Abstract:Abstract: Objective:To evaluate the accuracy of measurement values for α-amylase in serum by routine methods. Methods:Four commercial reagents for α-amylase were selected to establish 11 α-amylase routine methods in Hitachi 7170 chemical analyzer including 4 approved test systems (A1, B1, C1 and D1) and 7 conventional methods (A2, B2, C2, D2, B3, C3 and D3). The levels of α-amylase in frozen human serum samples covering the range from 40 to 750 U/L were measured simultaneously by using IFCC reference method and 11 routine methods. The accuracy of measurement was evaluated according to the guideline of EP9-A2. The consistency of the results between each routine method and IFCC reference method was analyzed by the improved BlandAltman semi-graphical method. The accuracies of the measurement results of each routine method were evaluated comprehensively. Results:The regression equations of the measurement values between each routine method and IFCC reference method were Y=0.934X+0.886, Y=1.070X-6.249,Y=0.930X+5.388, Y=0.731X-3.574, Y=0.986X+0.996, Y=0.983X-6.195, Y=0.971X+6.957, Y=1.000X-4.649, Y=0.715X-4.648, Y=0.864X+4.821 and Y =0.757X-4.253, respectively. In the equations, X stood for the measurement values of IFCC reference method and Y stood for the measurement values of each routine methods. Eleven routine methods were evaluated by using IFCC reference method as the comparative method. The measurement results of the 4 methods, i.e., B1, A2, C2 and D2 were reliable. Conclusions:Using frozen human serum samples as calibrators should be an excellent solution for the accuracy of α-amylase values measured by routine methods.