ArticlePractical laboratory medicine2025
Comparative evaluation of four new immunoassays and LC-MS/MS for the measurement of urinary free cortisol in Cushing's syndrome diagnosis.
Article in Practical laboratory medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Objectives: Twenty-four-hour urinary free cortisol (UFC) measurement is the initial diagnostic test for Cushing's syndrome (CS). We compared UFC determination by four new immunoassays using Autobio A6200, Mindray CL-1200i, Snibe MAGLUMI X8 and Roche 8000 e801 with liquid chromatography-tandem mass spectrometry (LC-MS/MS). Additionally, we evaluated the value of 24-h UFC measured by four direct immunoassays for diagnosing CS. Methods: Residual 24-hr urine samples of 94 CS and 243 non-CS patients collected from previous cohort were used. A laboratory-developed LC-MS/MS method was used as reference. UFC was measured by immunoassays using Autobio, Mindray, Snibe and Roche platforms. Method was compared using Passing-Bablok regression and Bland-Altman plot analyses. Cut-off values for each assay and corresponding sensitivities and specificities were calculated by ROC analysis. Results: All four immunoassays showed strong correlations with LC-MS/MS (Spearman coefficient r = 0.950, 0.998, 0.967, and 0.951, respectively). All immunoassays showed proportionally positive bias. The areas under the curve were 0.953 for Autobio, 0.969 for Mindray, 0.963 for Snibe, and 0.958 for Roche. The cut-off values varied from 178.5 to 272.0 nmol/24 h). Assay sensitivity and specificity ranged from 89.66 % to 93.10 % and from 93.33 % to 96.67 %, respectively. Conclusions: Four newly available direct immunoassays for measuring UFC show good analytical consistency compared to LC-MS/MS. The elimination of organic solvent extraction simplifies workflows while maintaining high diagnostic accuracy. Additionally, they exhibited similarly high diagnostic accuracy for CS identification. Future multi-center studies are needed to validate our findings and establish method-specific UFC cut-off values to enhance clinical utility.
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