速率法测定血浆谷氨酸脱氢酶活性的分析性能验证

摘要

Objective To evaluate the analytical performance of glutamate dehydrogenase(GLDH) activity detection kit using continuous monitoring assay.Methods GLDH activity was determined by using continuous monitoring assay on ADVIA 2400 automatic biochemistry analyzer.Performance characteristics,including precision,linearity,interference and accuracy,were evaluated respectively according to EP5-A2,EP 6-A,EP7-A2,EP15-A document issued by Clinical and Laboratory Standards Institute(CLSI).Results The coefficient of variation(CV) of within-run and total precision at high concentration(45.0 U/L) were 3.09% and 3.83% respectively,CV of within-run and total precision at low concentration(21.1 U/L) were 4.88% and 5.74% respectively.The linear range was 2.9-155.4 U/L.The interference bias of 2 g/L hemoglobin,342 μmol/L bilirubin,0.3 g/L vitamin C and 5.6 mmol/L triglyceride were less than 4.82%.For the accuracy based tests,the bias was less than 10.59%.Conclusion The analytical performance of the GLDH detection kit could achieve the manufacturer''s performance indication and meet the clinical needs.%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2.9~155.4 U/L的范围内样本,测定结果为线性;干扰物血红蛋白(Hb)=2 g/L;三酰甘油(TG)=5.6 mmol/L;总胆红素(TB)=342 μmol/L;维生素C(Vc)=6 g/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30 d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.