Cortisol Saliva ELISA

instructions for use	certificate	MSDS
Deutsch English Español Français Italiano Magyar Português	ECO168 ECO169 ECO169U ECO170	Dansk Deutsch English Español Français Italiano Magyar Português

Cortisol Saliva ELISA is IVDR compliant!

Intended use

Enzyme immunoassay for the quantitative determination of free Cortisol in human saliva.

Intended purpose

The Cortisol Saliva ELISA 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 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 Saliva ELISA is not intended for near-patient testing.

Summary and explanation

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]

Hypercortisolism, the clinical condition that results from excessive secretion of cortisol, is termed Cushing’s Syndrome, while the underproduction in hypocortisolism e.g. Addison’s disease, both will be addressed in more depth in the following paragraphs.

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].

Salivary cortisol determinations have gained a wider acceptance in psychobiology, stress and sports medicine studies.[5; 6] Their use is based on the assumption that salivary cortisol is a reasonable reflection of hypothalamic-pituitary-adrenal (HPA) axis function. Late-night salivary cortisol (LNSC) is a reliable method to rule in or rule out Cushing’s disease. Indeed, in the diagnostic setting, salivary cortisol levels parallel those in plasma following ACTH and CRH stimulation, and following exercise induced stress.[8; 9]

Sensitive and reliable

The new IBL International Cortisol Saliva ELISA kit is an excellent alternative to the current complex and relatively expensive LC-MS/MS method to determine cortisol in saliva as accurately as possible.

Advantages of the IBL Cortisol Saliva ELISA

Calibration to the LC-MS/MS reference method;
IBL-ELISA = 1.015 x LCMS-0.028, R=0.99
As few as 6 standards and 2 controls;
Simple processing;
Clearly defined reference values.

Diurnal rhythm

The normal cortisol levels in human saliva depend on the time of day. The timing of the cortisol peak, however, does not depend on the actual time of day or daylight, but correlates with the usual wake-up time. The new reference ranges have been carefully determined on the basis of 100 day profiles. Starting with batch no. ECO137, the following reference values have to be considered:

Time after awakening(h)	Cortisol (saliva) Range - RE52611
	(♂/♀; > 6y; n= 100; 5%-95% percentile)
	Median	Range (µg/dL)		Median	Range (nmol/L)
	(µg/dL)	5%	95%	(nmol/L)	5%	95%
Awakening	0.343	0.113	0.803	9.47	3.12	22.17
0.5	0.478	0.200	1.076	13.19	5.52	29.70
1	0.384	0.101	0.936	10.60	2.79	25.82
2	0.234	0.083	0.574	6.44	2.29	15.85
5	0.150	0.074	0.355	4.14	2.04	9.79
8	0.116	0.055	0.314	3.20	1.53	8.67
12	0.082	0.032	0.322	2.26	0.87	8.89

Sensitive and reliable

The investigation of cortisol in saliva is indicated in the diagnostic work-up of clinical issues in various scientific/medical fields, particularly endocrinology, psychology, sports medicine, pediatrics, anti-aging medicine and veterinary medicine

Measuring the free cortisol levels in saliva is a very simple and convenient way to check the function of the adrenal gland. Persistently elevated or decreased cortisol levels are often found in patients with adrenal dysfunction. Adrenal dysfunction can occur in many other diseases, such as fibromyalgia, hypothyroidism, chronic fatigue syndrome and premature menopause.
The salivary cortisol test can also be used in patients with conditions such as reduced stress tolerance, fatigue, sleep disorders and depression.

Standardized reagents

Our Saliva ELISA product line has been revised so that the main steroids (cortisol, testosterone, progesterone, DHEA) may be processed in a similar way:

The substrate, washing and stop solutions are interchangeable;
The enzyme conjugate, the substrate and stop solutions are uniformly pipetted with 100 µL;
The kits contain as few as 6 standards and 2 controls;
Only 50 µL sample volume are required;
All kits use the same sample diluent buffer.

Thanks to the similar processing and assembling, the assays can easily be performed in combination.

*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.