GLP体系下生化分析仪的3Q验证过程及要点

Procedures and main points of 3Q validation for biochemical analyzers under the GLP system

目的以日立7100型全自动生化仪为例,探讨良好实验室规范(GLP)管理体系下生化分析仪的3Q验证过程及要点。方法根据美国临床和实验室标准研究所(CLSI)的评价标准,选择血清丙氨酸转氨酶(ALT)、天门冬氨酸转氨酶(AST)、碱性磷酸酶(ALP)、γ-谷氨酰基转肽酶(GGT)、总蛋白(TP)、白蛋白(Alb)、总胆红素(TB)、总胆固醇(CHOL)、甘油三酯(TG)、血糖(Glu)、肌酸激酶(CK)、肌酐(Cre)、尿素(Urea)等13项生化检验指标,对仪器的精密度、准确度、线性、携带污染率以及仪器对比实验进行性能验证。结果所测13项指标的批内精密度CV值≤3%,均小于美国临床和实验室修正法规1988(CLIA'88)最大总误差的1/4;批间CV值均小于CLIA'88最大总误差的1/3;在准确度方面,与靶值的相对偏差,除肌酐为8%外,其余12项均在±5%以内,且符合CLIA'88的要求;13项线性实验相关系数r>0.99,携带污染率<2.5%;对比实验结果显示,7100型生化仪与RA1000型生化仪各项的相关系数r>0.975,有较好的相关性。结论经GLP体系下的3Q验证,该型全自动生化分析仪各方面性能良好,可以用于临床检验实验室的检测工作。

Objective To explore the procedures and main points of the installation,operation and performance qualifi- cations （3Q） validation for biochemical analyzers under the Good Laboratory Practice （GLP） management system based on the Hitachi 7100 automatic biochemical analyzer. Methods According to the evaluation criteria of Clinical and Laboratory Standards Institute （CLSI）,thirteen biochemical items were chosen to evaluate the precision, accuracy; linearity, cross contamination, and machine comparison of the 7100 automatic biochemical analyzer. They were alanine aminotransferase （ ALT）, aspartate aminotransferase （ AST）, alkaline phosphatase （ ALP）, gamma-glutamyl transpeptidase （ GGT）, total protein （ TP）, albumin （Alb）, total bilirubin （ TB）, total cholesterol （ CHOL）, triglycerides （ TG）, glucose （ Glu ）, crea tine kinase（ CK）, creatinine（Cre） ,and urea,respectively. Results The within-run precision（ CV≤3% ） of thirteen items was one-fourth lower than that of Recommendations for Clinical Laboratory Improvement Amendments of 1988 （CLIA＇ 88 ） and the between-run precision was one-third lower than that of CLIA＇ 88. The relative biases for accuracy of the twelve items were in the range of 5% except creatinine （8%）. The linear coefficient r of thirteen items was more than 0.99. The cross contamination rate of the thirteen items was less than 2.5%. The comparison experiment between Hitachi 7100 and RA1000 biochemical analyzers showed the result was good, with a coefficient of more than 0. 975. Conclusion The 3Q validation under the GLP system proves that the Hitachi 7100 automatic biochemical analyzer is good in performance and is appropriate for clinical laboratories.