Performance evaluation of chemiluminescence enzyme immunity method using measurement reagent aldosterone: Validity evaluation of the aldosterone reagent by the CLEIA method

Abstract

Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is an attractive alternative to the radioimmunoassay (RIA) method; however, discordance between non-RIA and RIA measurement results has been reported. Here, we aimed to evaluate the performance of the chemiluminescence enzyme immunoassay (CLEIA) for aldosterone (FUJIREBIO Inc.) detection. The correlation of the conventional method (x) and CLEIA (y) for aldosterone was y = 1.46x + 53.63, r = 0.976. No significant difference was observed between the CLEIA results and the LC-MS/MS results. However, when the RIA results were compared with the CLEIA and LC-MS/MS results, significantly larger differences were observed. Our results revealed that CLEIA showed a good correlation with LC-MS/MS and thus the basic performance of the “Lumipulse aldosterone” reagent was considered to be sufficient.