ACL TOP 500全自动凝血分析仪的检测性能评价  

Performance evaluation of the automated coagulation analyzer ACL TOP 500

作　　者：张丽[1] 管晓媛[1] 段兵[1] 黄一玲[1] 田蕾[1] 李一石[1] 

机构地区：[1]中国医学科学院北京协和医学院阜外医院卫生部心血管药物临床研究重点实验室,北京100037

出　　处：《中国卫生检验杂志》2016年第7期965-968,共4页Chinese Journal of Health Laboratory Technology

基　　金：国家十二五"重大新药创制"科技重大专项(2012ZX0-9303-008-001);国家临床重点专科建设项目(卫生部重点实验室项目)

摘　　要：目的对ACL TOP 500全自动凝血分析仪进行检测性能评价,包括精密度、准确度和线性范围,并验证参考区间。方法使用原装配套试剂、校准品和质控品,评价凝血酶原时间(PT)、活化的部分凝血活酶时间(APTT)和纤维蛋白原(FIB)的精密度和准确度,至少20次质控品的检测结果用于评价精密度;20份样本的检测结果与另一台同型号仪器比对用于评价准确度;采用5份样本评价FIB的线性范围;20份健康个体样本用于验证上述3个项目及国际标准化比值(INR)的参考区间。结果所有项目两水平质控品检测结果的变异系数均<3.6%;全部样本各项目与同型号仪器的比对结果的差异在总误差范围内;FIB的线性范围为0.52 g/L^7.74 g/L;拟验证的参考区间可接受。结论 ACL TOP 500全自动凝血分析仪的检测性能良好,能满足临床实验室的要求。Objective The performance of automated coagulation analyzer ACL TOP 500 was evaluated,including precision,accuracy and linearity,and the reference intervals were validated. Methods The precision and accuracy were evaluated by the determination of routine coagulation（ prothrombin time,activated partial thromboplastin time,fibrinogen） with original reagents,calibrator and control material. The precision was evaluated with the detection results of control materials tested for at least 20 times. The detection results of 20 samples were compared with another analyzer ACL TOP 500 to evaluate the accuracy. The FIB linearity range was verified by 5 samples values. The reference intervals of these three parameters and international standard ratio（ INR） were validated by 20 cases of healthy individual samples. Results The coefficients of variation（ CV） was blow3. 6% for the test results of two control materials in all of the parameters. The relative deviation of the test results between all the sample parameters and other different machines was below total error. The linearity range of FIB was among 0. 52 g / L-7. 74 g / L. All the reference intervals to be verified were acceptable. Conclusion The automated coagulation analyzer ACL TOP 500 can meet the needs of clinical laboratories with superior performance.

关 键 词：精密度 准确度 线性 参考区间 

分 类 号：R446.1[医药卫生—诊断学]