Test Catalog

Test Id : 17BFP

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Fluticasone 17-Beta-Carboxylic Acid, Random, Urine

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Overview

Test Catalog

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

Assessing compliance (recent exposure) to fluticasone propionate therapy

 

An aid in the evaluation of secondary adrenal insufficiency

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

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

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

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Fluticasone 17-B Carboxylic Acid, U

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

Cutivate 0.005% (Fluticasone Propionate)

Flonase (Fluticasone Propionate)

Flovent (Fluticasone Propionate)

Flovent (Rotadisk (Fluticasone Propionate)

Fluticasone Propionate (Cutivate 0.005%, Flonase, Flovent, Flovent Rotadisk)

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Collection Container/Tube: Clean, plastic urine collection container

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

Specimen Volume: 5 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.6 mL

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

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Urine Frozen (preferred) 14 days
Refrigerated 72 hours
Ambient 24 hours

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

Assessing compliance (recent exposure) to fluticasone propionate therapy

 

An aid in the evaluation of secondary adrenal insufficiency

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

Inhaled corticosteroids are the single most effective therapy for adult patients with asthma. Even low doses of inhaled corticosteroids have been shown to reduce mortality related to asthma. The September 2007 issue of Pediatrics reported that "Verification of (asthma) treatment adherence by objective measures remains necessary."(1) In this pediatric asthma adherence study, the 104 asthmatic children and their parents grossly overestimated their medication adherence. Over 1 of 3 responses reported full compliance to medications when no medications had been taken. Over 46% of individuals exaggerated their adherence by at least 25%. The authors concluded that "Under the best of conditions in this study, accuracy of self-report was insufficient to provide a stand-alone measure of adherence."(1,2)

 

Fluticasone propionate (FP) is an inhaled corticosteroid with anti-inflammatory and immunosuppressive properties commonly used for the treatment of asthma, airway inflammation, and allergic rhinitis. FP is typically well tolerated and has a low risk for adverse systemic effects when utilized at recommended therapeutic doses. However, noncompliance with recommended FP therapy may result in poorly controlled asthma or misinterpretation of the patient's therapeutic responsiveness. Patients with excessive exposure to FP may present with clinical features of Cushing syndrome, but with evidence of hypothalamus-pituitary-adrenal axis suppression, including suppressed cortisol levels. Conversely, a patient not administering the drug as recommended may have their therapeutic responsiveness interpreted, in error by the patient or clinician, as steroid-resistance.

 

FP has low oral bioavailability and high hepatic first-pass metabolism, which results in low plasma FP concentrations; any systemic levels are believed to occur through adsorption from the lungs. Native FP absorbed by the gastrointestinal tract (<1% total FP) is rapidly metabolized by cytochrome P450 isoform 3A4 to yield fluticasone 17-beta-carboxylic acid, its primary metabolic product.(3) Fluticasone 17-beta-carboxylic acid is pharmacologically inactive and has increased water solubility such that it is excreted in urine. Accordingly, fluticasone 17-beta-carboxylic acid is detected in urine in individuals recently exposed to inhaled FP therapy. Fluticasone 17-beta-carboxylic acid may be detected in urine as early as 16 to 24 hours following a patient's first administration of low dose (220 mcg) FP therapy. The window of detection for fluticasone 17-beta-carboxylic acid is 6 days following cessation of FP therapy.

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.

Negative

Cutoff concentration: 10 pg/mL

 

Values for normal patients not taking fluticasone propionate should be less than the cutoff concentration (detection limit).

Interpretation
Provides information to assist in interpretation of the test results

Elevated fluticasone 17-beta-carboxylic acid indicates recent exposure to fluticasone propionate (FP).

 

Fluticasone 17-beta carboxylic acid concentration <10 pg/mL indicates that the patient may not have administered inhaled FP therapy within the preceding 6 days. Validated concerns about suboptimal patient adherence to asthma controller medications should lead to patient and provider interactions to address potential compliance issues.

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

Patients using fluticasone propionate (FP) therapy concurrently with a CYP3A4 inhibitor (eg, indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, or telithromycin) may be at increased risk of adrenal insufficiency because of reduced FP metabolism to fluticasone 17-beta carboxylic acid, with increased levels of the corticosteroid FP and suppression of adrenal cortisol production.(4) In this situation, urine fluticasone 17-beta carboxylic acid concentrations may be below the limit of quantitation.  

 

The Endocrine Laboratory should be notified if a urine specimen from a patient receiving fluorometholone therapy is to be analyzed for fluticasone 17-beta-carboxylic acid because fluorometholone is used as an internal standard in this method. If the laboratory is not notified and a significant amount of fluorometholone is present in the urine, a false-negative result may be reported.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Pearce RE, Leeder JS, Kearns GL: Biotransformation of fluticasone: in vitro characterization. Drug Metab Dispos 2006;34:1035-1040

2. Paton J, Jardine E, McNeill E, et al: Adrenal responses to low dose synthetic ACTH (Synacthen) in children receiving high dose inhaled fluticasone. Arch Dis Child 2006;91:808-813

3. Callejas SL, Biddlecombe RA, Jones AE, et al: Determination of the glucocorticoid fluticasone propionate in plasma by automated solid-phase extraction and liquid chromatography-tandem mass spectrometry. J Chromatogr B Biomed Sci Appl 1998;718:243-250

4. Bender BG, Bartlett SJ, Rand CS, et al: Impact of interview mode on accuracy of child and parent report of adherence with asthma-controller medication. Pediatrics. 2007;120:e471-477

5. National Asthma Education and Prevention Program: Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138

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

Fluorometholone (4 ng/mL) internal standard is added to each calibrator, control, and urine sample. Fluticasone 17-beta-carboxylic acid is extracted from 1 mL of urine using an acid-based acetonitrile precipitation followed by methylene chloride liquid extraction of the supernatant. Following extraction, 60 mcL of the reconstituted sample extract is injected onto a high-performance liquid chromatography system and analyzed by tandem mass spectrometry. The mass spectrometer operates under the electrospray interface and is operated in the multiple-reaction monitoring positive mode. The calibration utilizes an 8-point calibration curve over a concentration range of 0 to 10,000 pg/mL.(Unpublished Mayo method)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

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

Wednesday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 8 days

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

2 weeks

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

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

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 instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) 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 US 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 Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports