血浆纤维蛋白原检测质控物的研制及评价

摘要

目的 研制血浆纤维蛋白原测定质控物,对其外观性状、均匀性和稳定性进行评价,并试应用于室内质控.方法 从血浆中提取纤维蛋白原,加入正常血浆或乏纤维蛋白原血浆中,配制成5个批号不同浓度的纤维蛋白原质控物,分装后进行冷冻干燥.参照<中国生物制品检定规程>要求,对制备过程中的质量指标(外观性状、残水量和复溶性)进行评价;参照CNAS-GL03<能力验证样品均匀性和稳定性评价指南>和ISO Guide35<标准物质的定值-通用原则和统计原理>要求,对质控物的均匀性和稳定性进行评价.将质控物试应用于室内质控,并与商品质控物的检测结果进行比较.结果 质控物的外观性状符合要求,残水量分布范围为1.92%～2.15%,复溶性良好;均匀性评价数据表明质控物样品间差异无统计学意义(P＞0.05);稳定性评价数据的回归分析结果表明,质控物的FIB检测结果随贮存时间变化的线性趋势无统计学意义(P＞0.05),质控物的均匀性和长期稳定性不确定度的分布范围分别为(0.009～0.023) g/L和(0.020～0.036) g/L.5个批号自制质控物室内质控检测结果的日间不精密度(CV%)的分布范围为2.3%～3.6%,商品质控物的CV%为3.4%.结论 自制质控物的均匀性和稳定性良好,能够用于纤维蛋白原检测的室内质控.%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.