Assessment of the performance of Roche Modular DP automatic biochemical analyzer

Objective To assess the performance of Roche Modular DP automatic biochemical analyzer by detecting its precision and accuracy.Methods According to EP15-A2 from Clinical and Laboratory Standards Institute(CLSI),23 parameters were measured [alanine aminotransferase(ALT),aspartate aminotransferase(AST),alkaline phosphatase(ALP),gamma-glutamyltransferase(GGT),lactate dehydrogenase(LDH),total protein(TP),albumin(Alb),total bilirubin(TBil),direct bilirubin(DBil),serum glucose(Glu),urea,creatinine(Cr),uric acid(UA),triglycerides(TG),total cholesterol(TC),potassium(K),sodium(Na),chloride(Cl),calcium(Ca),magnesium(Mg),inorganic phosphorus(Phos),creatine kinase(CK),alpha-amylase(Amy)] by Modular DP analyzer and the original reagents.The precisions and accuracies of all parameters were verified.Results In the 2 levels of tested parameters,the standard deviation of repeatability(sr) was ≤ the manufacturer's standard deviation of repeatability(σr),and the standard deviation of precision(sl) was ≤the manufacturer's standard deviation of precision(σl).The precision was acceptable and similar to what the manufacturer declared.In the 2 levels of tested parameters,the fixed results [the mean results of quality control services(QCS)] were in the validation range,and the accuracy was consistent with what manufacturer declared.Conclusions The repeatability,precision and accuracy of the parameters by Modular DP system reach the performance that the manufacturer declares,and the performance of this biochemical analyzer has been verified.