2025 Volume 74 Issue 3 Pages 504-511
Autotaxin (ATX) levels increase in the blood during liver fibrosis and can identify fibrosis earlier than conventional liver fibrosis markers. In this study, we conducted a basic performance and clinical performance evaluation of “ATX Autowako,” released by Fujifilm Wako Pure Chemical Corporation. The measurement instrument used was the LABOSPECT 008 α (Hitachi High-Tech). Basic investigations included reproducibility, linearity, quantitation limit, influence of coexisting substances, correlation (plasma and control instruments/reagents: FEIA method), and sample storage stability. Additionally, as part of the clinical performance evaluation, we examined differences in ATX activity values according to sex and age groups. A total of 240 subjects (120 males and 120 females) with normal liver function were included, excluding patients with rheumatoid arthritis and cancer. The results of basic performance evaluation were satisfactory. In the clinical performance evaluation, consistent with previous reports, ATX levels were higher in females than in males, with no age-related differences. The evaluated reagent is suitable for use with a general automatic biochemistry analyzer, making it cost-effective for introduction and we believe it is useful as a reagent that can be assessed similarly to existing ones.