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Test Code ITCON Itraconazole, Serum

Reporting Name

Itraconazole, S

Useful For

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

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum Red


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

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 a plastic vial within 2 hours of collection.


Specimen Minimum Volume

0.18 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 29 days
  Ambient  29 days
  Frozen  29 days

Reference Values

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.

Day(s) Performed

Monday through Friday; Saturday

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80189

LOINC Code Information

Test ID Test Order Name Order LOINC Value
ITCON Itraconazole, S 10989-2

 

Result ID Test Result Name Result LOINC Value
81247 Itraconazole, S 10989-2
5122 Hydroxyitraconazole 18337-6

Interpretation

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.

Clinical Reference

1. Andes D, Pascual A, Marchetti O. Antifungal therapeutic drug monitoring: established and emerging indications. Antimicrob Agents Chemother. 2009;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;21(6):580-586. doi:10.1097/QCO.0b013e3283184611

3. Milone MC, Shaw LM. Therapeutic drugs and their management. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:420-453

Report Available

1 to 3 days

Method Name

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

Forms

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