Test Catalog

Test Id : POSA

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Posaconazole, Serum

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring posaconazole therapy

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

Liquid Chromatography-Tandem Mass Spectrometry (LC-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

Posaconazole, S

Aliases
Lists additional common names for a test, as an aid in searching

Noxafil (Posaconazole)

Posaconazole (Noxafil)

Specimen Type
Describes the specimen type validated for testing

Serum Red

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

Collection Container/Tube: Red top (serum gel/SST are 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.

Forms

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

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

0.6 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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 Red Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring posaconazole therapy

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

Posaconazole interferes with fungal cytochrome P450 (CYP) lanosterol-14 alpha demethylase activity, thereby decreasing synthesis of ergosterol, the principal sterol in fungal cell membrane, and inhibiting fungal cell membrane formation.(1,2)

 

Posaconazole has been approved for prophylaxis of invasive Aspergillus and Candida infections in severely immunocompromised patients (eg, hematopoietic stem cell transplant recipients with graft-versus-host disease [GVHD] or those with prolonged neutropenia secondary to chemotherapy for hematologic malignancies) and treatment of oropharyngeal candidiasis (including patients refractory to itraconazole or fluconazole).(1,3) It also is approved for ocular administration (drug monitoring not required for this use).

 

Posaconazole has a variable absorption. Food and liquid nutritional supplements increase absorption, and fasting states do not provide sufficient absorption to ensure adequate plasma concentrations.(4,5) The drug has a high volume of distribution (Vd=465-1774 L) and is highly protein bound (> or =97%), predominantly to albumin.(1,3) The drug does not undergo significant metabolism; approximately 15% to 17% undergoes non-CYP-mediated metabolism, primarily via hepatic glucuronidation into metabolites.(1) The half-life elimination is approximately 35 hours (range: 20-66 hours); steady state is achieved after about 5 to 7 days. Time to maximum concentration is approximately 3 to 5 hours, but due to the highly variable absorption, trough level monitoring is recommended.

 

Therapeutic drug monitoring should be considered in the following situations:

-To document optimal absorption when used for prophylaxis or active treatment of a fungal infection

-Consider rechecking a level even if initial level was in the goal range, if the patient:

-Is unable to meet optimal nutritional intake

-Is receiving continuous tube feeding

-Is receiving a proton pump inhibitor (decreased posaconazole levels in some studies)

-Has mucositis, diarrhea, vomiting, GVHD, or other reason that the drug may not be absorbed well

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.

>700 ng/mL (trough)

Interpretation
Provides information to assist in interpretation of the test results

Levels greater than 700 ng/mL (0.7 mcg/mL) have been suggested for prophylaxis.

 

Levels greater than or equal to 1250 ng/mL (1.25 mcg/mL) were shown to be optimal in a salvage trial for treatment of invasive Aspergillus infections.

 

Toxic range has not been established.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

No significant cautionary statements

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

1. Noxafil (posaconazole). Package insert: Schering Corporation; 2006

2. Goodman and Gilman's: The Pharmacological Basis of Therapeutics. 10th ed. McGraw-Hill Professional; 2001

3. Physicians' Desk Reference (PDR). 61st ed. Thomson PDR; 2007

4. Courtney R, Wexler D, Radwanski E, Lim J, Laughlin M: Effect of food on the relative bioavailability of two oral formulations of posaconazole in healthy adults. Br J Clin Pharmacol. 2004 Feb;57(2):218-222. doi: 10.1046/j.1365-2125.2003.01977.x

5. Courtney R, Radwanski E, Lim J, Laughlin M: Pharmacokinetics of posaconazole coadministered with antacid in fasting or nonfasting healthy men. Antimicrob Agents Chemother. 2004 Mar;48(3):804-808. doi: 10.1128/AAC.48.3.804-808.2004

6. Rifai N, Horvath AR, Wittwer CT, eds: Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018

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

Posaconazole is extracted by mixing serum samples with acetonitrile to precipitate proteins. The supernatant is removed and analyzed by a liquid chromatography-tandem mass spectrometry method.(Unpublished Mayo method)

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

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Saturday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

2 to 5 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

2 weeks

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

Rochester

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 Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US 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.

80187

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
POSA Posaconazole, S 53731-6
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.
89591 Posaconazole, S 53731-6

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