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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. The device is not intended for point-of-care settings.

Cortisol (also known as hydrocortisone, compound F) is the main glucocorticoid in humans and is produced in the zona fasciculata of the adrenal cortex. 90 % of the circulating cortisol are bound to corticoid binding globulin (CBG, Transcortin), ca. 7 % are bound to albumin and only 1-3 % are unbound. Only the latter part represents the active form of cortisol. The free cortisol is released in saliva and is excreted via the kidneys as a small part among the metabolites of cortisol. The level of free cortisol in blood regulates mainly its secretion in the adrenal cortex in a negative feedback mechanism via CRH (corticotropin releasing hormone) in the hypothalamic region and the ACTH in the pituitary gland, but it is also affected by different situations above all by stress. In humans, there is a physiological fluctuation of cortisol achieving the highest level in the morning and the lowest during the night. This fluctuation of cortisol plasma level is reflected in saliva normally with a peak in the first 90 minutes after waking up. The cortisol measurement is indicated in adrenal disorders. Due to the diurnal fluctuations of cortisol, a salivary sample collection is an easy method without the stress of repeated venipunctures. Test principle: Luminescence immunoassay based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labelled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve. Device composition: The device is available in two sizes, 96 tests and 960 tests. The device consists of an antibody coated 96 well Microtiter Plate, seven Standards (range 0.015 - 3.20 µg/dL, equivalent to 0.15 - 32 ng/mL calibrated to the NIST cortisol), two Controls, Enzyme Conjugate (Cortisol coupled to peroxidase), Chemiluminescence Reagent 1 and 2, 10x concentrated Wash Buffer, Adhesive Foils.

For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.

The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.

Immunoassay for the in vitro quantitative determination of cortisol in human serum, plasma, urine, and saliva. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys Cortisol CalSet is used for calibrating the quantitative Elecsys Cortisol assay on the Elecsys immunoassay analyzers.

(1) The Elecsys Cortisol Assay is a two step competitive immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. (2) The Elecsys Cortisol CalSet is a lyophilized product consisting of human serum with added cortisol (synthetic) in two concentration ranges. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

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.

The Elecsys Cortisol is an immunoassay for the in-vitro quantitative determination of cortisol in serum, plasma, urine and saliva. The determination of cortisol is used for the recognition and treatment of functional disorders of the adrenal gland. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the Roche Elecsys 1010/2010 and MODULAR ANALYTICS E170 (Elecsys module) immunoassay analyzers.

The Elecsys Cortisol Assay is a two step sandwich immunoassay with streptavidin microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code.

Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.

Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared. Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.