IDS Cortisol Automated Assay

Products are for professional/laboratory use only.

The IDS Cortisol assay is a fully automated CLIA assay for the quantitative determination of cortisol in human serum and plasma samples. Results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland.

Cortisol is a steroid hormone synthesized in the adrenal gland regulating a variety of physiological processes ^2,3,4.

The IDS Cortisol results are to be used in conjunction with other clinical and laboratory data to assist clinicians in the diagnosis and treatment of disorders of the adrenal gland, such as hypo- and hyper-cortisolism, most commonly referred to as Addison’s disease and Cushing’s syndrome^,4,5.  Many common signs of Cushing’s such as obesity, high blood pressure, and increased blood glucose are frequently observed in today’s society⁶.

The Endocrine Society recommends the overnight dexamethasone suppression test as one of the screening tests for diagnosing Cushing’s syndrome⁷, with a cut-off of <1.8 µg/dL as indication of suppressed serum levels.  A peak cortisol <18 µg/dL following a standard-dose corticotropin stimulation test is indicative of adrenal insufficiency⁵.

 

Key Features:

• Traceable to the Joint Committee for Traceability in Laboratory Medicine (JCTLM)-listed LC-MS/MS Candidate Reference Measurement Procedure (cRMP)¹ for confidence in patient results
• Utilises direct antibody coating immunoassay principle, removing the risk of inaccurate results due to biotin interference
• Excellent functional sensitivity and precision over the clinically relevant range
• Efficient laboratory workflow, consolidating the testing of ACTH, Aldosterone and Direct Renin on one fully automated platform from one plasma sample tube

Product Factsheet:

Product Code:	IS-4600 / IS-4620 / IS-4630
Certification:	CE Marked
Clinical Area:	Hypertension (Endocrinology)
Type:	Automated
Format:	Automated Chemiluminescence Immunoassay (CLIA)
RUO/IVD:	IVD
Number of Tests:	100
Sample Type:	Serum and Plasma
Sample Volume:	30 µL
Assay Range:	0.59 (limit of quantitation) – 45 µg/dL

Publications:

1. Hawley JM et al. Candidate reference measurement procedure for the quantification of total serum cortisol with LC-MS/MS. Clin Chem 2016;62:262–9.
2. Ramamoorthy, S. & Cidlowski, J. A. Corticosteroids: Mechanisms of Action in Health and Disease. Rheumatic diseases clinics of North America 42, 15-31, (2016).
3. Wild, D. The immunoassay handbook. (Elsevier, 2005).
4. Cain, D. W. & Cidlowski, J. A. Specificity and sensitivity of glucocorticoid signalling in health and disease. Best practice & research. Clinical endocrinology & metabolism 29, 545-556, (2015).
5. Charmandari, E., Nicolaides, N. C. & Chrousos, G. P. Adrenal insufficiency. Lancet 383, 2152-2167, (2014).
6. Findling, J. W. & Raff, H. Cushing’s Syndrome: important issues in diagnosis and management. The Journal of clinical endocrinology and metabolism 91, 3746-3753, (2006).
7. Nieman, L. K. et al. The diagnosis of Cushing’s syndrome: an Endocrine Society Clinical Practice Guideline. The Journal of clinical endocrinology and metabolism 93, 1526-1540, (2008).