Test Catalog

Test Id : EVROL

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Everolimus, Blood

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Overview

Test Catalog

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

Managing everolimus immunosuppression in solid organ transplant

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

Everolimus, B

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

Afinitor

Evero

Zortress

Specimen Type
Describes the specimen type validated for testing

Whole Blood EDTA

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

Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose.

2. Do not centrifuge.

3. Send whole blood specimen in original tube. Do not aliquot.

Additional Information: Therapeutic range applies to trough specimens collected immediately prior to a.m. dose.

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Renal Diagnostics Test Request (T830)

-Therapeutics Test Request (T831)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

1 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
Clotted specimens Reject

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
Whole Blood EDTA Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 14 days

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

Managing everolimus immunosuppression in solid organ transplant

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

Everolimus is an immunosuppressive agent derived from sirolimus (rapamycin). Both drugs function via inhibition of mTOR (mechanistic target of rapamycin) signaling and share similar pharmacokinetic and toxicity profiles. Everolimus has a shorter half-life than sirolimus, which allows for more rapid achievement of steady-state pharmacokinetics. Everolimus is extensively metabolized, primarily by cytochrome P450 (CYP) 3A4, thus its use with inducers or inhibitors of that enzyme may require dose adjustment. The most common adverse effects include hyperlipidemia, thrombocytopenia, and nephrotoxicity. Everolimus is useful as adjuvant therapy in renal cell carcinoma and other cancers. It recently gained US Food and Drug Administration approval for prophylaxis of graft rejection in solid organ transplant, an application that has been accepted for years in Europe. The utility of therapeutic drug monitoring has not been established for everolimus as an oncology chemotherapy agent; however, measuring blood drug concentrations is common practice for its use in transplant. Therapeutic targets vary depending on the transplant site and institution protocol. Guidelines for heart and kidney transplants suggest that trough (immediately prior to the next scheduled dose) blood concentrations between 3 and 8 ng/mL provide optimal outcomes.

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.

3-8 ng/mL

 

Target steady-state trough concentrations vary depending on the type of transplant, concomitant immunosuppression, clinical/institutional protocols, and time post-transplant. Results should be interpreted in conjunction with this clinical information and any physical signs/symptoms of rejection/toxicity.

Interpretation
Provides information to assist in interpretation of the test results

Therapeutic targets vary by transplant site and institution protocol. Heart and kidney transplant guidelines suggest a therapeutic range of 3 to 8 ng/mL.

 

Measurement of drug concentrations in oncology chemotherapy is less common, thus no therapeutic range is established for this application.

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

Therapeutic targets vary by transplant site and institution protocol. Established ranges refer to trough (predose) concentrations.

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

1. Eisen HJ, Tuzcu EM, Dorent R, et al: Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003;349(9):847-858

2. Kovarik JM, Beyer D, Schmouder RL: Everolimus drug interactions: application of a classification system for clinical decision making. Biopharm Drug Dispos. 2006;27(9):421-426

3. Rothenburger M, Zuckermann A, Bara C, et al: Recommendations for the use of everolimus (Certican) in heart transplantation: results from the second German-Austrian Certican Consensus Conference. J Heart Lung Transplant. 2007;26(4):305-311

4. Sanchez-Fructuoso AI: Everolimus: an update on the mechanism of action, pharmacokinetics and recent clinical trials. Expert Opin Drug Metab Toxicol. 2008;4(6):807-819

5. Milone MC, Shaw LM: Therapeutic drugs and their management. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:800-831

6.van Gelder T, Fischer L, Shihab F, Shipkova M: Optimizing everolimus exposure when combined with calcineurin inhibitors in solid organ transplantation. Transplant Rev (Orlando). 2017;31(3):151-157. doi:10.1016/j.trre.2017.02.007

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

Whole blood samples are mixed with methanolic zinc sulfate to lyse blood cells. The supernatant is removed and analyzed by liquid chromatography-tandem mass spectrometry.(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 Sunday

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.

Same day/1 to 2 days

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

14 days

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 account representative. 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. It 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.

80169

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
EVROL Everolimus, B 50544-6
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.
35146 Everolimus, B 50544-6

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