2025 Volume 74 Issue 2 Pages 317-324
This study aimed to examine the basic performance of reagents for alkaline phosphatase (ALP) measurement using serum samples from patients undergoing hemodialysis using the IFCC standardization method (IFCC method) and former JSCC standardization method (JSCC method) and characteristics of activity values according to blood type and presence or absence of diabetes mellitus. Methods: Residual serum was obtained from patients undergoing hemodialysis in August 2023 using L-type Wako ALP/IFCC and ALP/J2 by the IFCC and JSCC method, respectively. The reagents were tested for concomitant accuracy, reproducibility in the laboratory, accuracy, dilution linearity, limit of quantification, influence of coexisting substances, correlation test as reagent performance tests, and ALP isozyme test to determine the difference in activity values between the blood type A/AB and B/O groups and in the presence of diabetes mellitus. In the basic performance test, the IFCC method showed good results in all tests; however, the JSCC method showed a negative error at high hemoglobin concentrations only in the hemolytic hemoglobin of the influence of the coexisting substances test. As a characteristic of blood groups, there was no difference in activity between the A/AB and B/O groups in the IFCC method; however, in the JSCC method, the activity was higher in the B/O group than in the A/AB group (p = 0.022). Among the isozymes, the B/O group had a higher percentage of the small intestinal type than the A/AB group (p < 0.001). Regarding the characteristics of patients with or without diabetes mellitus, there was no difference in activity values between the DM and non-DM groups using either the IFCC or JSCC methods, and isozymes. Conclusion: L-type Wako ALP/IFCC showed good reagent performance in serum from patients undergoing hemodialysis, suggesting that the difference in ALP values between the A/AB and B/O types was smaller than that of the JSCC method.
