Ⅷ C and ⅧR: Ag were measured in 24 mothers of patients with hemophilia A in present studies.The rate of detecting hemophilia A carrier by using these methods was more than 90%.There are 10% mistake rate reported by ...Ⅷ C and ⅧR: Ag were measured in 24 mothers of patients with hemophilia A in present studies.The rate of detecting hemophilia A carrier by using these methods was more than 90%.There are 10% mistake rate reported by other investigatoro in diagnosis of hemophilia A carrier based on the Ⅷ: C and ⅧR: Ag determination. Although these method is less precise than that of gene diagnosis in detecting hemophilia A carrier, the former is much simple and practicable. Conditionally, the gene diaguosis is not currently available in this country.The measurement of Ⅷ: C and ⅧR:Ag is a good screening method with high detecting rate for carrier detection.展开更多
目的对一期凝固法凝血因子Ⅷ活性(FⅧ:C)检测系统进行性能验证。方法依据中国合格评定国家认可委员会(CNAS)-GL037《临床化学定量检验程序性能验证指南》及相关卫生行业标准提供的方案,对ACL TOP 700全自动凝血分析仪及其配套试剂一期...目的对一期凝固法凝血因子Ⅷ活性(FⅧ:C)检测系统进行性能验证。方法依据中国合格评定国家认可委员会(CNAS)-GL037《临床化学定量检验程序性能验证指南》及相关卫生行业标准提供的方案,对ACL TOP 700全自动凝血分析仪及其配套试剂一期凝固法测定FⅧ:C精密度、正确度、准确度、线性范围、可报告范围、定量检出限、医学决定水平不精密度、携带污染率、抗干扰实验及参考范围进行验证。结果批内不精密度变异系数(CV)值为1.8%~4.1%(≤5%),批间不精密度CV值为3.5%~3.9%(≤10%)。正确度:偏倚为-1.3%(在±10%范围内)。准确度:两个浓度室间质评物质偏倚差分别为1.81%和-0.87%(均在±10%范围内)。线性范围:14.6%~142.7%(R^(2)=0.9939)。定量检出限:1%,与厂商声称相符。医学决定水平(1%、3%、5%)不精密度为5.1%~8.6%(≤10%)。稀释验证:在32倍及以下稀释时,R值均在80%~120%之间。可报告范围:1%~428.1%。携带污染率:0(≤10%)。干扰实验结果显示有较强的抗干扰能力。参考范围(50%~150%)验证:20例表观健康人有19例检测结果在参考范围内,验证通过。结论一期凝固法Ⅷ因子活性检测系统精密度、正确度、准确度、线性范围、可报告范围、检出限、医学决定水平不精密度、携带污染率、抗干扰能力、参考范围验证等各项性能指标均满足国际标准化组织(ISO)15189的要求,可用于临床检测。展开更多
目的初步研究具有自主知识产权的重组表达人凝血因子(rFⅧ)在研品种的临床前药代动力学。方法建立并优化生色底物活性检测方法,用于测定血浆样品中FⅧ活性浓度(FⅧ∶C);选择市售进口的同类药物Xyntha为参比药物,对只敲除了FⅧ基因的...目的初步研究具有自主知识产权的重组表达人凝血因子(rFⅧ)在研品种的临床前药代动力学。方法建立并优化生色底物活性检测方法,用于测定血浆样品中FⅧ活性浓度(FⅧ∶C);选择市售进口的同类药物Xyntha为参比药物,对只敲除了FⅧ基因的模型小鼠(HA小鼠)分组(n=18)单次尾静脉注射280 IU·kg-1受试药rhFⅧ或参比药Xyntha,在0、0.083、1、3、6、9、24、36和48 h采集血浆样品(30μL/只,每个时间点6个样品),测定其FⅧ∶C并计算药代动力学参数。结果受试rhFⅧ组和参比药Xyntha组给药后,0.083、1、3、6、9、24、36和48 h的血浆FⅧ∶C(IU·mL-1)分别为3.218±1.511 vs 3.616±1.504、2.089±0.593 vs 2.786±1.157、1.953±0.546 vs1.942±0.807、0.613±0.360 vs 1.025±0.321、0.515±0.370 vs 0.894±0.297、0.187±0.082 vs 0.310±0.108、0.061±0.038 vs 0.115±0.040、0.043±0.042 vs 0.023±0.012(P>0.05);主要药代动力学参数:t1/2(h)分别为8.83 vs9.15,AUC0-t(h·IU·mL-1)分别为19.67 vs 27.70,Vd(mL·kg-1)分别为176.37 vs 132.00,CL(mL·h-1·kg-1)分别为13.85 vs 10.00,MRT0-t(h)分别为8.64 vs 9.62。结论受试rhFⅧ单次HA小鼠尾静脉给药280 IU·kg-1后在小鼠体内的药代动力学过程与市售同类进口药物Xyntha基本一致。展开更多
文摘Ⅷ C and ⅧR: Ag were measured in 24 mothers of patients with hemophilia A in present studies.The rate of detecting hemophilia A carrier by using these methods was more than 90%.There are 10% mistake rate reported by other investigatoro in diagnosis of hemophilia A carrier based on the Ⅷ: C and ⅧR: Ag determination. Although these method is less precise than that of gene diagnosis in detecting hemophilia A carrier, the former is much simple and practicable. Conditionally, the gene diaguosis is not currently available in this country.The measurement of Ⅷ: C and ⅧR:Ag is a good screening method with high detecting rate for carrier detection.
文摘目的对一期凝固法凝血因子Ⅷ活性(FⅧ:C)检测系统进行性能验证。方法依据中国合格评定国家认可委员会(CNAS)-GL037《临床化学定量检验程序性能验证指南》及相关卫生行业标准提供的方案,对ACL TOP 700全自动凝血分析仪及其配套试剂一期凝固法测定FⅧ:C精密度、正确度、准确度、线性范围、可报告范围、定量检出限、医学决定水平不精密度、携带污染率、抗干扰实验及参考范围进行验证。结果批内不精密度变异系数(CV)值为1.8%~4.1%(≤5%),批间不精密度CV值为3.5%~3.9%(≤10%)。正确度:偏倚为-1.3%(在±10%范围内)。准确度:两个浓度室间质评物质偏倚差分别为1.81%和-0.87%(均在±10%范围内)。线性范围:14.6%~142.7%(R^(2)=0.9939)。定量检出限:1%,与厂商声称相符。医学决定水平(1%、3%、5%)不精密度为5.1%~8.6%(≤10%)。稀释验证:在32倍及以下稀释时,R值均在80%~120%之间。可报告范围:1%~428.1%。携带污染率:0(≤10%)。干扰实验结果显示有较强的抗干扰能力。参考范围(50%~150%)验证:20例表观健康人有19例检测结果在参考范围内,验证通过。结论一期凝固法Ⅷ因子活性检测系统精密度、正确度、准确度、线性范围、可报告范围、检出限、医学决定水平不精密度、携带污染率、抗干扰能力、参考范围验证等各项性能指标均满足国际标准化组织(ISO)15189的要求,可用于临床检测。
文摘目的初步研究具有自主知识产权的重组表达人凝血因子(rFⅧ)在研品种的临床前药代动力学。方法建立并优化生色底物活性检测方法,用于测定血浆样品中FⅧ活性浓度(FⅧ∶C);选择市售进口的同类药物Xyntha为参比药物,对只敲除了FⅧ基因的模型小鼠(HA小鼠)分组(n=18)单次尾静脉注射280 IU·kg-1受试药rhFⅧ或参比药Xyntha,在0、0.083、1、3、6、9、24、36和48 h采集血浆样品(30μL/只,每个时间点6个样品),测定其FⅧ∶C并计算药代动力学参数。结果受试rhFⅧ组和参比药Xyntha组给药后,0.083、1、3、6、9、24、36和48 h的血浆FⅧ∶C(IU·mL-1)分别为3.218±1.511 vs 3.616±1.504、2.089±0.593 vs 2.786±1.157、1.953±0.546 vs1.942±0.807、0.613±0.360 vs 1.025±0.321、0.515±0.370 vs 0.894±0.297、0.187±0.082 vs 0.310±0.108、0.061±0.038 vs 0.115±0.040、0.043±0.042 vs 0.023±0.012(P>0.05);主要药代动力学参数:t1/2(h)分别为8.83 vs9.15,AUC0-t(h·IU·mL-1)分别为19.67 vs 27.70,Vd(mL·kg-1)分别为176.37 vs 132.00,CL(mL·h-1·kg-1)分别为13.85 vs 10.00,MRT0-t(h)分别为8.64 vs 9.62。结论受试rhFⅧ单次HA小鼠尾静脉给药280 IU·kg-1后在小鼠体内的药代动力学过程与市售同类进口药物Xyntha基本一致。
