摘要
目的:验证某国产果糖胺测定试剂盒(NBT法)在西门子ADVIA1800全自动生化分析仪上的性能指标是否满足相关法规和试剂说明书要求。方法:此次实验参考WS/T420-2013和CLSI EP文件制定性能验证方案,依次对最低检测限(空白限)、精密度(重复性精密度和期间精密度)、线性范围、正确度(相对偏差、回收试验)、参考区间和干扰试验进行验证。结果:最低检测限为0.011 3,批内精密度为0.65%、1.62%,批间精密度为6.7%、6.8%,线性范围为0~8.4mmol/L(R=0.998 7),正确度相对偏差为-2.4%、1.11%、-0.5%,回收率为99.60%和98.27%,参考区间验证结果显示所用样本均在参考值范围之内。结论:验证结果均满足相关法规和试剂说明书要求,验证结论为合格。
Objective： This study is mainly to verify the performance index of Domestic fructosamine testing kits on Siemens ADVIA1800 automatic biochemical analyzer. And find the result whether meet the requirements of relevant laws and regulations and the reagent instructiork Methods： The test plan reference WS/T420-2013 and CLSI EP file. This experiment mainly verifies the minimum detection limit, precision（repeatability precision and within-run precision）, linear range, accuracy （including relative deviation and recovery test） and reference range. Results： The minimum detec- tion limit is 0. 011 3, repeatability precision are 0. 650/00 and 1. 62%, within-run precision are 6. 7% and 6. 8%, linear range is 0-8. 4mmol/L（R= 0. 998 7）, relative deviation of right degree are -2.4 % and 1.11% and -0.5%, the rate of recovery 99. 60% and 98. 27%, there is no case exceeds reference range in reference range verification. Conclusion： All of validation results meet the requirement of related laws and regulations and the reagent instruction. The test conclusion is qualified.
出处
《医学理论与实践》
2017年第21期3144-3146,共3页
The Journal of Medical Theory and Practice
关键词
果糖胺检测试剂
NBT
法
性能验证
Fructosamine testing reagent, NBT method, Performance verification
