Ordering Recommendation

Optimize drug therapy and monitor patient adherence.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation

Timing of specimen collection: Pre-dose (trough) draw - At steady state concentration.

Collect

Plain Red, Lavender (EDTA), or Green (Sodium or Lithium Heparin).

Specimen Preparation

Separate from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.6 mL)

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Whole blood. Gel separator tubes, Light Blue (citrate), or Yellow (SPS or ACD solution).

Remarks
Stability

After separation from cells: Ambient: 48 hours; Refrigerated: 48 hours; Frozen: 6 months

Methodology

Quantitative High Performance Liquid Chromatography-Tandem Mass Spectrometry

Performed

Tue, Thu, Sat

Reported

1-6 days

Reference Interval

Effective August 15, 2011

Therapeutic Ranges
Itraconazole (trough) - Localized Infection Greater than 0.5 µg/mL
Itraconazole (trough) - Systemic Infection Greater than 1.0 µg/mL
Hydroxyitraconazole No therapeutic range established

Interpretive Data

Itraconazole is an azole antifungal drug indicated to treat fungal infections. The therapeutic range is based on serum, predose (trough) draw collection at steady-state concentration. The pharmacokinetics of itraconazole are influenced by drug-drug interactions when coadministered with drugs metabolized by cytochrome P450 3A4 enzyme. Itraconazole and hydroxyitraconazole concentrations combined should not exceed 10 µg/mL. Adverse effects may include nausea, abdominal pain, and congestive heart failure.

Compliance Category

Laboratory Developed Test (LDT)

Note

Hotline History

N/A

CPT Codes

80189

Components

Component Test Code* Component Chart Name LOINC
0098517 Itraconazole, Quantitative by LC-MS/MS 10989-2
0098518 Hydroxyitraconazole, Quantitative 18337-6
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • Antifungal Serum Level
  • itranconazole blood level
  • Sporanox
  • sporanox blood concentration
  • Sporanox blood level
Itraconazole, Quantitative by LC-MS/MS