非配套检测系统溯源性的建立及其确认  

Establishment and Validation of traceability of Non-matching analytic system

作　　者：刘远程[1] 郭永灿[1] 张帮林[2] 刘欣[1] 邱厚兵 杨小川[2] 

机构地区：[1]四川省泸州医学院附属中医医院,646000 [2]四川省泸州市中医院检验科,646000

出　　处：《国际检验医学杂志》2010年第6期531-532,535,共3页International Journal of Laboratory Medicine

摘　　要：目的探讨实现实验室非配套检验系统的溯源性及其确认的方法。方法以新鲜患者血清为临时校准品,在Roche Modular PI检测系统上定值后校准非配套检测系统,校准验证有效后,在非配套检测系统上对日常校准品进行定值,用新的校准值校准自建检测系统,经校准验证后,按EP9-2A文件进行方法比对,评估非配套检测系统与Roche Modular PI系统检测结果的偏倚是否在可接受范围内。结果非配套Alcyon300检测系统中总蛋白(TP)、白蛋白(Alb)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、尿素(Urea)、肌酐(Cr)、尿酸(UA)、血糖(Glu)、淀粉酶(AMY)及AFT检测系统中钾(K)、钠(Na)、氯(Cl)经过校准和校准验证后,与Roche Modular PI检测系统差异有统计学意义(P<0.05),除Urea、UA、AST、ALT及Glu与目标检测系统在医学决定水平值处偏倚部分接受外,其余项目偏倚均小于CLIA′88允许总误差的二分之一(1/2TEa),临床可以接受。结论校准和校准验证可以实现非配套系统量值溯源性和可比性的有效途径。Objective To explore a method to achieve the traceability and validation of non-matching testing system.Methods The fresh serum of patients was adopted as temporary calibrator and assayed in Roche modular PI testing system（objective testing system）before it was applied tO calibrate in non-matching testing system.After calibration verified successfully,the daily calibrator（c.f.a.s）was determined by non-matching testing system and attainted a new value respectively.Then this new value of calibrator（c.f.a.s）was used to calibrate the non-matching system again.After verified effectively,the bias between Roche modular PI testing system and non-matching system was evaluated by comparative test with EP9-A 2 files,and evaluated that the bias was acceptable or not.Results After calibrated and verified effectively respectively,there was significant correlation between Alcyon300 testing system（TP,Alb,AST,ALT,AMY,Ure,Cr,Ua and Glu）and AFT testing system（K,Na and Cl）.Except that the bias of items（Ure,Ua,AST,ALT and Glu）was partly acceptable at the medical decision level,all the others were lower than half of CLIA 88 allowable total errors.Conclusion The traceability and comparability of non-matching testing system can be achieved by calibration and verification.

关 键 词：生物化学 电解质 实验室技术和方法评价研究 

分 类 号：R197.39[医药卫生—卫生事业管理]