患者新鲜混合血清作为临时校准液校正非配套检测系统

Mixed fresh serum of patients as a temporary calibrator for calibrate of non-matchinganalytic system

目的患者新鲜混合血清作为校准液用于非配套检测系统7170A全自动生化分析仪的溯源性分析。方法以拜耳试剂及程序、校准品、质控品、拜耳2400全自动生化分析仪为标准检测系统,用罗氏cfas校准品的标准值直接校准日立7170A/利德曼试剂检测系统;然后以新鲜患者混合血清作为临时校准品,罗氏cfas校准品经标准系统准确度传递后,把罗氏cfas校准品的标示值转换为校正"日立7170A/利德曼试剂"测定系统的实际校正值,再用此值校正日立7170A/利德曼试剂系统,在上述两种检测系统上同时测定40份患者新鲜血清的尿素(UREA)、丙氨酸氨基转移酶(ALT)、肌酸激酶(CK)、糖(Glu)、清蛋白(ALB)、肌酐(Cr)、尿酸(UA)、总胆红素(TBIL)、总胆固醇(TC),并对所得结果进行线性回归分析。结果罗氏cfas校准品的标示值经标准检测系统准确度传递后,直接校正日立7170A/利德曼试剂系统时,各指标的均值与标准系统的均值相对偏倚分别为1.65%、2.61%、3.11%、2.05%、1.30%、3.45%、2.02%、3.90%、2.94%。各指标均值相对偏倚均小于1/2CLIA′88,同时线性回归良好。结论患者新鲜混合血清作为临时校准品,经过标准系统准确度传递后可用于校正非配套检测系统。

Objective Take mixed fresh serum from the patients as a calibration fluid detection system for non-matching 7170A automatic biochemical analyzer in analysing the source. Methods With Bayer reagents and procedures,calibration materials, quality control, and Bayer 2400 automatic biochemical analyzer detection system, the standard value of Hitachi 7170A/Lidemen reagents was detected directly in accordance with the standard of Roche Calibrator cfas ; and then mixed with fresh serum of patients as a temporary calibrator,Roche Calibrator cfas accura- cy by the standard system after the transfer,the Roche Calibrator cfas value was converted to the marked correction ＂Hitachi 7170A/Lidemen reagents＂, Then the accuracy was transmitted to the fresh mixed patient sera from the standard system. The indicative value of the Roche Calibrator cfas was transferred into the actual value in the Hitachi 7170A/Lidemen system. UREA.ALT,CK,Glu,ALB,Cr,UA,TBIL,TC in 40 fresh sera were measured by the two analytic systems mentioned above,and the results of linear regression were analysed. Results After the accuracy delivered by Roche cfas calibrator value of goods marked by the standard system,and when the direct correction of Hitachi 7170A / reagent systems was finished,the mean and standard indicators of the mean relative bias system were 1.65%,2.61%,3.11%,2.05%,1.30%,3.45%,2.02%,3.9% ,and 2.94% respectively; the relative bias were all less than 1/2CLIA＇88. Meanwhile,the linear regressions were good. Conclusion The mixed fresh serum of patients as a temporary calibration goods,after the transimission of the accuracy by the standard system,can be used for correcting non-matched detection system.