Test Catalog

Test Id : ITCON

Itraconazole, Serum

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

Verifying systemic absorption of orally administered itraconazole

 

Patients with life-threatening fungal infections

 

Patients considered at risk for poor absorption or rapid clearance of itraconazole

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

Itraconazole, S

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

Itraconazole, Antimicrobial Assay

Sporanox (Itraconazole)

Specimen Type
Describes the specimen type validated for testing

Serum Red

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

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

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

0.18 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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
Serum Red Refrigerated (preferred) 29 days
Ambient 29 days
Frozen 29 days

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

Verifying systemic absorption of orally administered itraconazole

 

Patients with life-threatening fungal infections

 

Patients considered at risk for poor absorption or rapid clearance of itraconazole

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

Itraconazole is a synthetic triazole antifungal drug approved for treatment and prophylaxis of a variety of fungal infections. Its activity results from inhibition of fungal synthesis of ergosterol, an integral component of fungal cell membranes.

 

Concerns about adequate absorption and drug interactions are some of the major indications for therapeutic drug monitoring. Mean oral bioavailability approximates 55% but is highly variable; absorption can be enhanced by food or acidic drinks. Hepatic enzyme inducers can cause low serum itraconazole levels, and coadministration of these drugs has been associated with itraconazole therapeutic failure.

 

Itraconazole therapeutic efficacy is greatest when serum concentrations exceed 0.5 mcg/mL for localized infections or 1.0 mcg/mL for systemic infections. An active metabolite, hydroxyitraconazole, is present in serum at roughly twice the level of the parent drug. These concentrations refer to analysis by high-performance liquid chromatography; quantitation by bioassay generates considerably higher apparent drug measurements due to reactivity with the active metabolite.

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.

ITRACONAZOLE (TROUGH):

>0.5 mcg/mL (localized infection)

>1 mcg/mL (systemic infection)

 

HYDROXYITRACONAZOLE:

No therapeutic range established; activity and serum concentration are similar to parent drug.

Interpretation
Provides information to assist in interpretation of the test results

A lower cutoff concentration has not been defined that applies in all cases. The serum concentration must be interpreted in association with other variables, such as the nature of the infection, the specific microorganism, and minimal inhibitory concentration results, if available. Localized infections are more likely to respond when serum itraconazole is more than 0.5 mcg/mL (by high-performance liquid chromatography); systemic infections generally require drug concentrations more than 1.0 mcg/mL. Consider target of more than 1.5 mcg/mL for itraconazole plus hydroxyitraconazole. Therapeutic drug monitoring should be done at steady state, which usually occurs in about 7 days. Timing of the serum collection is not as critical due to the drug's long half-life, but trough collections are recommended.

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

Enteropathy, H2-histamine receptor blockers, hepatic enzyme inducers, and other variables can result in low to non-detectable serum levels with concomitant high risk of therapeutic failure.

 

Patients with AIDS and organ transplant recipients receiving immunosuppressive therapy tend to have lower serum itraconazole levels on standard doses and are thus at high risk of therapeutic failure.

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

1. Andes D, Pascual A, Marchetti O: Antifungal therapeutic drug monitoring: established and emerging indications. Antimicrob Agents Chemother. 2009 Jan;53(1):24-34. doi: 10.1128/AAC.00705-08

2. Hope WW, Billaud EM, Lestner J, Denning DW: Therapeutic drug monitoring for triazoles. Curr Opin Infect Dis. 2008 Dec;21(6):580-586. doi: 10.1097/QCO.0b013e3283184611

3. Rifai N, Horvath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

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

Itraconazole and hydroxyitraconazole are extracted by mixing serum samples with acetonitrile to precipitate proteins. The supernatant is removed and analyzed by an in-house developed liquid chromatography-tandem mass spectrometry method.(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.

Monday through Saturday

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.

1 to 3 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.

80189

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
ITCON Itraconazole, S 10989-2
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
81247 Itraconazole, S 10989-2
5122 Hydroxyitraconazole 18337-6

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