Test Code SIIRO Sirolimus, Whole Blood
Reporting Name
Sirolimus, BUseful For
Monitoring whole blood sirolimus 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 RochesterSpecimen Type
Whole Blood EDTASpecimen Required
Container/Tube: Lavender top (EDTA)
Specimen Volume: 3 mL
Collection Instructions:
1. Draw blood immediately before a scheduled dose.
2. Do not centrifuge.
3. Send whole blood specimen in original tube. Do not aliquot.
Additional Information: Therapeutic range applies to trough specimen 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) | 28 days | |
Ambient | 28 days | ||
Frozen | 28 days |
Reference Values
4-20 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
80195
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
SIIRO | Sirolimus, B | 29247-4 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
35144 | Sirolimus, B | 29247-4 |
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 sirolimus with trough whole blood levels 4 to 20 ng/mL. Preferred therapeutic ranges may vary by transplant type, protocol, and comedications.
Therapeutic ranges are based on specimens collected at trough (ie, immediately before a scheduled dose). Higher results will be obtained when the blood is collected at other times.
The assay is specific for sirolimus; it does not cross-react with cyclosporine, cyclosporine metabolites, tacrolimus, tacrolimus metabolites, or sirolimus metabolites. Results by liquid chromatography with detection by tandem mass spectrometry are approximately 30% less than by immunoassay.
Clinical Reference
1. 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
2. Kahan BD. Ten years of mTOR inhibitor therapy. Transplant Proc. 2003;35(3A):3S-240S
3. Yakupoglu YK, Kahan BD. Sirolimus: a current perspective. Exp Clin Transplant 2003;1(1):8-18
4. Groth CG, Backman L, Morales JM, et al. Sirolimus (rapamycin)-based therapy in human renal transplantation: similar efficacy and different toxicity compared with cyclosporine. Sirolimus European Renal Transplant Study Group. Transplantation. 1999;67(7):1036-1042
Report Available
Same day/1 to 3 daysMethod 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:
-Renal Diagnostics Test Request (T830)
-Therapeutics Test Request (T831)