Tacrolimus by Tandem Mass Spectrometry

0090612
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Therapeutic

Ordering Recommendation

Optimize drug therapy and monitor patient adherence.

Mnemonic

TACRO

Methodology

Quantitative Liquid Chromatography-Tandem Mass Spectrometry

Performed

Sun-Sat

Reported

Within 24 hours

New York DOH Approval Status

This test is New York DOH approved.

Specimen Required

Patient Preparation

Pre-dose (trough) levels should be drawn.

Collect

Lavender (EDTA) or pink (K2EDTA).

Specimen Preparation

Transport 1 mL whole blood. (Min: 0.25 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Serum or plasma. Specimens left at room temperature for longer than 24 hours. Clotted specimens.

Remarks
Stability

Ambient: 24 hours; Refrigerated: 2 weeks; Frozen: 2 months

Reference Interval

Effective February 18, 2014

Therapeutic Range:
Kidney transplant: 0-3 months post-transplant: 7.0-20.0 ng/mL
3 months and older: 5.0-15.0 ng/mL
Heart transplant: 0-3 months post-transplant: 10.0-20.0 ng/mL
3 months and older: 5.0-15.0 ng/mL
Liver transplant: 1-12 months post-transplant: 5-20 ng/mL
Toxic value: Greater than 25 ng/mL

Interpretive Data

Therapeutic range is based on a whole blood specimen drawn 12 hours post-dose or prior to next dose (the trough). The optimal therapeutic range for a given patient may differ from this suggested range based on the indication for therapy, treatment phase (initiation or maintenance), use in combination with other drugs, time of specimen collection relative to prior dose, type of transplanted organ, and/or the therapeutic approach of the transplant center.

This test was developed and its performance characteristics determined by ARUP Laboratories. It has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes.

Compliance Category

Laboratory Developed Test (LDT)

Note

Tacrolimus (Prograf) whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable, and the measured tacrolimus whole blood concentration depends on the methodology used. Reference ranges may vary according to the specific immunoassay or HPLC-MS/MS test. Generally, immunoassays have been reported to have a positive bias relative to HPLC-MS/MS assays due to the detection of antibody cross-reactivity with tacrolimus metabolites. 

Hotline History

N/A

CPT Codes

80197

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Components

Component Test Code* Component Chart Name LOINC
0090612 Tacrolimus by HPLC-MS/MS 11253-2
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • FK506
  • Prograf
  • Prograf{R} (Tacrolimus by Tandem Mass Spectrometry)
  • Protopic
Tacrolimus by Tandem Mass Spectrometry