Cortisol ELISA

Cortisol ELISA is being IVDR certified!

Enzyme immunoassay for the quantitative determination of cortisol in human serum and plasma (EDTA, heparin, citrate). The Cortisol ELISA is intended for the quantitative determination of cortisol in human serum and plasma (EDTA, heparin, citrate) 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 ELISA is a solid phase enzyme-linked immunosorbent assay (ELISA), based on the principle of competitive binding and measured on an absorbance reader. The assay is semi-automated requiring general purpose laboratory instruments and consumables such as absorbance microplate reader/washer, vortexer and pipettes to execute the test. The assay is adaptable by laboratory personnel to automate on open ELISA based liquid handler platforms; the programming of the steps and timing required must be verified by the laboratory. Test results are calculated 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 self-testing. The Cortisol ELISA is not intended for near-patient testing. Cortisol is a very important steroid hormone. It is produced by the adrenal cortex from low-density lipoprotein cholesterol via multiple steps of enzymatic reactions.¹ About 80% of the 17-hydrocorticoidsteroids in circulation is cortisol. Circulating cortisol is 90% protein-bound and the remaining is freely available, which is biologically active and can be measured in serum and plasma (EDTA, heparin, citrate).² Cortisol concentration underlies a diurnal fluctuation in adults, reaching a peak around 30 to 60 minutes after awakening, the cortisol response to awakening, before the level is decreasing in the afternoon and remaining low until the next morning.³ Cortisol measurement is indicated in diseases with abnormal glucocorticoid production e.g., Cushing Syndrome. ⁴ Midnight serum cortisol and dexamethasone suppression tests are well-established methods to rule in or rule out Cushing’s disease. Additional information about patient population, testing algorithms, or interferences that may alter levels of cortisol binding globulin or the metabolism of dexamethasone are given in the guidance document of the international endocrine society.⁴ Cortisol levels are affected by exposure to stressful conditions.1 To avoid implications on the biochemical examination of patients, stressful conditions should be minimized. To investigate a potential lack of cortisol associated with adrenal insufficiency, morning cortisol levels or cortisol levels after corticotropin stimulation are evaluated e.g. Addison disease. Additional information about patient population and testing algorithms for adrenal insufficiency are given in the guidance document of the international endocrine society.⁵

*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.