应用国产前白蛋白在Beckman上自建检测系统及其评价

Evaluation of self-established assay system in Beckman DXC800 chemistry analyzer measured by prealbumin reagent kits

目的:应用EP9-A对某国产前白蛋白在Beckman上的自建检测系统,并进行评价和偏差评估。方法:依据美国临床实验室标准化委员会(NCCLS)EP9-A应用北京利德曼前白蛋白(PA)试剂盒及其配套校准品、质控品在Beckman DXC800全自动生化分析仪的检测系统对40份患者新鲜血清的PA进行检测,并与Beckman公司原装配套的前白蛋白试剂盒(PAB)比对,对检测浓度进行系统评价和偏差分析。结果:北京利德曼前白蛋白(PA)试剂在Beckman DXC800全自动生化分析仪上的准确度、批内精密度、线性均符合要求,两种试剂检测结果无显著差异(P>0.05),具有较好的可比性,其相关系数(r2)>0.99。结论:自建检测系统血清PA检测结果与Beckman可溯源的参考检测系统相比,可被临床接受。

Objective：To evaluation the comparability and clinical acceptability of national prealbumin reagent kits measured by the self-established assay system in Beckman DXC800 chemistry analyzer.Methods：The levels of prealbumin in 40 patients＇ fresh serum, Calibrators and Controls were analyzed by self-established and Beckman ref- erence assay system. To compared with each other, the bias were estimated according to National Committee for Clini- cal Laboratory Standards （NCCLS） document EP9A2 files. Results：The trueness, inter-precision and linear of Beijing Leadman prealbumin reagent kits measured by the self-established assay system in Beckman DXCS00 chemistry an- alyzer were acceptable. There was no statistically significant difference, P 〉0.05. The correlation coefficient （r2） was more than 0.99. Conclusion：The comparability of national prealbumin measured by the self-established assay system in Beckman DXC800 chemistry analyzer compared with Beckman reference assay system was acceptable.