What is the clinical evidence from this study?

Study design: Cross-Sectional. Population: Hypertension with suspected primary aldosteronism (n=1235). Intervention: Seated plasma aldosterone concentration (PAC) > 20 ng/dL vs. Saline infusion test (SIT). Primary outcome: Specificity of seated PAC > 20 ng/dL for diagnosing primary aldosteronism (95% CI 94.46% - 98.09%).

What does this research mean for the field?

Suppression testing for primary aldosteronism can be bypassed if seated plasma aldosterone concentration (PAC) is greater than 20 ng/dL in patients with positive screening results. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.CHALLENGES_CONSENSUS.

What question did this study set out to answer?

The research aims to assess simplified diagnostic strategies for primary aldosteronism by evaluating plasma aldosterone concentration and hypokalemia.

March 17, 2026Open Access

Evaluating simplified confirmation strategies for primary aldosteronism diagnosis

Key Result

A seated plasma aldosterone concentration > 20 ng/dL demonstrated 96.61% specificity for diagnosing primary aldosteronism in patients with a positive screening test.

Key Points

The research aims to assess simplified diagnostic strategies for primary aldosteronism by evaluating plasma aldosterone concentration and hypokalemia.
Cross-sectional study design
Included 1,235 patients diagnosed with primary aldosteronism
Evaluated plasma aldosterone concentration and hypokalemia for diagnostic efficacy
Patient data collected between December 2020 and December 2023
PAC > 30 ng/dL showed 100% specificity and PPV in positive screening tests
PAC > 20 ng/dL had a specificity of 96.61% and sensitivity of 31.27%
Among normokalemic patients, PAC > 30 ng/dL had 100% specificity and PPV
In hypokalemic patients, PAC > 20 ng/dL also showed 100% specificity and PPV

Study Design

Type

Cross-Sectional (n=1,235)

Multicenter

Structured PICO

Does a seated PAC > 20 ng/dL accurately diagnose primary aldosteronism and allow bypassing of suppression testing in hypertensive patients with a positive screening test?

Population

1,235 adult patients (≥18 years) with hypertension and a positive screening test for primary aldosteronism (PAC > 12 ng/dL and PRA < 1.0 ng/mL/h or ARR ≥ 20) who underwent a saline infusion test, median age 54, 40% male, based in China.

Intervention

Diagnostic strategy using seated plasma aldosterone concentration (PAC) cut-offs (e.g., >20 ng/dL, >30 ng/dL) and presence of spontaneous hypokalemia to bypass suppression testing.

Comparator

Saline infusion test (SIT) as the reference standard confirmatory test (primary aldosteronism defined as post-SIT PAC ≥ 10 ng/dL).

Outcome

Diagnostic efficacy (specificity, sensitivity, positive predictive value, negative predictive value, and accuracy) of seated PAC and spontaneous hypokalemia for diagnosing primary aldosteronism.

A seated plasma aldosterone concentration > 20 ng/dL provides high specificity for diagnosing primary aldosteronism, suggesting suppression testing can be safely bypassed in these patients.

Limitations

Did not perform multivariable adjustment for potential confounders such as age, sex, or BMI
Single-center study design

Abstract

The diagnostic process for primary aldosteronism (PA) is cumbersome, encompassing screening, suppression testing, and subtype differentiation. Current guidelines indicate that patients with hypokalemia may bypass suppression testing if plasma aldosterone concentration (PAC) > 20 ng/dL and renin is suppressed (plasma renin activity (PRA) below the detection limit or direct renin concentration (DRC) ≤ 8.2 mU/L). The 2025 Endocrine Society guideline further suggests that suppression testing can be omitted for patients without surgical intention, allowing direct initiation of mineralocorticoid receptor antagonist therapy. Nevertheless, these criteria remain restrictive or poorly defined. Consequently, a more universally applicable simplified diagnostic strategy is needed, particularly because hypokalemia occurs in fewer than 40% of PA cases. This study was a cross-sectional study. A total of 1,235 patients with hypertension, who visited the Hypertension Department of Xinjiang Uygur Autonomous Region People’s Hospital from December 2020 to December 2023 and were diagnosed with PA by saline infusion test (SIT), were enrolled. This study evaluated two indicators: PAC and the presence of spontaneous hypokalemia, in terms of their diagnostic efficacy for PA. Patients with positive screening test and seated PAC of > 30 ng/dL showed the highest specificity at 100% (95% CI 99.17–100.00%) and positive predictive value (PPV) at 100% (95% CI 94.87–100.00%), The minimum acceptable were PAC of > 20 ng/dL showed specificity at 96.61% (95% CI 94.46–98.09%) and Sensitivity at 31.27% (95% CI 28.06–34.63%); In Among patients with normokalemia, PAC > 30 ng/dL showed the highest specificity at 100% (95% CI 98.99–100.00%) and PPV at 100% (95% CI 85.75–100.00%), The minimum acceptable were PAC of > 20 ng/dL showed specificity at 95.88% (95% CI 93.29–97.68%); Among patients with hypokalemia, PAC > 20 ng/dL showed the highest specificity at 100% (95% CI 95.38–100.00%) and PPV at 100% (95% CI 97.22–100.00%). Our study shows among patients with positive results from the screening, suppression testing for PA can bypass if seated PAC > 20 ng/dL.

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