Secaucus – October 19, 2026 -- A broader set of lab criteria identified primary aldosteronism (PA) in 26.2% of 60,449 U.S. patients, twice the 13.0% flagged under the Endocrine Society's 2025 guidelines, according to a Quest Diagnostics (NYSE: DGX) study published in the journal Hypertension.
Study compares 2025 guideline cutoffs with a permissive threshold
Researchers from Quest Diagnostics, Mass General Brigham, Harvard Medical School and the University of Texas Southwestern Medical School analyzed deidentified Quest lab results. The 2025 criteria require plasma renin activity (PRA) of 1 ng/mL/h or lower, aldosterone of at least 7.5 ng/dL and an aldosterone-to-renin ratio (ARR) above 15. The permissive criteria keep the PRA limit, set aldosterone above 5 ng/dL and drop the ARR requirement.
The authors describe the 2025 guidelines as "overly restrictive," with cutoffs that capture only the most advanced cases.
Missed patients mostly fall below the aldosterone cutoff
Of the additional patients identified by the permissive criteria, 79.0% were missed because their aldosterone levels sat between 5 and 7.5 ng/dL, below the Endocrine Society threshold. About one in five met the aldosterone criterion but failed the ARR threshold.
Clinical markers track with the broader criteria
Conditions consistent with PA, including hypertension, hypokalemia and atrial fibrillation (based on insurance claim billing), were enriched among patients flagged by the permissive cutoffs. Within that group, patients with PRA below 0.5 ng/mL/hr had 1.27 times higher odds of hypertension than those with higher or normal PRA (P 0.0001). Patients with PRA below 0.25 ng/mL/hr had 2.62 times higher odds of atrial fibrillation (P = 0.0032).
Authors urge treating PA as a spectrum
Lead author Marco Marcelli, MD, Medical Director at Quest Diagnostics, said the guidelines are optimized for advanced disease and may be less sensitive for earlier or milder forms. He said some patients spend years seeking a diagnosis for a treatable condition. The study frames PA as a spectrum rather than a binary diagnosis, with earlier detection potentially preventing long-term cardiovascular complications.
Prevalence estimates could rise if prospective studies confirm
PA affects as many as 5-10% of adults with high blood pressure. If prospective studies confirm the Quest group's criteria, up to 25-30% of hypertension patients could be diagnosed with PA. High blood pressure affects nearly half of U.S. adults, almost 120 million people. A 2024 Quest study in Hypertension had already indicated PA is likely under-detected.
The authors cite the large cohort as a strength. Limitations include the retrospective design and the lack of confirmatory testing.