Itraconazole Level (including Hydroxyitraconazole)

Sporanox, Sporaz, Orungal, Itraconazole Level

Test Codes

EPIC: LAB1231313, Beaker: ITRAC

Department

Toxicology

Specimen Collection Criteria

Collect: One plain Red-top tube.

Do not use Serum Separator Tubes.
Time of Collection: Trough, just prior to the next dose.

Physician Office/Draw Specimen Preparation

Do not centrifuge. Maintain whole blood in original collection tube at room temperature (20-26°C or 68-78.8°F) prior to transport.

Preparation for Courier Transport

Transport: Whole blood in original collection tube at room temperature (20-26°C or 68-78.8°F). (Minimum: 2.0 mL)

Rejection Criteria

Serum Separator (SST) tubes.  

In-Lab Processing

Let specimen clot 30-60 minutes then centrifuge to separate serum from cells. Transfer serum to a plastic transport tube and refrigerate (2-8°C or 36-46°F).

Transport: 1.0 mL serum, refrigerated (2-8°C or 36-46°F). (Minimum: 0.18 mL)

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 2 hours
Refrigerated (2-8°C or 36-46°F): 7 days
Frozen (-20°C/-4°F or below): 3 months

Specimen Storage in Department Prior to Disposal:

Refrigerated (2-8°C or 36-46°F): 3 days
Frozen (-20°C/-4°F or below): 3 months

Laboratory

Royal Oak Send Outs Laboratory

Performed

Sunday – Saturday.
Results available within 24 hours.

Reference Range

≥ 0.7 mcg/mL (localized infections)

≥ 1.0 mcg/mL (systemic infections)

Test Methodology

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

This test was developed, and its performance characteristics determined by Beaumont Health. It has not been cleared or approved by the FDA. The Laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes and should not be regarded as investigational or for research.

Clinical Utility

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 is approximately 55% but is highly variable; absorption can be enhanced by food or acidic drinks. Hepatic enzyme inducers can cause low serum itraconazole levels, and co-administration of these drugs has been associated with itraconazole therapeutic failure.

The test is indicated in patients with life-threatening fungal infections and in patients considered at risk for poor absorption or rapid clearance of itraconazole.

CPT Codes

80189

Contacts

Last Updated

3/6/2025