Ordering Recommendation
Optimize drug therapy and monitor patient adherence.
Mnemonic
Methodology
Quantitative Liquid Chromatography-Tandem Mass Spectrometry
Performed
Sun-Sat
Reported
Within 24 hours
New York DOH Approval Status
Specimen Required
Pre-dose (trough) levels should be drawn.
Lavender (EDTA) or pink (K2EDTA).
Transport 1 mL whole blood. (Min: 0.25 mL)
Refrigerated.
Serum or plasma. Specimens left at room temperature for longer than 24 hours. Clotted specimens.
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.
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
CPT Codes
80197
Components
Component Test Code* | Component Chart Name | LOINC |
---|---|---|
0090612 | Tacrolimus by HPLC-MS/MS | 11253-2 |
Aliases
- FK506
- Prograf
- Prograf{R} (Tacrolimus by Tandem Mass Spectrometry)
- Protopic