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Itraconazole LC-MS/MS

Test Code: 2800

Cpt Code:

80299 (x1)

Clinical Utility

Patient variability in the pharmacokinetics of itraconazole supports quantitative monitoring of blood drug levels, particularly due to its variable absorption. Monitoring trough levels of intraconazole and hydroxyitraconazole (the metabolite of intraconazole) is suggested in the first 1 - 2 weeks of treatment to ensure therapeutic levels have been achieved. Results may be clinically useful to determine if current dosing levels require adjustment for ongoing treatment.

Procedure

Itraconazole/hydroxyitraconazole are extracted from biological matrix by simple protein precipitation with methanol followed by centrifugation. Chromatographic separation and quantitative analysis of the drug containing supernatant is performed using reversed-phase UPLC-MS/MS method. This test has not been cleared or approved for diagnostic use by the U.S. Food and Drug Administration.

Assay Range

0.1 to 10 mcg/mL.

Causes For Rejection

Specimens received not frozen, whole blood collected in serum or plasma gel, serum gel tubes, or specimen types other than those listed are not accepted.

Turnaround Time

Same day as specimen receipt. Monday through Saturday.

Shipping

Ship Monday through Friday. Friday shipments must be labeled for Saturday delivery. All specimens must be labeled with patient's name and collection date. A Viracor-IBT test requisition form must accompany each specimen. Multiple tests can be run on one specimen. Ship specimens FedEx Priority Overnight® to: Viracor-IBT Laboratories, 1001 NW Technology Dr, Lee's Summit, MO 64086.

Specimen Information

2801 plasma

NY approved. Collect 4-5 mL whole blood in EDTA tube (ACD and Sodium Heparin tubes are not acceptable), and plasma separated by centrifugation within 30 minutes of the draw time and transfer 1 mL plasma to a, screw top tube. Do NOT draw in a gel tube. Ship frozen in dry ice Monday through Friday.

2810 serum

NY approved. Collect 4-5 mL whole blood in red-top tube, allowed to clot for 30 to 60 minutes and centrifuged to isolate the serum and transfer 1 mL to, screw top tube. Do NOT draw in a gel tube. Ship frozen in dry ice Monday through Friday.

Disclaimer

Specimens are approved for testing in New York only when indicated in the Specimen Information field above.

The CPT codes provided are based on Viracor-IBT's interpretation of the American Medical Association's Current Procedural Terminology (CPT) codes and are provided for general informational purposes only. CPT coding is the sole responsibility of the billing party. Questions regarding coding should be addressed to your local Medicare carrier. Viracor-IBT assumes no responsibility for billing errors due to reliance on the CPT codes illustrated in this material.

References

Ashbee HR, Barnes RA, Johnson EM, et al. Therapeutic drug monitoring (TDM) of antifungal agents: guidelines from the British Society for Medical Mycology. J Antimicrob Chemother 2014; 69: 1162-76.

Glasmacher A, Hahn C, Leutner C, et al. Breakthrough invasive fungal infections in neutropenic patients after prophylaxis with itraconazole. Mycoses 1999; 42: 443-51.

Cartledge JD, Midgely J, Gazzard BG. Itraconazole solution: higher serum drug concentrations and better clinical response rates than the capsule formulation in acquired immunodeficiency syndrome patients with candidosis. J Clin Pathol 1997; 50: 477-80.

 

 

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