The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.
Saliva testing is a non-invasive alternative to blood tests for measuring cortisol, a key hormone for assessing endocrine status and diagnosing conditions like Cushing's syndrome. It accurately reflects physiologically active free cortisol. However, its clinical use is hampered by extremely low cortisol concentrations and the lack of reliable detection methods. We have developed two advanced technologies: an immunomagnetic-bead-based LC-MS assay with simplified preparation, and a fluorescence immunoassay system for point-of-care testing. To promote their clinical adoption, this study will establish normal reference intervals of salivary cortisol for both methods in a healthy population and optimal cut-offs in cases of Cushing's sydrome and adrenal insufficiency.
Study Type
OBSERVATIONAL
Enrollment
220
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGReference intervals of salivary cortisol
Salivary cortisol levels were evaluated by immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system to establish its reference intervals according to the 2.5th and 97.5th percentiles.
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome
The diagnostic cut-off for each analysis method was defined as either the calculated upper reference interval (97.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for Cushing's syndrome was calculated using samples from all available healthy controls and cases.
Time frame: 23:00 on the day of sample collection
Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency
The diagnostic cut-off for each analysis method was defined as either the calculated lower reference intervals (2.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for adrenal insufficiency was calculated using samples from all available healthy controls and cases.
Time frame: 8:00 on the day of sample collection
Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency
The diagnostic accuracies of the fluorescence immunoassay system and the immunomagnetic-bead-based LC-MS assay were compared by analyzing their areas under the receiver operating characteristic (ROC) curves using DeLong's test for paired statistics.
Time frame: 8:00 or 23:00 on the day of sample collection
Agreement in assessment of salivary cortisol
To assess the agreement in assessment of salivary cortisol between immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system
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Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different age ranges
Comparsion of salivary cortisol levels in subgroups of age
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different sex
Comparsion of salivary cortisol levels in subgroups of sex
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different body mass index ranges
Comparsion of salivary cortisol levels in subgroups of body mass index
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection