Analytical performance verification of continuous monitoring assay for detecting plasma GLDH activity / 国际检验医学杂志

ABSTRACT

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.