Cortisol Saliva Luminescence Immunoassay

Cortisol Saliva Luminescence Immunoassay is IVDR certified!

Luminescence Immunoassay for the in-vitro diagnostic quantitative determination of Cortisol in human saliva.

Intended use

The IBL International Cortisol Saliva Luminescence Immunoassay is intended for the in-vitro diagnostic quantitative determination of Cortisol in human saliva and for use as an aid in the diagnosis and treatment of adrenal disorders. he device is not intended for point-of-care settings.

The Cortisol Saliva Luminescence Immunoassay is intended for the quantitative determination of Cortisol in human saliva in adults and for use as an aid in the diagnosis and treatment of adrenal disorders. The information in addition to other clinical observations and diagnostic test is useful in assessing the level of adrenal function as a determination of physiological status in adults. The Cortisol Saliva Luminescence Immunoassay is based on the competition principle and measured on a microtiterplate luminescence reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as luminescence microplate reader/washer, vortexer and pipettes to execute the test. Test results may be calculated manually from a standard curve and compared to laboratory established reference ranges from healthy adults (i.e. normal ranges. The test kit is intended for professional laboratory use by trained personnel. The test kit is not for home or layperson use. The device is not intended for point-of-care settings.

Cortisol is the most important steroid hormone. It is produced by the adrenal cortex from low-density lipoprotein cholesterol via multiple steps of enzymatic reactions (Wild, 2013, Immunoassay Handbook p. 696). About 80% of the 17-Hydrocorticoidsteroids in circulation are cortisol, while 90% are protein-bound and the remaining is freely available, which is biologically active and can be measured in saliva, serum and urine [1]. Cortisol concentration underlies a diurnal fluctuation in adults, reaching a peak around 30-60 minutes after awakening, the Cortisol Response to Awakening, before the level is decreasing in the afternoon and remaining low until the next morning [2]. The cortisol measurement is indicated in diseases with abnormal gluco-corticoid production: hypercortisolism e.g. Cushing Syndrome [3; 4].Hypercortsiloism describes the overproduction of cortisol e.g. Cushing's Syndrome, while the underproduction is Hypocortisolism e.g. Addison’s disease, both will be addressed in more depth in the following paragraphs.Hypercortisolism, the clinical condition that results from excessive secretion of cortisol, is termed Cushing’s Syndrome (Wild, 2013). Cushing’s Syndrome is more common in women, and the chronic excess of cortisol can lead to a number of symptoms and signs including obesity, easy bruising, purple abdominal striae, hirsutism, acne and greasy skin, hypertension, muscular weakness, menstrual disturbances, depression, and osteoporosis [3; 5; 6].While adrenal insufficiency, hypocortisolism, is manifested in primary adrenal insufficiency e.g. Addison’s disease. Thomas Addison described a group of patients with anemia and diseased adrenal glands, which is now known as primary adrenal insufficiency or also cited as Addison’s disease (Michels and Michels, 2014) [7].

*Product availability and regulatory status may vary across regions outside the EU depending on local country-specific registration. CE IVD under IVDR to be launched soon. Consult with your Tecan associate for further information.

For concrete data please consult the Instruction for Use in the download box on the top right side.