Test ID: 17BFP
Fluticasone 17-Beta-Carboxylic Acid, Urine
Secondary ID 
A test code used for billing and in test definitions created prior to November 2011
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
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)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Aliases Lists additional common names for a test, as an aid in searching
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 needed for testing
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.
Collection Container/Tube: Clean, plastic urine collection container
Submission Container/Tube: Plastic, 10-mL urine tube (Supply T068)
Specimen Volume: 5 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative.
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.
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 Type | Temperature | Time |
|---|---|---|
| Urine | Frozen (preferred) | 14 days |
| Refrigerated | 72 hours | |
| Ambient | 24 hours |
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 Provides recommendations for further 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. 60 uL 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)
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.
Tuesday; 11 a.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.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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.
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.
83789
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 ID | Reporting Name | LOINC Code |
|---|---|---|
| 89739 | Fluticasone 17-B Carboxylic Acid, U | 46952-8 |
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