[1]崔皓园a,李臣宾b,周文宾b,等.血管性血友病因子抗原检测参考物质的研制与评价[J].现代检验医学杂志,2015,30(03):6-12.[doi:10.3969/j.issn.1671-7414.2015.03.003]
　CUI Hao-yuana,LI Chen-binb,ZHOU Wen-binb,et al.Preparation and Evaluation of the Reference Materials for Plasma von Willebrand Factor Antigen Testing[J].Journal of Modern Laboratory Medicine,2015,30(03):6-12.[doi:10.3969/j.issn.1671-7414.2015.03.003]
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血管性血友病因子抗原检测参考物质的研制与评价()
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《现代检验医学杂志》[ISSN:/CN:]

卷:
第30卷
期数:
2015年03期
页码:
6-12
栏目:
论著
出版日期:
2015-06-10

文章信息/Info

Title:
Preparation and Evaluation of the Reference Materials for Plasma von Willebrand Factor Antigen Testing
文章编号:
1671-7414(2015)03-008-05
作者:
崔皓园a; 李臣宾b; 周文宾b; 高 倩a; 彭明婷a
a.北京协和医学院研究生院,卫生部北京医院,卫生部临床检验中心;
b.卫生部北京医院,卫生部临床检验中心,北京 100730
Author(s):
CUI Hao-yuana; LI Chen-binb; ZHOU Wen-binb; GAO Qiana; PENG Ming-tinga(a.
a.Graduate School of Peking Union Medical College,Beijing Hospital,National Center for Clinical Laboratories;
b.Beijing Hospital,National Center for Clinical Laboratories,Beijing 100730,China
关键词:
血管性血友病因子;  参考物质;  均匀性;  稳定性;  互通性;  定值
分类号:
R446
DOI:
10.3969/j.issn.1671-7414.2015.03.003
文献标志码:
A
摘要:
目的 利用新鲜冰冻血浆制备血管性血友病因子(von willebrand factor,vWF)抗原检测参考物质并进行评价。方法 采用低温离心法制备5个浓度水平的参考物质。按照ISO Guide35及CNAS-GL03的要求,评价参考物质的均匀性和稳定性; 依据行业标准WS/T 356-2011对参考物质在STAGO和IL检测系统的互通性进行评价; 依据ISO Guide 35的要求以NIBSC凝血标准品(SSCLOT4)为溯源标准采用6家实验室联合为参考物质定值。结果 参考物质均匀性良好,单因素方差分析F值范围0.317～0.844,差异无统计学意义(P＞0.05),瓶间均匀性不确定度ubb为1.01%～2.06%。参考物质浓度在24周内无明显趋势性变化(P＞0.05),长期稳定性不确定度ults为0.79%～1.20%。参考物质在STAGO及IL两种检测系统间互通性良好。各批号定值结果为12.2%～138.9%,定值引入不确定度uchar为0.06%～0.09%。参考物质合成标准不确定度uc为0.03%～0.16%,扩展不确定度U(k=2)为2.2%～6.7%。结论 自制参考物质的均匀性及稳定性符合要求,在STAGO及IL两系统方法间互通性良好,定值结果准确可靠。
Abstract:
Objective To prepare and evaluate the referencematerials for plasma von Willebrand Factor antigen testing with fresh frozen plasma.Methods The candidates were prepared by low temperature centrifugation in 5 different concentration levels.The homogeneity and stability of the preparation was evaluated according to the ISO Guide35 and CNAS-GL03.The comparability between STAGO and IL system was evaluated according to the WS/T 356-2011.Then the preparations were characterized by six laboratories with the Secondary Coagulation Standard established by NIBSC(SSCLOT4).Results Homogeneity evaluation of the preparation showed that there was no statistically significant difference between the groups(P＞0.05),the F values of factor analysis of variance were 0.317～0.844,the uncertainty range was 1.01%～2.06%.A linear regression based on stability evaluation indicated that the linear trend(within 24 weeks)was insignificant(P＞0.05).The uncertainty range of long-term(within 24 weeks)stability was 0.79%～1.20%.The results of the preparations on STAGO and IL system were comparable.The certificated values of the candidates were range from 12.2% to 138.9% withuncertainties were 0.06%～0.09%,respectively.The range of combined standarduncertainty was 0.03%～0.16% while the expanded uncertainty was 2.2%～6.7%.Conclusion The reference materials for von Willebrand Factor antigen testing were stable and homogenous with comparability between STAGOand IL.The method of characterization was accurate and reliable.

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备注/Memo

备注/Memo:
基金项目:国家科技基础性工作专项基金资助课题(2013FY113800)。
作者简介:崔皓园(1989-),女,在读硕士研究生,E-mail:18810828536@163.com。
通讯作者:彭明婷,研究员,主要从事临床血液体液学检验质量控制和标准化研究,E-mail:mtpeng@nccl.org.cn。
更新日期/Last Update: 2015-06-10