2种不同检测系统凝血分析仪在肝病临床的应用评估  

Clinical application of two blood coagulation analyzers for liver disease

作　　者：李妍[1] 王晗[1] 杨宁[1] 耿伟[1] 洪炜[1] 

机构地区：[1]解放军302医院临床检验医学中心、全军感染病临床实验诊断中心,北京100039

出　　处：《医疗卫生装备》2016年第1期81-84,共4页Chinese Medical Equipment Journal

基　　金：院长创新基金项目(YNKT2012031)

摘　　要：目的 :对Beckman Coulter ACL-TOP和Sysmex CA-7000 2种全自动凝血分析仪进行性能评价,并探讨其临床应用价值。方法:对2种全自动凝血分析仪进行精密度、正确度以及生物参考区间评价,并对其抗黄疸干扰能力及超线性检测结果进行分析,判断不同凝血检测系统在肝病检测应用的临床可接受性。结果:ACL-TOP和CA-7000 2种凝血分析仪的精确度、正确度和正常参考范围等性能指标符合判断标准。2种凝血分析仪对总胆红素<190μmol/L的凝血4项检测标本具有抗干扰能力:总胆红素>190μmol/L时影响度>15%;总胆红素在436μmol/L时,凝血酶原时间(PT)检测受到干扰,并随黄疸不断升高,且PT、活化部分凝血活酶时间(APTT)、凝血酶时间(TT)和纤维原蛋白(FIB)结果超出线性范围。临床对ACL-TOP和CA-7000 2种凝血分析仪超线性检测结果的可接受率分别为87%和83%。结论:2种不同检测系统的血凝分析仪均具有良好的性能,并有一定的抗黄疸干扰能力,但超出一定的范围后会对凝血4项的检测结果造成影响。Objective To evaluate the performances and clinical values of Beckman Coulter ACL-TOP and Sysmex CA- 7000 automatic blood coagulation analyzers. Methods The two analyzers were evaluated for precision, accuracy and biological reference interval, and were analyzed for anti-icterus interference ability and superlinear detection result to determine their clinical acceptability for liver disease detection.Results The two analyzers meeting the requirements in precision, accuracy and reference interval gained anti-interference ability for 4 examination items of blood coagulation in case the total bilirubin was less than 190 μmol/L, and had the influence degree more than 15% in case the total bilirubin was more than 190 μmol/L. When the total bilirubin was 436 μmol/L, PT detection encountered interference, PT value increased with the progress of icterus, and the results of PT, APTT, TT and FIB exceeded the linear range. The clinical acceptable rates for the superlinear results by the analyzers were 87% and 83% respectively. Conclosion The two blood coagulation analyzers gains high performances and anti-icterus interference ability, while have the results of 4 examination items of blood coagulation affected in case the icterus goes beyond some range.

关 键 词：凝血分析仪 肝病临床 性能验证试验 抗干扰能力评价 

分 类 号：R446.1[医药卫生—诊断学]