STAGO四通道血凝仪应用评价及质量控制  

Evaluation of Performance of STAGO 4-channel Coagulation Analyser and Quality Assurance

作　　者：王德友[1] 张海涛[1] 

机构地区：[1]安徽省蚌埠医学院附属医院检验科,233000

出　　处：《中华全科医学》2003年第2期153-154,共2页Chinese Journal of General Practice

摘　　要：目的　评价STAGO四通道半自动血凝仪的性能 ,并进行有关指标的质量控制。方法　对血浆凝血酶原时间 (PT)、活化部分凝血酶原时间 (APTT)、纤维蛋白原 (FIB)精密度测定及血浆凝血酶原时间、纤维蛋白原的线性分析 ;新旧杯及质控与自制质控血浆比较。结果　PT、FIB线性结果显示 (r =0 .9999、r=- 0 .9880 ) ;精密度PT、APTT、FIBCV <1.13% ,质控批间变异系数 (CV)<1.2 2 % ;批间变异系数 ( 1～ 30d)CV <1.2 6 %、水平 11～ 30d与 30～ 6 0d比较无显著性差异P >0 .0 5,自制质控血浆 1～ 30d与 30～6 0d比较显著性差异P <0 .0 0 1;新与旧杯比较无显著性差异P >0 .0 5。结论　STAGO四通道半自动血凝仪具有较先进的磁珠—凝固检测方法 ,使用联机自动方式提高检测精密度及灵敏度 ,但应严格按照仪器使用与操作 ,做好质量控制 。Objective To assess the performance of STAGO 4-channel semi-auto coagulation analyser and assure the quality of examined items. Methods The accuracies of items including prothrombin time(PT), activated partial thromboplastin time (APTT)and fibrinogen(FIB)were measured;PT and FIB were linearly analysed;New and used cups,Controls and self-made controls were compared, respectively.Results Items of PT and FIB were found to show good linearity( r = 0.9999, r =-0.9880);Coefficents of variation (CV) of the accuracies of the items including PT、APTT and FIB were all lower than 1.13%,CV of coagulation control of between-days <1.22%;CV of between-days(1～30d)is lower than 1.26%;Level 1:no significantly diffrence was noted between 1～30d and 30～60d ( P >0.05);Self-made Controls :significantly diffrence is noted between 1～30d and 30～60d (p<0.001);No significantly diffrence was noted between new and used cups ( P >0.05).Conclusions The working principle of STAGO 4-channel semi-auto coagulation analyser is advanced ball-clotting measurement, its accuracy and senstivity can be improved by the automatic mode. Operation regulations should be conducted strictly to assure the quality in testing and the reliability of the results used in clinic.

关 键 词：凝血酶原时间 活化部分凝血酶原时间 纤维蛋白原 质量控制 

分 类 号：R446.11[医药卫生—诊断学]