肾素定量检测试剂盒性能验证  

Performance verification of plasma renin quantitative detection kit

作　　者：吴子安[1] 谭志容[2] 徐宁[1] 曹永坚[1] 刘卓源 

机构地区：[1]广东省中医院芳村医院检验科,广州510370 [2]广州中医药大学研究生院

出　　处：《临床血液学杂志（输血与检验）》2015年第3期493-495,共3页Journal of Clinical Hematology(Blood Transfusion & Laboratory Medicine)

摘　　要：目的:对血浆肾素(RENIN)定量检测试剂盒进行相关的性能验证,判断该试剂盒是否能够满足笔者实验室的日常检验要求。方法:分析肾素定量检测试剂盒的精密度(包括重复性和中间精密度),同时比较分别使用上述试剂盒和肾素活性方法检测患者标本所得结果的一致性情况。结果:肾素定量试剂盒的重复性及中间精密度验证实验中,检测2个水平质控品变异系数分别是2.7%、1.2%和3.1%、3.8%,肾素定量和肾素活性2种方法分别检测51份患者标本,结果一致的有41份,其中阳性5份,阴性36份,只有10份标本是肾素活性方法结果为阳性,肾素定量方法结果为阴性。10份不一致标本与36份一致的阴性标本的肾素定量检测结果之间差异有统计学意义(P<0.05),2种方法的相关性分析显示,y=3.2613x+0.6091,R=0.919。结论:该肾素定量检测试剂盒性能验证有效,可应用于实验室日常检测需要,其结果与以往使用的肾素活性检测方法具有可比性。Objective：To verify the performance of the quantitative detection kit for plasma renin concentration（PRC）in order to know whether the kit is fit for the author＇s laboratory.Method：The precisions includes repeatability and intermediate precision of PRC quantitative detection kit were analyzed,and the accordance of results detected by PRC quantitative detection kit and plasma renin activity（PRA）kit was analyzed.Result：The repeatability and intermediate precisions of the PRC quantitative detection kit in two levels were 2.7%,1.2% and 3.1%、3.8%.Being tested by the two methods,total forty-one specimens were the same results included five positive specimens and thirty-six negative ones.There were significant differences between the results analyzed by the PRC quantitative detection kit of the ten specimens which results were different tested by the two methods and the thirty-six negative specimens.The correlation analysis between the two methods showed y=3.2613x＋ 0.6091,R=0.919.Conclusion：The performance verification of the PRC quantitative detection kit may be effective,which results would be comparative to the PRA kit.

关 键 词：肾素定量 肾素活性 性能验证 

分 类 号：R692[医药卫生—泌尿科学]