药多中心随机对照试验实施过程质量控制的经验体会. 现代中医临床, 2014, 21(3): 23-26.
- 6. Yin P, Peter A, Franken H, et al. Preanalytical aspects and sample quality assessment in metabolomics studies of human blood. Clin Chem, 2013, 59(5): 833-845.
- 7. Zhu C, Pinsky P, Huang WY, et al. Laboratory detective work identifies a mishandling problem in sample aliquoting. Biopreserv Biobank, 2014, 12(6): 430-432.
- 8. Anton G, Wilson R, Yu ZH, et al. Pre-analytical sample quality: metabolite ratios as an intrinsic marker for prolonged room temperature exposure of serum samples. PLoS One, 2015, 10(3): e0121495.
- 9. Ellis HJ, Venturini DS. Demonstration of a frozen sample aliquotter to prepare plasma and serum aliquots without thawing frozen parent samples. Biopreserv Biobank, 2013, 11(3): 153-160.
- 10. Zander J, Bruegel M. Effect of biobanking conditions on short-term stability of biomarkers in human serum and plasma. Clin Chem Lab Med, 2014, 52(5): 629-639.
- 11. Gislefoss RE, Grimsrud TK, MØrkrid L. Stability of selected serum hormones and lipids after long-term storage in the Janus Serum Bank. Clin Biochem, 2015, 48(6): 364-369.
