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Test Code TAKRO Tacrolimus, Blood

Additional Codes

ProGraf®

Reporting Name

Tacrolimus, B

Useful For

Monitoring whole blood tacrolimus concentration during therapy, particularly in individuals coadministered cytochrome P450 (CYP) 3A4 substrates, inhibitors, or inducers

 

Adjusting dose to optimize immunosuppression while minimizing toxicity

 

Evaluating patient compliance

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Specimen Type

Whole Blood EDTA


Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions:

1. Draw blood immediately before a schedule 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.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

Reference Values

5.0-15.0 ng/mL (Trough)

 

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.

Day(s) Performed

Monday through Sunday

CPT Code Information

80197

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TAKRO Tacrolimus, B 77348-1

 

Result ID Test Result Name Result LOINC Value
35145 Tacrolimus, B 77348-1

Test Classification

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.

Interpretation

Most individuals display optimal response to tacrolimus with trough whole blood levels of 5.0 to 15.0 ng/mL. Preferred therapeutic ranges may vary by transplant type, protocol, and comedications.

 

Therapeutic ranges are based on specimen collected at trough (ie, immediately before a scheduled dose). Higher results will be obtained when the blood is drawn at other times.

 

The 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 are approximately 30% less than by immunoassay.

Clinical Reference

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

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

3. Milone MC, Shaw LM: Therapeutic drugs and their management. In: Rifai N, Chiu RWK, Young I, Burnham CAD, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:420-453

Report Available

Same day/1 to 3 days

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Forms

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

-General Request (T239)

-Renal Diagnostics Test Request (T830)

-Therapeutics Test Request (T831)