CAJ | 학술논문

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％～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％～10.5％。 vWF：Ag 批内不精密度为2.2％～3.1％，批间不精密度为2.1％～4.1％。12个项目携带污染率为0～2.63％，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0.982～0.988，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。
목적：대혈전여지혈특수항목적림상검측진행전면성능평개，이기위림상제공가고적검측결과。방법안조미국림상실험실표준화협회（ Clinical and Laboratory Standards Institute， CLSI） EP5-A2、 EP9-A2문건급《위생부림상혈액학검험상규항목분석질량요구 WS/T 406-2012문건》표준，대본실험실 ACL TOP 700전자동응혈분석의측정응혈인자（FⅡ、 FⅤ、 FⅦ、 FⅧ、 FⅨ、 FⅩ、 FⅪ、 FⅫ）、역전증사사삼항（단백S、단백C급항응혈매-Ⅲ）화혈관성혈우병인자항원（ von Willebrand factor antigen， vWF：Ag）공12개항목적준학도、불정밀도、휴대오염솔、선성、방법학비대급삼고범위진행전면성능평고。결과미국병이학가협회제공적12개항목질평물검측결과여파치상비，제단백C저치외편차균소우15％。8개응혈인자비내불정밀도위1.7％～4.4％，균소우4.5％；비간불정밀도위2.2％～7.5％，균불대우7.5％。역전증사사삼항적비내불정밀도위1.0％～7.0％；비간불정밀도위1.5％～10.5％。 vWF：Ag 비내불정밀도위2.2％～3.1％，비간불정밀도위2.1％～4.1％。12개항목휴대오염솔위0～2.63％，균소우3％。선성험증실험결과현시단백S、단백C、항응혈매-Ⅲ급vWF：Ag상관계수위0.982～0.988，균≥0.975。 ACL TOP 700여삼비검측계통진행비교，12개항목검측결과적상관계수균≥0.975，일치성교호。엄상제공적삼고범위균괄용우본실험실。결론 ACL TOP 700전자동응혈분석의대혈전여지혈특수항목검측적준학도、불정밀도、휴대오염솔、현행선성범위급삼고범위험증등성능평개량호，괄용우림상표본검측。
Objective To conduct a comprehensive performance evaluation of fully automated coagulation analyzer in testing coagulation factors , protein S ( PS) , protein C ( PC) , anti-thrombin Ⅲ( AT-Ⅲ) , and von Willebrand factor antigen (vWF:Ag).Methods According to the Clinical and Laboratory Standards Institute (CLSI) EP5-A2, EP9-A2, and WS/T 406-2012 specifications, coagulation factors (FⅡ, FⅤ, FⅦ, FⅧ, FⅨ, FⅩ, FⅪ, and FⅫ) , PS, PC, AT-Ⅲ, and vWF:Ag were detected in the apparatus to evaluate the accu-racy , within-run and between-run imprecisions , linear range , carryover rate , method comparisons , and reference range of the 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 biases of the 12 College of American Pa-thologists ( CAP) controls compared with the target value were all less than 15%, excepting the low value of PC . The within-run imprecisions of 8 coagulation factors were 1.7%-4.4%, and the between-run imprecisions were 2.2%-7.5%.The within-run imprecisions of 3 thrombophilia screen tests and vWF:Ag were 1.0%-7.0%and 2.2%-3.1%, and he between-run imprecisions were 1.5%-10.5% and 2.1%-4.1%, respectively . The carryover rates of the 12 items ranged from 0 to 2.63%.Results of liner verification test showed the correla-tion coefficients of PS , PC, AT-Ⅲ, and vWF:Ag were 0.982-0.988 .Results of method comprisons showed the correlation coefficients of ACL TOP 700 and other coagulation analyzer were more than 0.975 , and the recommen-ded reference ranges of all the 12 items were appropriate for our laboratory .Conclusions ACL TOP 700 coagu-lation analyzer has a good performance in accuracy , imprecision , carryover rate , linear range , and method com-parison .It is suitable for detection of clinical specimens .