Performance verification of enzymological items measurement by Roche Modular automatic biochemical analyzer

Objective To validate the analytic characteristic of alanine aminotransferase(ALT)and aspartate aminotransferase(AST)measurement by Roche Modular automatic biochemical analyzer.Methods The precision,accuracy,linearity,clinical reportable range,interference and biotic reference interval of ALT and AST were validated according to Clinical and Laboratory Standards Institute(CLSI) documents(EP5-A2,EP15-A2,EP6-A2,EP7-A2 and C28-A2) and other experimental procedures.The results were compared with manufacturer′s claims and acceptable quality standards.Results The precisions were in line with the Roche performance standard.The system error(SE%) of five external quality assessment control samples was-3.94%——9.09% and the variance index scores(VIS) were 50.The SE% of internal quality control(IQC)and quality control service(QCS) was-3.70%-5.85%.ALT and AST showed good linearity(r=0.999,P0.05) and linearity range(4-1 332 U/L and 4-1 031 U/L),and the clinical reportable ranges were 0-133 200 U/L and 0-206 200 U/L respectively.As for AST,hemoglobin(Hb)showed positive interference.As Hb ≤ 6.025 g / L,the interference dose-response series showed linear relationship(P0.05).The validation results of biotic reference interval of ALT and AST were in line with our laboratory reference interval.Conclusions The main analytic characteristic of ALT and AST measurement by Roche biochemical autoanalyzers is consistent with acceptable quality standards,and the experimental evaluation project of CLSI shows maneuverability and practicability.