临床输血与检验2011，Vol.13Issue(2)：97-102,6.DOI:10.3969/J.issn.1671-2587.2011.02.001
血浆纤维蛋白原检测质控物的研制及评价
The Preparation and Evaluation of the Quality Control Materials for Plasma Fibrinogen Testing
摘要
Abstract
Objective To prepare a set of quality control materials for plasma fibrinogen testing and evaluate the appearance characteristic, the homogeneity and stability of them.Methods The fibrinogen was concentrated from frozen plasma and added to another part of frozen nomal plasma or fibrinogen poor plasma to prepare five lots of quality control materials in different fibrinogen levels.Then the preparations were dispensed into small glass bottles, frozen and lyophilized.The quality indicator for monitoring the prepared process, containing appearance characteristics, the rehydration quality and residual water were evaluated according to the protocol of control of lyophilized biological products.The homogeneity and stability of preparations was evaluated according to the CNAS-GL03 Guidance on Evaluating the Homogeneity and Stability of Samples Used for Proficiency Testing and the ISO Guide35 Reference Material-general and Statistical Principles for Certification.The preparation was also used as an internal quality control material and was compared with the manufacture material.Results All preparations had an acceptable appearance and rehydration quality, which the variable range of residual water was 1.79％～ 2.15％.In the homogeneity evaluation the results showed that there was insignificant difference between the groups (P＞0.05).A linear regression based on the stability test indicated there was no linear trend between the assayed value and time (P＞0.05).The uncertainty range of the homogeneity and longtime stability was (0.009～0.023) g/L and (0.020 ～0.036) g/L.The range of CV between-days of the five preparations was between 2.3％ and 3.6％,which was equivalent to that of manufacture material (3.4 ％).Conclusion The fibrinogen quality control materials prepared by us meet the needs of the homogeneity and longtime stability of the quality control material,and can be used in internal quality control of fibrinogen testing.关键词
纤维蛋白原/质控物/均匀性/稳定性Key words
Fibrinogen/ Quality control material/ Homogeneity/ Stability分类
医药卫生引用本文复制引用
周文宾,彭明婷,李臣宾,苏炳男,陆红,谷小林..血浆纤维蛋白原检测质控物的研制及评价[J].临床输血与检验,2011,13(2):97-102,6.基金项目
本课题受国家高技术研究发展计划(863计划)(No.2006AA020909)资助 （863计划）
