CAJ | 학술논문

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。
목적：응용EP9-A대모국산전백단백재Beckman상적자건검측계통，병진행평개화편차평고。방법：의거미국림상실험실표준화위원회(NCCLS)EP9-A응용북경리덕만전백단백（PA）시제합급기배투교준품、질공품재Beckman DXC800전자동생화분석의적검측계통대40빈환자신선혈청적PA진행검측，병여Beckman공사원장배투적전백단백시제합（PAB）비대，대검측농도진행계통평개화편차분석。결과：북경리덕만전백단백（PA）시제재Beckman DXC800전자동생화분석의상적준학도、비내정밀도、선성균부합요구，량충시제검측결과무현저차이（P>0.05），구유교호적가비성，기상관계수（r2）>0.99。결론：자건검측계통혈청PA검측결과여Beckman가소원적삼고검측계통상비，가피림상접수。
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 DXC800 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.