临床生化检验的校准验证质量评价结果分析

Analysis of the results of calibration and verification of quality evaluation of clinical biochemistry inspection

目的通过对参加卫生部临床检验中心2008年全国校准验证室间质量评价结果进行分析,总结在临床生化、电解质定量检查的校准验证中的经验。方法按设备厂家说明进行校准,按照美国临床实验室改进修正案(CLIA′88)的标准,对检测的钙、磷、镁、葡萄糖、尿素、肌酐、总蛋白、清蛋白、三酰甘油等9个项目定量校准验证结果进行回归方程评价和百分差异评价。结果参加定量分析校准验证的9个项目中,1个项目线性评价为线性1,5个项目为线性2,3个项目为非线性;校准验证评价4个项目的结果为差异2,5个项目的评价结果为验证2。查找原因并更换设备光源后重复试验结果3个项目为线性1,6个为线性2,校准验证评价3个项目为验证1,6个项目为验证2。结论原校准验证质量存在不足,产生差异的主要因素是系统误差所致,经改善实验条件,完善校准方法后,校准验证实验结果满意。

Objective By the analysis of the results of calibration and verification of Quality evaluation of clinical biochemistry inspection of NCCI. at 2008 in our laboratory, sum up the experience and lessons of calibration and verification on detecting biochemistry and electrolyte. Methods Measured the value of Ca,P,Mg,Glu,Urea,Cr,TP,Alb and TG according to the instructions supplied by the manufacturer and the standard of CLIA＇88,and evaluated the regression equation and percentage discrepancy of the value. Results There was 1 testing item＇s linear estimation inear 1 ,and 5 testing item＇s linear estimation inear 2 ,and 3 items＇s line ar estimation were nolinear among the 9 items. There were 4 items＇s result of evaluation of calibration and verification were validation 1,and 5 items＇s result of estimation of calibration and verification were validation 2. And there were3 items＇s linear estimation inear 1 ,and 6 items＇s linear estimation inear 2 after change the light source. Conclusion Our laboratory＇s quality of calibration and verification exsits shortcomings,and the main reason of leading to discrepancy maybe the system error, and the result of quality e valuation of calibration and verification is good after improving the condition of test and perfecting the test methods.