Test Catalog

Test Id : SIIRO

Sirolimus, Whole Blood

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Method Name
A short description of the method used to perform the test

High-Performance Liquid Chromatography-Tandem Mass Spectrometry (HPLC-MS/MS)

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Sirolimus, B

Aliases
Lists additional common names for a test, as an aid in searching

Rapamune

Rapamycin

Specimen Type
Describes the specimen type validated for testing

Whole Blood EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

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)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Sirolimus is a macrolide antibiotic, isolated from Streptomyces hygroscopicus, with potent effects including suppression of T- and B-cell proliferation and antineoplastic and antifungal activity. It inhibits the protein kinase mTOR to arrest the cell cycle; it has no effects on calcineurin and, therefore, can be used in addition to cyclosporine or tacrolimus, or as a substitute in patients intolerant to these drugs. Sirolimus is metabolized by cytochrome P450 (CYP) 3A4; thus, blood concentrations are affected by drugs that inhibit or induce this enzyme. The pharmacokinetic interaction between sirolimus and cyclosporine or tacrolimus increases both therapeutic immunosuppression and the toxicity of these agents; lower doses are required with combined use. Adverse effects of sirolimus are generally concentration dependent, making therapeutic drug monitoring essential.

 

The frequency of monitoring trough concentrations varies on the indication. For example for kidney transplant recipients, sirolimus is commonly measured at least 3 to 4 days after a loading dose or if the kidney transplant recipient is receiving cyclosporin between 5 to 7 days after initiation. Target concentrations vary depending on concomitant therapy, time posttransplant, the desired degree of immunosuppression, and adverse effects. When given with cyclosporine or tacrolimus, the therapeutic range for sirolimus is generally between 4 and 12 ng/mL with minimal added benefit for concentrations >10 ng/mL. When sirolimus is given without calcineurin inhibitors, higher trough levels are needed, usually 12 to 20 ng/mL, but occasionally up to 20 to 30 ng/mL.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

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.

Interpretation
Provides information to assist in interpretation of the test results

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 drawn 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 liquid chromatography-tandem mass spectrometry are approximately 30% less than by immunoassay.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The recommended therapeutic range applies to trough specimens collected immediately before a dose. Blood drawn at other times will yield higher results.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

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;1:8-18

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 Apr 15;67(7):1036-1042

Method Description
Describes how the test is performed and provides a method-specific reference

Blood specimens are subjected to protein precipitation. The resulting supernatant is analyzed by liquid chromatography-tandem mass spectrometry.(Pablo AH, Breaud AR, Clarke W. Analysis of immunosuppressant drugs in whole blood by liquid chromatography-tandem mass spectrometry (LC-MS/MS)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

Same day/1 to 3 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their Regional Manager. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test was developed, and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80195

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
SIIRO Sirolimus, B 29247-4
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
35144 Sirolimus, B 29247-4

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports