CAJ | 학술논문

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。
목적：이용신선빙동혈장제비혈관성혈우병인자（von willebrand factor，vWF）항원검측삼고물질병진행평개。방법채용저온리심법제비5개농도수평적삼고물질。안조 ISO Guide35급 CNAS-GL03적요구，평개삼고물질적균균성화은정성；의거행업표준 WS／T 356-2011대삼고물질재 STAGO 화 IL 검측계통적호통성진행평개；의거 ISO Guide 35적요구이 NIBSC 응혈표준품（SSCLOT4）위소원표준채용6가실험실연합위삼고물질정치。결과삼고물질균균성량호，단인소방차분석 F 치범위0.317～0.844，차이무통계학의의（P ＞0.05），병간균균성불학정도 ubb 위1.01％～2.06％。삼고물질농도재24주내무명현추세성변화（P ＞0.05），장기은정성불학정도 ults 위0.79％～1.20％。삼고물질재 STAGO 급 IL량충검측계통간호통성량호。각비호정치결과위12.2％～138.9％，정치인입불학정도 uchar 위0.06％～0.09％。삼고물질합성표준불학정도 uc 위0.03％～0.16％，확전불학정도 U（k＝2）위2.2％～6.7％。결론자제삼고물질적균균성급은정성부합요구，재 STAGO 급 IL 량계통방법간호통성량호，정치결과준학가고。
Objective To prepare and evaluate the reference materials 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% with uncertainties were 0.06%~0.09%,respectively.The range of combined standard uncertainty 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 STAGO and IL.The method of characterization was accurate and reliable.