凝血因子、易栓症筛查三项及血管性血友病因子抗原的临床检测性能评价

目的　对血栓与止血特殊项目的临床检测进行全面性能评价,以期为临床提供可靠的检测结果。方法　按照美国临床实验室标准化协会（Clinical and Laboratory Standards Institute,CLSI）EP5-A2、EP9-A2文件及《卫生部临床血液学检验常规项目分析质量要求WS/T 406-2012文件》标准,对本实验室ACL TOP 700全自动凝血分析仪测定凝血因子（FⅡ、FⅤ、FⅦ、FⅧ、FⅨ、FⅩ、FⅪ、FⅫ）、易栓症筛查三项（蛋白S、蛋白C及抗凝血酶-Ⅲ）和血管性血友病因子抗原(von Willebrand factor antigen, vWF:Ag)共12个项目的准确度、不精密度、携带污染率、线性、方法学比对及参考范围进行全面性能评估。结果　美国病理学家协会提供的12个项目质评物检测结果与靶值相比,除蛋白C低值外偏差均小于15%。8个凝血因子批内不精密度为1.7%⁴.4%,均小于4.5%;批间不精密度为2.2%4.4%,均小于4.5%;批间不精密度为2.2%⁷.5%,均不大于7.5%。易栓症筛查三项的批内不精密度为1.0%7.5%,均不大于7.5%。易栓症筛查三项的批内不精密度为1.0%⁷.0%;批间不精密度为1.5%7.0%;批间不精密度为1.5%¹0.5%。vWF:Ag批内不精密度为2.2%10.5%。vWF:Ag批内不精密度为2.2%³.1%,批间不精密度为2.1%3.1%,批间不精密度为2.1%⁴.1%。12个项目携带污染率为04.1%。12个项目携带污染率为0².63%,均小于3%。线性验证实验结果显示蛋白S、蛋白C、抗凝血酶-Ⅲ及vWF:Ag相关系数为0.9822.63%,均小于3%。线性验证实验结果显示蛋白S、蛋白C、抗凝血酶-Ⅲ及vWF:Ag相关系数为0.982⁰.988,均≥0.975。ACL TOP 700与参比检测系统进行比较,12个项目检测结果的相关系数均≥0.975,一致性较好。厂商提供的参考范围均适用于本实验室。结论　ACL TOP 700全自动凝血分析仪对血栓与止血特殊项目检测的准确度、不精密度、携带污染率、现行线性范围及参考范围验证等性能评价良好,适用于临床标本检测。

Clinical detection study of Coagulation Factors,Protein S,Protein C,AT-III and vWF:Ag

Objective To conduct a comprehensive performance evaluation of fully automated coagulation analyzer in testing coagulation factors (FII、FV、FVII、FX、FVIII、FIX、FXI、FXII), Protein S, Protein C, AT-III and vWF:Ag. Methods According to the CLSI EP5-A2, EP9-A2 and WS/T 406-2012 Standardizations, all the 12 projects were detected in the apparatus to evaluate the accuracy, within-run and between-run precision, linear range, carryover rate, method comparison and reference range validation also had been performed in ACL TOP 700 coagulation analyzer. Results The instrument had high accuracy and precision, a good linear range, and low carryover rate (0%0.988,均≥0.975。ACL TOP 700与参比检测系统进行比较,12个项目检测结果的相关系数均≥0.975,一致性较好。厂商提供的参考范围均适用于本实验室。结论　ACL TOP 700全自动凝血分析仪对血栓与止血特殊项目检测的准确度、不精密度、携带污染率、现行线性范围及参考范围验证等性能评价良好,适用于临床标本检测。Objective To conduct a comprehensive performance evaluation of fully automated coagulation analyzer in testing coagulation factors (FII、FV、FVII、FX、FVIII、FIX、FXI、FXII), Protein S, Protein C, AT-III and vWF:Ag. Methods According to the CLSI EP5-A2, EP9-A2 and WS/T 406-2012 Standardizations, all the 12 projects were detected in the apparatus to evaluate the accuracy, within-run and between-run precision, linear range, carryover rate, method comparison and reference range validation also had been performed in ACL TOP 700 coagulation analyzer. Results The instrument had high accuracy and precision, a good linear range, and low carryover rate (0%².63%, <3%).The bias of all the 12 CAP controls compared with the target value were less than 15%. The within-run precision of 8 coagulation factors were 1.72.63%, <3%).The bias of all the 12 CAP controls compared with the target value were less than 15%. The within-run precision of 8 coagulation factors were 1.7⁴.4% between-run precision were 2.24.4% between-run precision were 2.2⁷.4%. The within-run precision of 3 thrombophilia screen tests and vWF:Ag were 1.07.4%. The within-run precision of 3 thrombophilia screen tests and vWF:Ag were 1.0⁷.0% and 2.27.0% and 2.2³.7%, between-run precision were 1.53.7%, between-run precision were 1.5¹0.5% and 2.110.5% and 2.1⁴.1% respectively. The correlation coefficients of ACL TOP 700 and other coagulation analyzer were more than 0.975, and the recommended reference ranges of all the 12 projects were appropriate for our laboratory. Conclusions ACL TOP 700 coagulation analyzer has a good performance in accuracy, precision, carryover rate, linear range, and method comparison , which is suitable for detection of clinical specimens.