Comparison of three different chemiluminescence assays and a rapid liquid chromatography tandem mass spectrometry method for measuring serum aldosterone.

Abstract

Background This study aimed to quantify and compare serum aldosterone (sALD) levels through three different chemiluminescence immunoassays (CLIAs) and liquid chromatography tandem mass spectrometry (LC-MS/MS) analysis. Methods Serum samples from 221 patients with suspected primary aldosteronism (PA) were retrospectively included in this study conducted at the Peking Union Medical College Hospital from June to August in 2017. sALD levels were determined using the LC-MS/MS method and three different CLIA systems, viz., DiaSorin® XL, iSYS and Auto Lumo A2000. Pooled fresh serum samples were used for recalibration. Passing-Bablok regression analysis, correlation matrix, and Bland-Altman plots were used to evaluate the concurrence among ALD levels determined using the three CLIAs. Results Within-laboratory precision of the four assays ranged from 2.1% to 9.4%, except the coefficient variation (CV) of one of the CLIAs, which exceeded 20.0% for samples with low sALD levels. sALD levels determined using LC-MS/MS were significantly lower than those determined using the other three CLIAs (p < 0.0001). Spearman's correlation coefficient of the four assays ranged from 0.745 to 0.950 (p < 0.0001). The Bland-Altman plot showed that the average bias (%) for the three CLIAs and LC-MS/MS ranged from -69.3 to -49.2. After recalibration, this correlation did not improve among the assays. However, the bias and bias percentage at the medical decision level improved between LC-MS/MS and DiaSorin® XL/iSYS. Conclusions Significant inconsistencies between the results of CLIAs and LC-MS/MS indicate that different sALD measures cannot be used interchangeably.