目的对速率法测定血浆谷氨酸脱氢酶(GLDH)活性进行方法学评价,以确定其分析性能是否符合临床实验室应用的要求。方法由ADVIA 2400全自动化分析仪和武汉生之源生物科技股份有限公司的GLDH检测试剂组成检测系统,参照CLSI提供的临床检验方法学评价方案EP5-A2、EP 6-A、EP7-A2、EP15-A分别对该检测系统的精密度、线性范围、干扰、正确度等性能进行评价。结果该检测系统的高、低2个GLDH水平的批内CV分别为3.09%和4.88%,总精密度CV分别为3.83%和5.74%;浓度在2.9~155.4U/L的范围内样本,测定结果为线性;干扰物血红蛋白(Hb)=2g/L;三酰甘油(TG)=5.6mmol/L;总胆红素(TB)=342μmol/L;维生素C(Vc)=6g/L时,干扰相对偏差从-1.81%到4.82%不等,对检测结果无明显干扰;正确度验证时偏差≤10.59%。开瓶后30d内试剂吸光度值无明显变化,试剂稳定性良好。结论该GLDH试剂盒的精密度、分析范围、分析特异性、正确度、试剂稳定性等重要指标与试剂盒声明性能指标一致,可以满足临床检测需要。 OBJECTIVE To evaluate the methodological determination of plasma glutamate dehydrogenase (GLDH) activity by rate method in order to determine whether its analytical performance meets the requirements of clinical laboratory applications. Methods The detection system consisted of ADVIA 2400 automatic analyzer and GLDH reagent from Wuhan Bio-tech Co., Ltd. According to CLSI’s clinical testing methodological evaluation program EP5-A2, EP 6-A, EP7-A2 and EP15 -A, respectively, the detection system of precision, linear range, interference, accuracy and other performance evaluation. Results The intra-assay CV of the two high and low GLDH levels were 3.09% and 4.88%, respectively. The total precision CV was 3.83% and 5.74%, respectively. The concentration ranged from 2.9 to 155.4U / L, The results were linear; the interferences of hemoglobin (Hb) = 2g / L; triglyceride (TG) = 5.6mmol / L; total bilirubin (TB) = 342μmol / L; vitamin C (Vc) = 6g / The relative deviation of the interference ranged from -1.81% to 4.82%, with no significant interference with the test results. The deviation of accuracy verification was ≤10.59%. Within 30 days after opening the reagent absorbance value no significant change, reagent stability is good. Conclusion The GLDH kit’s precision, analytical range, analytical specificity, accuracy, stability of reagents and other important indicators consistent with the statement kit performance index, to meet the needs of clinical testing.