THE SCREENING AND DIAGNOSTIC CUT-OFF VALUES FOR PRIMARY ALDOSTERONISM BASED ON LC-MS/MS: A PROSPECTIVE MULTI-CENTER STUDY IN CHINA

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Objective: This study aims to establish Chinese-specific cut-off values using liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) method for screening and confirmatory tests for primary aldosteronism (PA). Design and method: Through a prospective, multi-center study cohort, high-risk patients for PA underwent aldosterone-to-renin ratio (ARR) screening and drug washout, followed by captopril challenge test (CCT) and saline infusion test (SIT). Plasma aldosterone concentration (PAC), renin concentration (PRC) or renin activity (PRA) were measured using chemiluminescence (CLIA) and LC-MS/MS methods, and ARR was calculated. Based on the LC-MS/MS method, receiver operating characteristic (ROC) curves were plotted to determine the optimal cut-off points for screening and confirmatory tests in the entire population. The consistency of the results between screening and diagnostic tests was also compared. Results: In the multi-center study cohort, a total of 471 participants enrolled. Among them, 117 were diagnosed with PA. In the whole study cohort, the optimal cut-off value of ARR for screening test determined based on the maximum Youden's index, was set at 14.97 (ng/dl)/[ng/(ml·h)] (AUC: 0.841, 95% CI 0.800-0.882). At this cut-off value, the optimal cut-off value for exploring PAC was over 5ng/dl. As for CCT and SIT, ARR and PAC exhibited similar diagnostic performance (CCT p=0.295; SIT p=0.372), and were significantly superior to PRA (both p<0.001). Based on clinical practice and the maximum Youden's index, the optimal PAC cut-off value for CCT in the entire population was determined to be 3.96ng/dl (AUC: 0.837, 95% CI 0.796-0.878), and the optimal PAC cut-off value for SIT in the entire population was 4.09ng/dl (AUC: 0.852, 95% CI 0.815-0.889). When comparing CIT and SIT with screening ARR, there was no significant difference in diagnostic performance as reflected by the ROC curve (CIT vs screening p=0.329, SIT vs screening p=0.681). Conclusions: Based on the LC-MS/MS method, an ARR > 15(ng/dl)/[ng/(ml·h)] and PAC over 5ng/dl can be considered as ideal screening cut-off values for PA in the Chinese population. For confirmatory tests, both ARR and PAC exhibit similar diagnostic performance. Therefore, setting the PAC cut-off values at 3.96ng/dl and 4.09ng/dl has strong promotional value among Chinese individuals.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.