中文摘要：

目的对血浆凝血因子Ⅷ（FN）和凝血因子Ⅸ（FIX）活性检测标准物质进行评价和定值。方法按照《标准样品定值的一般原则和统计方法》、《能力验证样品均匀性和稳定性评价指南》和《一级标准物质技术规范》的要求，对3个批号（F01～F03）不同浓度水平的FⅧ和FIX活性检测标准物质进行均匀性和稳定性评价，并以英国国家生物制品检定研究所凝血标准品为溯源标准，选择8家实验室采用一期法对标准物质联合定值。结果FⅧ各批号标准物质均匀性的变异系数（CV）分别为3．9％、3．3％和3．4％，FIX各批号标准物质均匀性CV分别为3．7％，3．0％和1．8％，均匀性评价单因素方差分析结果均P〉0．05，表明标准物质均匀性良好；FⅧ和FIX活性瓶间均匀性不确定度（u。。）分别为0．5％-2．9％和0．1％-3．9％。将标准物质置于一80℃保存条件下，在评价期限内（9个月）FN和FIX活性检测结果无趋势性变化，表明标准物质稳定性良好；其长期稳定性不确定度（uchar）分别为0．5％～5．1％和1．3％～4．4％。定值过程不确定度（uchar）分别为0．9％-2．4％和1．1％～2．4％。合成并扩展不确定度后（扩展因子k=2），3个批号标准物质FⅧ活性定值结果分别为（85±13）％、（36．0±3．4）％和（20．5±2．3）％，FIX活性定值结果分别为（102±13）％、（47．8±6．9）％和（29．3±3．8）％。结论FⅧ和FⅨ活性检测标准物质的均匀性、稳定性良好，定值结果准确可靠。

英文摘要：

Objective To evaluate and characterize the certified reference materials for coagulation factor Ⅷ（FⅧ） and factor IX （FIX） activity testing. Methods The homogeneity and stability of three lots of certified reference materials （F01 -F03 ） with different factor concentrations were evaluated according to guidelines ＂Reference materials-general and statistical principles for certification＂, ＂Guidance on evaluating the homogeneity and stability of samples used for proficiency testing＂ and ＂ Technical Norm of Primary Reference Material＂. The certified reference materials were characterized by eight laboratories using one- stage method, which were calibrated by the coagulation standard provided by the National Institute for Biological Standards and Control （NIBSC） in UK. Results The Coefficient of Variation （CV） of homogeneity test of FVIU activity of three lots of certified reference materials were 3.9% , 3.3% and 3.4% , respectively. While that of FIX activity were 3.7% , 3.0% and 1.8% , respectively. The results of one-way ANOVA showed that all certified reference materials had good homogeneity （ P 〉 0.05 ） , and the between- bottle homogeneity uncertainties （Ubb） of F Ⅷ and F Ⅸ activity were 0. 5% -2. 9% and 0. 1% -3.9% , respectively. All certified reference materials stored in -80 ℃ remained stable in 9 months by trend analysis, and the long-term stability uncertainties（ uhs ） of FⅧ and FⅨactivity were 0. 5% -5.1% and 1.3% - 4.4% , respectively. The characterization uncertainties （ Uchar ） of FⅧ and FⅨ activity testing were 0. 9% -2. 4% and 1.1% -2.4%, respectively. The combined uncertainties and extended uncertainties （ coverage factor k = 2） were calculated. The assigned values of each lot of certified reference materials for FⅧ activity were （85 ±13）%, （36.0 ±3.4）% and （20.5 ±2.3）%, and that were （102±13）%, （47.8 ± 6. 9） % and （29.3 ± 3.8） % for FIX activity, respectively. Conclusions The certified reference m