[1]郝庆钦,高 云,许友山,等.β2-微球蛋白血清质控物的制备及评价[J].现代检验医学杂志,2018,33(02):154-156.[doi:10.3969/j.issn.1671-7414.2018.02.001]
　HAO Qing-qin,GAO Yun,XU You-shan,et al.Preparation and Evaluation of the Serum Quality Control Material of β2-Microglobulin[J].Journal of Modern Laboratory Medicine,2018,33(02):154-156.[doi:10.3969/j.issn.1671-7414.2018.02.001]
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β2-微球蛋白血清质控物的制备及评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第33卷
期数:
2018年02期
页码:
154-156
栏目:
质量控制·实验室管理
出版日期:
2018-04-05

文章信息/Info

Title:
Preparation and Evaluation of the Serum Quality Control Material of β2-Microglobulin
文章编号:
1671-7414(2018)02-154-03
作者:
郝庆钦1; 高 云2; 许友山1; 钱惠忠1
1.无锡市红十字中心血站检验科,江苏无锡 214000; 2.河南省肿瘤医院/郑州大学附属肿瘤医院检验科,郑州 450008
Author(s):
HAO Qing-qin1; GAO Yun2; XU You-shan1; QIAN Hui-zhong1
1.Department of Clinical Laboratory,Wuxi Red Cross Blood Center, Jiangsu Wuxi 214000,China; 2.Department of Clinical Laboratory,the Affiliated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital,Zhengzhou450008,China
关键词:
β2-微球蛋白;  均匀性;  稳定性;  质量控制
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2018.02.001
文献标志码:
A
摘要:
目的 制备β2-微球蛋白(β2-MG)质控血清并对其进行质量评价。方法 收集病人混合血清样本制备β2-MG质控物,并依据《能力验证样品均匀性和稳定性评价指南》和ISO Guide 35标准对其均匀性及稳定性进行评价。结果 均匀性检验结果显示制备的2个浓度水平质控物样品内和样品间均匀性差异无统计学意义(F=0.699,2.091,均P>0.05)。在室温条件下保存至少稳定5天(t=-1.76,-2.64,均P>0.05); 4℃储存条件下至少稳定28天(t=-1.86,-2.44,均P>0.05); -20℃储存条件下至少稳定4个月(t=0.26,-2.68,均P>0.05); -80℃储存条件下至少稳定1年(t=-0.96,0.01,均P>0.05)。结论 自制的β2-微球蛋白质控血清制备方便,其均匀性、稳定性符合标准要求。
Abstract:
Abstract:Objective To prepare quality control material of β2-microglobulin(β2-MG),then evaluate the quality of it.Methods The quality control material of β2-MG was prepared withpooled serum from patients.Then according to Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing and ISO Guide 35,thehomogeneity and stability of it was evaluated.Results According to the result of homogeneity test,there was no statistically significant difference between within-groups and between-groups(F=0.699,2.091,all P>0.05)for 2 levels of quality control material.What was more,the stability test showed that it could stabilize for at least 5 days at 25℃(t=-1.76,-2.64,all P>0.05),28 days at 4℃(t=-1.86,-2.44,allP>0.05),4 months at -20℃(t=0.26,-2.68,all P>0.05),and1 year at -80℃(t=-0.96,0.01,all P>0.05).ConclusionQuality control material of β2-MG has simple preparation.The homogeneity and stability of it meets the standard requirements.

参考文献/References:

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备注/Memo

备注/Memo:
作者简介:郝庆钦(1988-),男,硕士,检验医师,研究方向:重大疾病早期诊断和预后评估分级管理,E-mail:hqq847702650@sina.cn。 通讯作者:钱惠忠,男,主任技师,研究方向:临床输血检验,E-mail:gap369@126.com。
更新日期/Last Update: 2018-04-16