2023 Volume 72 Issue 1 Pages 97-104
The soluble interleukin-2 receptor (sIL-2R) is considered to be useful as a diagnostic aid for non-Hodgkin’s lymphoma and adult T-cell leukemia, as well as for determining therapeutic efficacy. In this study, Tosoh Corporation has developed a reagent for chemiluminescent enzyme immunoassay (CLEIA) that can be used in 15 min. In this study, we evaluated the basic performance of this reagent using the fully automated CLEIA system AIA®-CL1200. As a result, the reproducibility, selectivity, and limit of quantitation using this reagent were found to be high, and dilution linearity test was confirmed up to 44,131 U/mL. The correlation with other methods was good, and no extremely deviated sample was found using LUMIPULSE based on the same measurement principle were observed. However, in comparison with Nanopia which uses latex immunoturbidimetry as its principle, two divergent cases were identified in which Nanopia showed higher values. The results of the analysis suggest that IgM in sample 1 was involved in the assay reaction system, and in sample 2, it was possible that Human anti-mouse antibody (HAMA) in this sample caused the nonspecific reaction. The basic performance of this reagent is good, and it is expected to contribute to clinical diagnostics since it has sufficient performance for routine examinations.
