Sysmex UF-1000i全自动尿液分析仪试剂的研制与应用评价  

Development and evaluation of Sysmex UF-1000i automated urine analyzer reagents

作　　者：吴永国[1] 刘秀[1] 肖静[1] 曾宪威[1] 刘文毅[1] 

机构地区：[1]深圳市宝安区松岗人民医院检验科,广东深圳518105

出　　处：《现代医学》2015年第4期432-435,共4页Modern Medical Journal

基　　金：深圳市宝安区科技计划项目(2013297)

摘　　要：目的:探讨Sysmex UF-1000i全自动尿液分析仪试剂的有效成分和理化性质,研制用于全自动尿液分析的国产化试剂。方法:对UF-1000i全自动尿液分析仪配套试剂的理化性质及有效成分进行检测分析,自行设计试剂配方,通过临床对比试验、重复性试验、稳定性试验考察自配试剂的可行性。结果:成功设计试剂配方,且原装试剂与自配试剂的渗透压、电导率、p H值等理化性质均一致;采用原装试剂及自配试剂对随机选取的100份临床尿液样本测试发现,检测结果间差异无统计学意义(P>0.05);重复性试验显示WBC、RBC、EC、CAST、BACT各项指标的CV值均小于3%;稳定性试验显示,经1年放置自配试剂的稳定性良好。结论:自行设计配制的UF-1000i全自动尿液分析仪试剂检测结果准确,重复性好,可取代原装试剂在临床使用。Objective： To investigate physicochemical properties and the active ingredient of the Sysmex UF- 1000i automated urine analyzer reagents and develope domestic reagent for automated urinalysis. Methods： Physicochemical properties and the active ingredients of UF-1000i automated urine analyzer reagents were detected and analyzed to design reagent formulation, and then the feasibility of the reagents of own configuration was detected by comparative clinical trials, repeatability test, stability test. Results： The reagent formulation was successfully designed. When compared with the self-made with the original reagents, osmotic pressure, conductivity, pH and other physicochemical properties were consistent. For 100 clinical urine samples, there was no significant difference of the testing results between the self-made and the original reagents（ P 〉 0. 05 ）. Repeated test showed that the CV values of WBC, RBC, EC, CAST, BACT indicators were less than 3%, stability tests showed that reagents was stable after one year. Conclusion： The results using the UF7 1000i automated urine analyzer reagents of our own design are accurate, reproducible, which can replace the original reagents and be widely used in clinical practice.

关 键 词：SYSMEX UF-1000i全自动尿液分析仪 试剂研制 重复性试验 稳定性试验 

分 类 号：R446.12[医药卫生—诊断学]