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Test ID: CORTU
Cortisol, Free, Urine

Secondary ID A test code used for billing and in test definitions created prior to November 2011

8546

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Preferred screening test for Cushing syndrome

 

Diagnosis of pseudo-hyperaldosteronism due to excessive licorice consumption

 

This test has limited usefulness in the evaluation of adrenal insufficiency

Special Instructions and Forms Describes specimen collection and preparation information, test algorithms, and other information pertinent to test. Also includes pertinent information and consent forms to be used when requesting a particular test

Method Name A short description of the method used to perform the test

Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Cortisol, Free, U

Aliases Lists additional common names for a test, as an aid in searching

17-Hydroxycorticosteroids (See Q&A)
17-Hydroxycorticosteroids
17-Ketogenic Steroid (see Q&A)
Cortisol Free Urine
Free Urinary Cortisol
Urinary Free Cortisol
17-Ketogenic Steroid

Specimen Type Describes the specimen type needed for testing

Urine

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Container/Tube: Plastic, 10-mL urine tube (Supply T068)

Specimen Volume: 5 mL

Collection Instructions:

1. Collect urine for 24 hours.

2. Add 10 g of boric acid as preservative at start of collection.

Additional Information:

1. 24-Hour volume is required.

2. See Urine Preservatives in Special Instructions for multiple collections.

 

Urine Preservative Collection Options

Ambient

No

Refrigerated

Yes

Frozen

Yes

6N HCl

No

50% Acetic Acid

Yes

Na2CO3

Yes

Toluene

Yes

6N HNO3

No

Boric Acid

Preferred

Thymol

Yes

Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

3 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

NA

Lipemia

NA

Icterus

NA

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
UrineRefrigerated (preferred)7 days
 Frozen 14 days
 Ambient 7 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Cortisol is a steroid hormone synthesized from cholesterol by a multienzyme cascade in the adrenal glands. It is the main glucocorticoid in humans and acts as a gene transcription factor influencing a multitude of cellular responses in virtually all tissues. Cortisol plays a critical role in glucose metabolism, maintenance of vascular tone, immune response regulation, and in the body's response to stress. Its production is under hypothalamic-pituitary feedback control.

 

Only a small percentage of circulating cortisol is biologically active (free), with the majority of cortisol inactive (protein bound). As plasma cortisol values increase, free cortisol (ie, unconjugated cortisol or hydrocortisone) increases and is filtered through the glomerulus. Urinary free cortisol (UFC) in the urine correlates well with the concentration of plasma free cortisol. UFC represents excretion of the circulating, biologically active, free cortisol that is responsible for the signs and symptoms of hypercortisolism.

 

UFC is a sensitive test for the various types of adrenocortical dysfunction, particularly hypercortisolism (Cushing syndrome). A measurement of 24-hour UFC excretion, By liquid chromatography-tandem mass spectrometry (LC-MS/MS), is the preferred screening test for Cushing syndrome. LC-MS/MS methodology eliminates analytical interferences including carbamazepine (Tegretol) and synthetic corticosteroids, which can affect immunoassay-based cortisol results.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

0-2 years: not established

3-8 years: 1.4-20 mcg/24 hours

9-12 years: 2.6-37 mcg/24 hours

13-17 years: 4.0-56 mcg/24 hours

> or =18 years: 3.5-45 mcg/24 hours

 

Use the factor below to convert from mcg/24 hours to nmol/24 hours:

 

Conversion factor

Cortisol: mcg/24 hours x 2.76=nmol/24 hours (molecular weight=362.5)

Interpretation Provides information to assist in interpretation of the test results

Most patients with Cushing syndrome have increased 24-hour urinary excretion of cortisol. Further studies, including suppression or stimulation tests, measurement of serum corticotrophin concentrations, and imaging are usually necessary to confirm the diagnosis and determine the etiology.

 

Values in the normal range may occur in patients with mild Cushing syndrome or with periodic hormonogenesis. In these cases, continuing follow-up and repeat testing are necessary to confirm the diagnosis.

 

Patients with Cushing syndrome due to intake of synthetic glucocorticoids should have suppressed cortisol. In these circumstances a synthetic glucocorticoid screen might be ordered (SGSU/81035 Synthetic Glucocorticoid Screen, Urine).

 

Suppressed cortisol values may also be observed in primary adrenal insufficiency and hypopituitarism. However, many normal individuals may also exhibit a very low 24-hour urinary cortisol excretion with considerable overlap with the values observed in pathological hypocorticalism. Therefore, without other tests, 24-hour urinary cortisol measurements cannot be relied upon for the diagnosis of hypocorticalism.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

Acute stress (including hospitalization and surgery), alcoholism, depression, and many drugs (eg, exogenous cortisone, anticonvulsants) can obliterate normal diurnal variation, affect response to suppression/stimulation tests, and increase baseline levels.

 

This test has limited usefulness in the evaluation of adrenal insufficiency.

 

This methodology (liquid chromatography-tandem mass spectrometry: LC-MS/MS) eliminates analytical interferences including carbamazepine (Tegretol) and synthetic corticosteroids.

 

Renal disease (decreased excretion) may cause falsely low 24-hour urinary free cortisol values.

 

Improper collection may alter results. For example, a missed morning collection may result in false-negative tests; an extra morning collection (ie, >24 hours) may give false-positive results.

 

Twenty-four hour urinary free cortisol values may be elevated to twice the upper limit of the normal range during pregnancy.

 

Patients with exogenous Cushing syndrome caused by ingestion of hydrocortisone will not have suppressed cortisol values.

Supportive Data

In Mayo’s reference value study, gender was found to significantly influence cortisol values (P value = 0.001). However, while this was statistically significant, gender explained only 6% of the variability in cortisol normal ranges and, therefore, was not considered to have a clinically significant impact on cortisol reference values.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Findling JW, Raff H: Diagnosis and differential diagnosis of Cushing's syndrome. Endocrinol Metab Clin North Am 2001;30:729-747

2. Boscaro M, Barzon L, Fallo F, Sonino N: Cushing's syndrome. Lancet 2001;357:783-791

3. Taylor RL, Machacek D, Singh RJ: Validation of a high-throughput liquid chromatography-tandem mass spectrometry method for urinary cortisol and cortisone. Clin Chem 2002;48:1511-1519

Method Description Describes how the test is performed and provides a method-specific reference

Deuterated cortisol (d3-cortisol) is added to a 0.1-mL urine specimen as an internal standard. Cortisol, cortisone, and d3-cortisol are extracted from the specimens using online turbulent-flow high-performance liquid chromatography (HPLC) and analyzed by liquid chromatography-tandem mass spectrometry (LC/MS-MS) using multiple-reaction monitoring in positive mode. The following ion pairs are used for analysis: cortisol (363.0/121.1), cortisone (361.0/163.0), d3-cortisol (366.0/121.2). A calibration curve, generated from stripped urine spiked standards, is included with each batch of patient specimens.(Taylor RL, Machacek DA, Singh RJ: Validation of a high-throughput liquid chromatography-tandem mass spectrometry method for urinary cortisol and cortisone. Clin Chem 2002;48:1511-1519)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Friday, Sunday: 1 p.m.

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

2 days (not reported on Sundays)

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

5 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

82530

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
8546Cortisol, U14158-0
TM93Collection Duration13362-9
VL47Urine Volume19153-6