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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 take the Hitachi 7100 automatic biochemical analyzer as an example to discuss the 3Q verification process and key points of the biochemical analyzer under the GLP management system. Methods According to the criteria of CLSI, serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), γ-glutamyl trans (GGT), total protein (TP), albumin (Alb), total bilirubin (TB), total cholesterol (CHOL), triglyceride (TG), blood glucose (Glu), creatine kinase (CK) Creatinine (Cre), urea (Urea) and other 13 biochemical test indicators, the instrument’s precision, accuracy, linearity, carry contamination rate and instrument performance comparison of the experimental verification. Results The intra-assay CV values of all the 13 indexes were less than or equal to 3%, which were all less than 1/4 of the maximum total error of CLIA88 in the United States. The inter-assay CV values were less than the maximum of CLIA’88 The total error of 1/3; in terms of accuracy, the relative deviation from the target, in addition to 8% of creatinine, the remaining 12 were within ± 5%, and meet CLIA’88 requirements; 13 linear correlation coefficient r> 0.99, carrying pollution rate <2.5%. The experimental results show that the correlation coefficient between the 7100 biochemical analyzer and the RA1000 biochemical analyzer is> 0.975, which shows a good correlation. Conclusion The GLP system under the 3Q verification, this type of automatic biochemical analyzer performance in all aspects of good, can be used for clinical laboratory testing.