Test Catalog

Test Id : TACPK

Tacrolimus, Peak, Blood

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

Assessment of postdosing (peak) blood tacrolimus concentrations

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

Tacrolimus, Peak, B

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

FK506

Prograf

Cyclosporine Peak

Specimen Type
Describes the specimen type validated for testing

Whole Blood EDTA

Necessary Information

Date of last dose, time of last dose, and dosage information are required.

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. Do not centrifuge.

2. Send specimen in original tube.

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

1 mL

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

Gross hemolysis OK
Gros 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
Whole Blood EDTA Refrigerated (preferred) 14 days
Ambient 14 days
Frozen 14 days

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

Assessment of postdosing (peak) blood tacrolimus concentrations

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

Tacrolimus (Prograf) is a macrolide antibiotic derived from the fungus Streptomyces tsukubaenesis. Like cyclosporine, tacrolimus inhibits calcineurin to suppress T cells. Tacrolimus is metabolized by CYP3A4; thus, its concentration is affected by drugs that inhibit (calcium channel blockers, antifungal agents, some antibiotics, grapefruit juice) or induce (anticonvulsants, rifampin) this enzyme. Tacrolimus has a narrow therapeutic range and adverse effects are common, particularly at high dose and concentrations, making therapeutic drug monitoring essential.

 

Since 90% of tacrolimus is in the cellular components of blood, especially erythrocytes, whole blood is the preferred specimen for analysis of trough concentrations. Target steady-state concentrations vary depending on clinical protocol, the presence or risk of rejection, time from transplant, type of allograft, concomitant immunosuppression, and side effects (mainly nephrotoxicity). Optimal trough blood concentrations are generally between 5.0 and 15.0 ng/mL. Higher levels are often sought immediately after transplant, but as organ function stabilizes at about 4 weeks from transplant, doses are generally reduced in solid organ transplant patients who are stable. Trough concentrations should be maintained below 20 ng/mL.

 

Optimal postdose sampling strategies and blood concentrations have not been well established for tacrolimus. A study of 54 liver transplant patients suggested that most individuals have tacrolimus blood concentrations ranging between 5.0 and 30.0 ng/mL in samples drawn 1 to 4 hours after dosing, although some patients showed slightly higher blood concentrations at 1-hour postdose.

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.

5.0-30.0 ng/mL

 

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

Interpretation
Provides information to assist in interpretation of the test results

This test measures postdose levels of tacrolimus. Established reference ranges reflect trough measurement, and are not applicable to samples drawn after dosing. No reference ranges or standard sampling protocols have been established for postdosing tacrolimus levels, but a limited study of liver transplant recipients suggests most patients will show postdose tacrolimus levels ranging from 5.0 to 30.0 ng/mL when drawn 1 to 4 hours after dosing. The narrow therapeutic window and high individual pharmacokinetic variability of tacrolimus make regulation of dose by blood concentrations essential. Since 90% of the drug is in the cellular components of blood, especially erythrocytes, whole blood, rather than plasma, concentrations are measured and correlate better with efficacy and toxicity.

 

This assay is specific for tacrolimus; it does not cross-react with cyclosporine, cyclosporine metabolites, sirolimus, sirolimus metabolites, or tacrolimus metabolites. Results by liquid chromatography with detection by tandem mass spectrometry (LC-MS/MS) are approximately 30% less than by immunoassay.

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

Established (trough) tacrolimus reference ranges do not apply to samples drawn after administration of a dose. Order TACRO / Tacrolimus, Blood, for trough samples.

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

1. Kahan BD, Keown P, Levy GA, et al: Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther 2002 March;24(3):330-350

2. Scott LJ, McKeage K, Keam SJ, et al: Tacrolimus: a further update of its use in the management of organ transplantation. Drugs 2003;63(12):1247-1297

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

Blood samples are subjected to protein precipitation. The resulting supernatant is analyzed by liquid chromatography-tandem mass spectrometry (LC-MS/MS).(Charlson JC, Moyer TP: Therapeutic drug monitoring. In Tietz Textbook of Clinical Chemistry. Fourth edition. Edited by CA Burtis, ER Ashwood, DE Bruns. New York, WB Saunders Company, 2004)

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

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.

80197

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