Sirolimus by Tandem Mass Spectrometry

0098467
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High
Normal
Ordering Recommendation

Optimize drug therapy and monitor patient adherence.

Mnemonic
RAPAMUNE
Methodology

Quantitative High Performance 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: 1 week; Frozen: 2 months

Reference Interval

Effective February 18, 2014

Therapeutic Range:
Kidney transplant (in combination with Cyclosporine): 4-12 ng/mL
Toxic value: Greater than 25 ng/mL

Interpretive Data

A range of 12-20 ng/mL has been suggested for liver transplant. 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.  

Compliance Statement B: For laboratory developed tests not using a RUO kit, and for FDA approved, cleared or 510(k) exempt assays with alterations. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.

Note

Sirolimus (Rapamune) whole blood concentrations can be measured by either chromatographic or immunoassay methodologies. These two methodologies are not directly interchangeable and the measured sirolimus 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 sirolimus metabolites.

Hotline History
N/A
CPT Codes

80195

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Components
Component Test Code* Component Chart Name LOINC
0098467 Sirolimus by HPLC-MS/MS 29247-4
* 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
  • Rapamune
  • Rapamycin
Sirolimus by Tandem Mass Spectrometry