摘要
目的:对STAGO全自动血凝分析系统进行性能验证。方法:对STAGO全自动血凝分析仪的精密度、线性范围和携带污染率进行验证。结果:STAGO全自动血凝分析系统PT、APTT、TT和Fib4个项目的精密度验证均合格;Fib在测定范围内都表现出较好的线性关系(斜率0.97～1.03,r≥0.95); APTT携带污染率验证合格。结论:STAGO全自动血凝分析系统的精密度、线性和携带污染率这三个方面基本满足临床生化检测的实验要求。
Objective: To test and verify the performance of sysmex STAGO automatic analysis system of coagulation. Methods: Verification experiments were taken to measure the precision, linear range and carry-over of STAGO automatic analysis system of coagulation. Results: The precision of PT, APTT, TT and Fib were tested qualified; The linear range of Fib were tested qualified(the slope is in the range of 0.97to 1.03, r≥0.95); The carry-over of APTT was tested qualified. Conclusion: The main performance of precision, the linear range, carry-over of STAGO automatic analysis system of coagulation were consistent with the performance claims of clinical biochemical examination.
作者
张俊国
郑秀娥
李晋
ZHANG Jun-guo;ZHENG Xiu-e;LI Jin(Shandong Provincial Hospital,Shandong Ji?nan 250021;Center for Certification and Evaluation, SDFDA ,Shandong Ji?nan 250014;Shandong Provincial Center for Disease Control and Prevention,Shandong Ji?nan 250014)
出处
《中国医疗器械信息》
2018年第23期7-9,共3页
China Medical Device Information
关键词
STAGO
精密度
线性
携带污染
性能验证
STAGO
precision
linear range
carry-over
performance verification
