血凝质控物的研制

Study on blood coagulation quality control material

目的 研制血凝质控物 ,以保证血凝质控工作的开展。方法 血浆中加入稳定剂 ,经冷冻干燥制备血凝质控物。置于 4～ 8℃、室温和 37℃ ,与德国DADEBEHRING质控物一同测定 ,每周测定 1次 ,观察其稳定性。随机抽取一定数量样品评价其均匀性。用不同仪器、不同试剂测定该血凝质控物 ,以观察其适应性。结果 4～ 8℃、室温和 37℃条件下 ,每周检测 1次 (一式二份 ) ,经近 8个月观察 ,4～ 8℃ ,P >0 .0 5 ;室温 3个月 ,P >0 .0 5 ;37℃ 3周 ,P >0 .0 5。瓶间均匀性结果经方差分析 ,凝血酶原时间 (PT)F =0 .4 2 3,F <F(0 .0 5 ) ,P >0 .5 19;活化部分凝血酶原时间 (APTT)F =0 .834,F <F(0 .0 5 ) ,P >0 .372 ;纤维蛋白原 (FIB)F =0 .6 85 ,F <F(0 .0 5 ) ,P >0 .4 18。血凝质控物和国外同类产品以及新鲜血浆用不同仪器和不同试剂测定的差异相近 ,经t检验差异无显著性。结论 该血凝质控物稳定性、均匀性、适应性好 。

Objective To manufacture blood coagulation quality control material in order to develop quality control for blood coagulation tests.Methods Stabilizer was added in plasma and lyophilized. The blood coagulation quality control material and Dade Behring quality control material made in Germany were stored in 4-8℃, 25℃ and 37℃,and determined one time one week. The manufactured blood coagulation quality control material was sampled randomly to evaluate and analyzed with various instruments and kits.Results The results were not different significantly(P>0.05) when the two quality control materials were stored under 4-8℃ for eight months, 25℃for three months and 37℃ for three weeks. Bottle-to-bottle variation of PT, APTT and FIB statistical analysis(ANOVA) were F 0.423(P>0.519), F 0.834(P>0.0.372), F 0.68(P>0.418), respectively. The differences of the two quality control materials analyzed with various instruments and kits were not significant (P> 0.05).Conclusion The stability and bottle-to-bottle variation of manufactured blood coagulation quality control material are satisfactory.