CLINICAL SERVICES

To Send Samples

REQUISITION – Fungus Testing Laboratory requisitions are required. If your laboratory does not have one, please call and one will be faxed to you. Please indicate all pertinent information such as patient’s name, requesting entity, address, contact, phone/fax numbers, etc. Also indicate on the requisition the dosage, patient’s date/time of last dose and date/time of sample drawn.

Testing Schedule

Bioassay: Set up Tuesday and Thursday with results reported on Wednesday and Friday

HPLC: Set up Monday – Friday depending on the test and workload.

Reports 24 hours following date of setup

Specimen Requirements

Sample Type:
Plasma or other biological fluids including CSF, bile, peritoneal fluid, dialysate or other biological fluids or tissues may be assayed for antifungal agents. Draw plasma samples using EDTA (lavender tubes).

SPECIAL HANDLING:
AMB-protect from light MICAFUNGIN – protect from light

SAMPLE AMOUNT:
1.0 ml of plasma or other fluid. Storage: Freeze until shipment. Shipment: Overnight on dry ice.

NOTES: VORI samples may be shipped on cold packs.

SHIPMENT:
Pack samples in proper container and ship for overnight delivery on dry ice. Please ship samples to arrive Monday through Friday, as the University is closed on Saturday and Sunday. Shipping fees are the responsibility of the sender.

RESULTS:
Turnaround times are typically 48- 72 hours from receipt of sample, depending on when the sample is received. Samples received on Friday may not be completed until Tuesday of the following week. All reports are mailed after completion. We will also phone or FAX the report if so instructed on the requisition.

There are no established therapeutic ranges for any of the antifungal agents.

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Fungus Testing Laboratory Services

Antifungal Drug Levels

The antifungal drug levels division of the Fungus Testing Laboratory has the capability to quantitatively assay the following antimycotic agents:

POSACONAZOLE (POS, HPLC) CPT 82491

    Posaconazole levels are assayed by high performance liquid chromatography (HPLC). The testing range for posaconazole is from 0.125 – 5.0 µg/ml. There are no established therapeutic ranges. The assay has been validated for plasma levels; however, the drug may be measured in CSF and other biological fluids.

    SAMPLE AMOUNT – Send approximately 0.5 - 1.0 ml of sample.

MICAFUNGIN (MICA, HPLC) CPT 82491

    Micafungin levels are assayed by high performance liquid chromatography (HPLC) with fluorescence detection. The testing range for micafungin is 0.05 – 25 µg/ml. The assay has been validated for plasma levels; however, the drug may be measured in CSF and other biological fluids.

    SAMPLE AMOUNT – Send approximately 0.5 ml of sample. See Specimen Requirements – (Protect from Light)

CASPOFUNGIN – (CASPO, HPLC) CPT 82491

    Caspofungin levels are assayed by high-performance liquid chromatography (HPLC) with fluorescence detection. The testing range is 0.2 – 10 µg/ml. The lowest limit of quantitation (LOQ) for caspofungin is 0.15 µg/ml. Plasma, urine and other body fluids may be assayed for caspofungin levels, however only caspofungin in plasma has been validated for this laboratory.

ANIDULAFUNGIN – (ANID, HPLC) CPT 8249

    Anidulafungin levels are assayed by high-performance liquid chromatography (HPLC) with fluorescence detection. The testing range is 0.125 – 10 µg/ml. The lowest limit of quantitation (LOQ) for anidulafungin is 0.125 µg/ml. Plasma, urine and other body fluids may be assayed for anidulafungin levels, however only anidulafungin in plasma has been validated for this laboratory.

ITRACONAZOLE (ITRA) CPT 80299

    Bioassay
    The bioassay method is suitable for patients on single antifungal therapy. For clinical purposes, the bioassay may be sufficient to determine if the patient is adequately absorbing the drug. Itraconazole bioassay measures total antifungal effect/inhibition in the biological test medium. The testing range for this itraconazole assay is from 0.5 – 20.0 µg/ml. Zones of inhibition less than the lowest standard (0.5 µg/ml) are reported as less than 0.5 (<0.5 µg/ml). Samples with no visible zone of inhibition are reported as “none detected”. In this laboratory, the majority of clinical samples for itraconazole levels are done by bioassay; however, if an itraconazole level by HPLC is required/preferred, the lab would certainly accommodate the request of the ordering physician. Test methodology may be specified on the requisition. The laboratory should be advised of all antifungal agents the patient is currently taking. Itraconazole levels for patients on combination therapy (i.e. 5-FC) are assayed by HPLC.

    HPLC (high performance liquid chromatography) CPT 82491
    HPLC, an analytical method, is used to assay itraconazole levels for patients on combination therapy as well as for pharmacokinetic studies. The sensitivity range for HPLC is 0.01 – 5.0 µg/ml. The HPLC result is reported in terms of the parent drug, itraconazole, and also itraconazole’s largest metabolite, hydroxy itraconazole. It has been well documented that the two methods, bioassay and HPLC, do not correlate; hence, bioassay values are approximately 3 times higher due to the active metabolite. It is imperative to maintain consistency in terms of assay methodology for each patient. The assay requires 1.0 ml of sample. Collect blood samples in heparin or EDTA tubes (green or lavender tops) and send only the plasma. Store at -20° C.

FLUCONAZOLE (FLU, gas-liquid chromatography) CPT 82491

    All fluconazole assays (clinical and pharmacokinetic studies) are done by gas-liquid chromatography. Sensitivity range for fluconazole is 0.25 to 200 µg/ml. Serum samples will usually fall within the lower range (0.25 – 50 µg/ml); however, the fluconazole procedure is linear up to 200 µg/ml which will accommodate anticipated higher levels found in urine samples. Assays can also be done on CSF, bile, peritoneal fluid, dialysate, and other biological fluids.

AMPHOTERICIN – B (AMB, HPLC) CPT 82491

    Plasma amphotericin – B deoxycholate and/or liposomal preparations of AMB are assayed by HPLC. The HPLC testing range is 0.05 – 10.0 µg/ml. For plasma samples, collect blood in EDTA tubes (lavender tops). See Specimen Requirements – (Protect from Light)

VORICONAZOLE – (VORI, HPLC) CPT 82491

    Voriconazole levels are assayed by high performance liquid chromatography (HPLC). The testing range is 0.2 – 10 µg/ml. The lowest limit of quantitation (LOQ) for voriconazole is 0.2 µg/ml. Plasma, CSF, and other body fluids may be assayed for voriconazole levels, however only voriconazole in plasma has been validated for this laboratory.

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