Test Catalog

Test Id : FIVCZ

Isavuconazole (CRESEMBA) LC-MS/MS

Method Name
A short description of the method used to perform the test

Reversed-phase UPLC-MS/MS

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Isavuconazole

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Specimen Type: Serum

Container/Tube: Red

Specimen Volume: 1 mL

Collection Instructions: Draw blood in a plain red-top tube(s), serum gel tube is not acceptable. Spin down and send 1 mL of serum Frozen in a sterile, screw top tube.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis: Mild OK; Gross Reject
Thawing: Warm Reject; Cold OK
Gross lipemia: Reject
Gross icterus: NA
Other: NA

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Serum Frozen (preferred) 14 days
Ambient 5 days
Refrigerated 5 days

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Isavuconazole is for the treatment of life threatening fungal infections, specifically invasive aspergillosis and invasive mucormycosis. There is a significant need for alternative antifungal therapies that address some of the limitations of voriconazole, such as reduced potential for nephrotoxicity for the intravenous formulation, in addition to other dose-related toxicities. Given the difficulty in diagnosis and similarity with which infections may present, having an antifungal that is effective for both indications would be particularly useful to physicians treating immunocompromised patients.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

0.1-10. mcg/mL

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Astellas Pharma US, Inc., CRESEMBA Package Insert.

2. von Mach MA1, Burhenne J, Weilemann LS. 2006. Accumulation of the solvent vehicle sulphobutylether beta cyclodextrin sodium in critically ill patients treated with intravenous voriconazole under renal replacement therapy. BMC Clin Pharmacol. 2006 6:6.

3. Pascual A1, Calandra T, Bolay S, Buclin T, Bille J, Marchetti O. 2008. Voriconazole therapeutic drug monitoring in patients with invasive mycoses improves efficacy and safety outcomes. Clin Infect Dis. 46(2):201-11.

4. Andes D, Pascual A, Marchetti O. Antifungal Therapeutic Drug Monitoring: Established and Emerging Indications. Antimicrob Agents Chemother. 2009 Jan; 53(1):24–34.

5. Goodwin ML, Drew RH. Antifungal serum concentration monitoring: an update. J Antimicrob Chemother. 2008 Jan; 61(1):17–25.

6. Pappas PG1, Kauffman CA, Andes D, et al. Clinical practice guidelines for the management of candidiasis: 2009 update by the Infectious Diseases Society of America. Clin Infect Dis. 2009 Mar 1; 48(5):503-35.

7. Walsh TJ1, Anaissie EJ, Denning DW, et al. Treatment of aspergillosis: clinical practice guidelines of the Infectious Diseases Society of America. Clin Infect Dis. 2008 Feb 1; 46(3):326-60.

Method Description
Describes how the test is performed and provides a method-specific reference

Isavuconazole is extracted by protein precipitation with methanol followed by centrifugation. Chromatographic separation and quantitative analysis of the supernatant are performed using reversed-phase UPLC-MS/MS.

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Eurofins Viracor

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed and its performance characteristics determined by Viracor Eurofins. It has not been cleared or approved by the U.S. Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80299

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
FIVCZ Isavuconazole Not Provided
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
FIVCZ Isavuconazole Not Provided

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports