(162 days)
An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free cortisol (hydrocortisone and hydroxycorticosterone) in saliva. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.
The DRG Salivary Cortisol ELISA KIT is based on the competition principle and the microplate separation. An unknown amount of Cortisol present in the sample and a fixed amount of Cortisol coniugated with horseradish peroxidase compete for the binding sites of mouse polyclonal Cortisol-antiserum coated onto the wells. After one hour incubation the microplate is washed to stop the competition reaction. After addition of the TMB substrate solution the concentration of Cortisol is inversely proportional to the optical density measured.
Here's an analysis of the provided text regarding the DRG Salivary Cortisol ELISA, focusing on acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the performance data presented, as explicit criteria (e.g., "must achieve X correlation") are not stated. The performance is reported against other commercially available methods or standard analytical techniques.
| Performance Metric | Implied Acceptance Criteria (Based on context) | Reported Device Performance |
|---|---|---|
| Method Comparison (vs. LIA) | High correlation (e.g., >0.85) | 0.872 (Study 1, n=114) |
| High correlation (e.g., >0.95) for expanded study | 0.9795 (Expanded Study 1, n=40) | |
| Method Comparison (vs. EIA) | High correlation (e.g., >0.90) | 0.936 (Study 2, n=72) |
| High correlation (e.g., >0.95) for expanded study | 0.9920 (Expanded Study 2, n=40) | |
| Method Comparison (vs. LC-MS) | High correlation (e.g., >0.85) | 0.89056 (Study 3, n=28) |
| Sensitivity (Lowest Detectable Limit) | As low as reasonably achievable for clinical utility (no specific numerical criterion given) | 0.537 ng/mL or 0.0537 ug/dl at 95% confidence limit |
| Specificity (Cross-Reactivity) | Low cross-reactivity with structurally similar compounds | Cortisol: 100%, Corticosterone: 29.00%, Cortisone: 3.00%, most others |
§ 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system.
(a)
Identification. A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.(b)
Classification. Class II.