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Intended purpose
The function of this device is to aid in the diagnosis of several conditions by the determination of Cortisol and Cortisone levels in 24h human urine, performed by automated quantitative LC-MS assay technology. Deviant measurand values can be an indication of the following physiological or pathological states and/or conditions:
Cortisol:
Cortisone:
Summary
Urinary free cortisol (UFC) analysis represents the first biochemical laboratory approach for th screening of endogenous Cushing’s syndrome (CS). Endogenous CS is caused by prolonge exposure to elevated levels of endogenous cortisol that may occur from excess production by one or both adrenal glands, or from overproduction of the adrenocorticotropic hormone (ACTH), which normally regulates cortisol production.
As symptoms are always non-specific, including hypertension, truncal obesity and mood disorders, specific biochemical tests are required for diagnosing CS.
One of the first-line tests for diagnosis, the measurement of 24-h UFC, can also be useful in other clinical conditions characterized by a high urine cortisol level, such as in non-autonomous hypercortisolism (pseudo-CS), psychiatric disorders, morbid obesity, poorly controlled diabetes mellitus and alcoholism. Altered cortisol metabolism is also responsible for a condition called apparent mineralocorticoid excess (AME) syndrome. Type 2 11β-hydroxysteroid dehydrogenase (11β-HSD) regulates the cortisol level by oxidizing it to its inactive form, cortisone.
While cortisol is mainly essentially secreted by the adrenal gland, cortisone is mainly produced by 11β-HSD type 2 in multiple human tissues, which interconverts bioactive cortisol to hormonally inactive cortisone to prevent activation of the mineralocorticoid receptor by cortisol. Hence the simultaneous determination of cortisol and cortisone can help in the diagnosis of AME syndrome, but also in congenital adrenal hyperplasia and adrenal insufficiency.
Manufactured by Diagnotix; Distributed by Tecan, IBL International GmbH.
For concrete data please consult the Instruction for Use in the download box on the top right side.
For concrete data please consult the Instruction for Use in the download box on the top right side.
Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.
And as experts in laboratory automation, we can support our customers with the protocols for open ELISA platforms, such as the Freedom EVOlyzer or Thunderbolt®.
All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use.
All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).
As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.
Our range of high-quality immunoassays is supported by a diverse portfolio of automated solutions, making us the perfect partner for you and your customers.
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