贝克曼库尔特AU680与AU5400全自动生化分析仪性能比对分析

Comparative analysis on performances of Beckman Coulter AU680 and AU 5400 automatic biochemical analyzers

目的 :根据ISO 15189实验室能力认可管理评审要求,对贝克曼库尔特AU680与AU5400全自动生化分析仪进行性能比对试验,评价检测结果的一致性。方法:收集20份临床血清样本,分别采用AU680与AU5400全自动生化分析仪检测白蛋白(ALB)、总蛋白(TP)、直接胆红素(DILB)、总胆红素(TBIL)、谷丙转氨酶(ALT)、谷草转氨酶(AST)、乳酸脱氢酶(LDH)、碱性磷酸酶(ALP)、γ-谷氨酰转移酶(GGT)、尿酸(UA)、尿素氮(UREA)、肌酐(CREA)、淀粉酶(AMY)、肌酸激酶(CK)、葡萄糖(GLU)、钾(K+)、钠(Na+)、氯(Cl-)等18项指标,计算精密度、准确度等性能指标,并以AU5400全自动生化分析仪为基准,比较2个仪器的性能差异。结果 :2台仪器正常及病理水平质控物批内精密度变异系数均<1/4CLIA′88允许误差,批间精密度变异系数均<1/3CLIA′88允许误差,质控品检测结果差异无统计学意义(P<0.05);检测结果间偏倚比较,以偏倚<1/2EQA为判定标准,所有检测项目合格率均>80%,2台仪器检测结果间具有较好的一致性。结论:AU680全自动生化分析仪具有较好的精密度和准确度,与AU5400全自动生化分析仪检测结果一致性良好,可用于门急诊检测使用。

Objective To compare the performances of Beckman Coulter AU680 and AU5400 automatic biochemical analyzers and evaluate the consistency of the results by the two analyzers based on ISO15189 Laboratory Management Review Request. Methods Twenty pieces of clinical serum samples were collected, and then were analyzed with the two analyzers for ALB, TP, DILB, TBIL, ALT, AST, LDH, ALP, GGT, UA, UREA, GREA, AMY, CK, GLU, K＋, Na＋ and CI-, and then the values of the precision and accuracy were calculated. The performances of the two analyzers were compared with AU5400 as the reference. Results The variation coefficients of the within precision of normal and pathological quality control substances were both less than 1/4 CLIA＇ 88 permitted error, and the inter-assay precision variation coefficients were both less than I/3CLIA＇ 88, and there was no significant difference between the detection results of the quality control substances （P〈0.05）. All the items had the qualified rates higher than 80% with the determination criterion being the bias less than 1/2EQA. There was high consistency between the results by the two analyzers. Conclusion Beckman Coulter AU680 automatic biochemical analyzer behaves well in precision and accuracy, and has high consistency with AU5400 analyzer, and thus can be used for outpatient and emergency diagnosis.