Background: Primary aldosteronism (PA) is characterized by excessive, autonomous secretion of aldosterone which fails to suppress upon administration of fludrocortisone and/or salt loading. Seated saline suppression testing (SSST) was recently reported to be superior to recumbent.1 The recommended diagnostic cut-off 4-hour plasma aldosterone concentration (PAC; 162 pmol/L) for SSST was based on that measured by HPLC-MS/MS. Most diagnostic laboratories, however, use immunoassays to measure PAC.
Objective: To define the optimal cut-off PAC measured by immunoassay for the diagnosis of PA using SSST.
Methods: This study involved 80 of the 85 SSST studies whose data were used to originally define the optimal HPLC-MS/MS cut-off. PA was confirmed in 65 (23 unilateral, 34 bilateral and 8 subtype yet to be determined) by positive fludrocortisone suppression testing (FST) and/or lateralization on adrenal venous sampling and excluded in 15 (12 cured of PA post-adrenalectomy and 3 non-PA) by negative FST. PAC was measured by a chemiluminescence immunoassay (PACIA) using the DiaSorin Liaison XL analyzer.
Results: Receiver operating characteristics analysis revealed good performance (AUC = 0.893; P<0.001) of the 4-hour PACIA for the diagnosis of PA and an optimal diagnostic cut-off of 171 pmol/L, with sensitivity and specificity of 95.4% and 80.0% respectively (Youden index = 0.754). Using this cut-off, none of the three subjects with false-negative SSST had unilateral PA. The cut-off with the next highest Youden index (0.728) was 217 pmol/L and demonstrated lower sensitivity (86.2%) but higher specificity (86.7%). PACIA measurements strongly correlated with PAC measured by HPLC-MS (Pearson correlation coefficient r = 0.94, P<0.001).
Conclusions: A higher diagnostic cut-off level for SSST should be employed when PAC is analyzed by immunoassay compared to that by HPLC-MS/MS.
Reference. 1. Stowasser M, et al. Comparison of seated with recumbent saline suppression testing for the diagnosis of primary aldosteronism. J Clin Endocrinol Metab 2018;103:4113-24.