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Test Code VORI Voriconazole, Serum

Reporting Name

Voriconazole, S

Useful For

Monitoring trough levels of voriconazole is suggested for:

-Individuals with reduced liver function

-Individuals with cytochrome P450 (CYP) 2C19 alterations associated with poor metabolic function

-Patients taking other medications that affect CYP2C19 activity

-Patients experiencing potential toxicity

 

Monitoring trough levels may be reasonable in patients who are not responding optimally or have drug interactions that may decrease voriconazole levels or to ensure adequate oral absorption

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Serum Red


Specimen Required


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

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions: Centrifuge and aliquot serum into plastic vial within 2 hours of collection.


Specimen Minimum Volume

0.6 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reference Values

1.0-5.5 mcg/mL

Trough level (ie, immediately before next dose) monitoring is recommended.

Day(s) Performed

Monday through Sunday

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

80285

LOINC Code Information

Test ID Test Order Name Order LOINC Value
VORI Voriconazole, S 38370-3

 

Result ID Test Result Name Result LOINC Value
88698 Voriconazole, S 38370-3

Clinical Information

Voriconazole (Vfend) is an antifungal agent approved for treatment of invasive aspergillosis and candidemia/candidiasis, as well as for salvage therapy for infections in patients refractory to, or intolerant of, other antifungal therapy. The drug inhibits the fungal enzyme 14a-sterol demethylase, a critical step in ergosterol biosynthesis.

 

Voriconazole is metabolized in the liver primarily by cytochrome P450 (CYP) 2C19 with CYP2C9 and CYP3A4 having limited roles. The primary metabolite is voriconazole N-oxide, which has no antifungal activity. Drug clearance is primarily dependent on hepatic metabolism. The pharmacokinetics of voriconazole is highly variable and nonlinear, which results in an increased dose leading to a greater than proportional increase in serum concentration.

 

The bioavailability of oral voriconazole is greater than 95%. Approximately 60% of the drug in serum is protein bound. Voriconazole has a volume of distribution of 4.6 L/kg. Most (80%) of the drug is excreted in the urine, exclusively as metabolites.

 

Adverse effects of voriconazole include visual disturbances, skin rashes, and elevated liver enzyme levels.

Interpretation

Trough levels above 6 mcg/mL (and especially >10 mcg/mL) have been associated with toxicity in several reports.

 

Trough levels below 1 mcg/mL have been associated with suboptimal response in several reports.

Method Description

The serum sample is diluted in an acetonitrile internal standard. The protein precipitate is centrifuged and a portion of the supernatant is diluted with mobile phase 1 for detection by a tandem mass spectrometer.(Unpublished Mayo method)

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
 

Method Name

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

Secondary ID

88698