2种试剂对实验动物凝血酶原时间检测结果的比对分析  

Comparison analysis of two reagents for laboratory animal prothrombin time testing

作　　者：潘东升[1] 汪巨峰[1] 李波[1] 

机构地区：[1]中国食品药品检定研究院国家药物安全评价监测中心,北京100176

出　　处：《药物分析杂志》2016年第9期1618-1622,共5页Chinese Journal of Pharmaceutical Analysis

基　　金：国家"重大新药创制"科技重大专项(2012ZX09302-001)

摘　　要：目的:比对分析仪器配套的2种试剂对不同实验动物凝血酶原时间测定值,评价检测结果是否存在差异。方法:用Thromborel-S(TS)与Thromboplastin.C.Plus(CPLUS)2种凝血酶原试剂分别对实验动物标本进行检测,然后对检测结果进行配对t检验、相关性分析及信度检验。结果:不同实验动物凝血酶原时间,CPLUS试剂检测结果高于TS试剂,且两组数据存在显著性差异。结论:TS试剂与CPLUS试剂对实验动物凝血酶原时间的检测结果存在显著差异,不存在一致性,在同一个毒性研究中不可以交叉使用这2种试剂。Objective：To compare and analyze the prothrombin time between two reagents matched with instrument on laboratory animals,and to explore the differences between these two reagents.Methods：Specimens from laboratory animals were tested using Thromborel-S（TS）and Thromboplastin. C. Plus（CPLUS）reagents,data were analyzed by paired t test,simple correlation analysis and intra- class correlation analysis.Results：Compared to TS,prothrombin time result was higher when a specimen was tested with CPLUS.There were statistically significant differences between the two groups of data obtained from two reagents separately.Conclusions：Different reagents can result in statistically significant differences in the prothrombin time with poor consistency,so these two kinds of reagents cannot be used cross on individual toxicity study.

关 键 词：药物毒性试验 凝血系统筛选实验 凝血酶原时间 Thromborel-S Thromboplastin.C.Plus 信度检验 

分 类 号：R917[医药卫生—药物分析学]