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26551 Sirolimus, Blood

Sirolimus, Blood
Test Code: SIRO
Synonyms/Keywords

​​Rapamycin, Rapamune®

Test Components

​Quantitation of sirolimus level in whole blood

Useful For

​Monitoring whole blood sirolimus concentration during therapy.  May be especially useful for individuals also administered CYP3A4 substrates, inhibitors, or inducers.

Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​No
​Whole Blood 
​EDTA Lavender Top Tube (LTT)
​

​3 mL
​​1 mL
250 uL
Collection Processing Instructions

Collection Processing Instructions:

1. Draw blood immediately before a scheduled dose.

2. Do not centrifuge.

3. Send specimen in original tube.  Do not aliquot.  Aliquots will be rejected.

Acceptable Specimen Types

​Who​le Blood

Specimen Stability Information
Specimen TypeTemperatureTime

​Whole Blood EDTA
​Refrigerated (preferred)
​
28 days
​
Frozen​
Ambient​2 days​
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation

​Marshfield
​Monday through Friday (prior to 12 pm)
​1 day
​Ultra High Performance Liquid Chromatography-Tandem Mass Spectrometry
Test Information
Sirolimus is an immunosuppressant commonly used to weaken the body's immune system to prevent rejection of organ transplant. It is also used to treat lymphangioleiomyomatosis-LAM (lung disease).  Sirolimus has a relatively narrow therapeutic range, making drug monitoring necessary to ensure the efficacy of the treatment, and also minimize toxic side effects.
Reference Range Information
Performing LocationReference Range

​Marshfield
​5.0 - 15​.0 ng/mL (Trough)

The optimal therapeutic range may vary based on the type of transplanted organ, indication for therapy, treatment phase, time of sample collection relative to prior dose, clinical or institutional protocols and/or use with other drugs. Interpretation of results should be in conjunction with the above clinical information and any physical signs of rejection or toxicity.​
Interpretation

Trough (ie, sample drawn immediately before a scheduled dose) Sirolimus concentrations are generally measured every 5 days.  Blood drawn at other times will yield higher results

Most individuals display optimal response to sirolimus with trough whole blood levels 4.0 to 20.0 ng/mL. Preferred therapeutic ranges may vary by transplant type, protocol, and co-medications.  Target concentrations vary depending on concomitant therapy, time post-transplant, 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.

The assay is specific for sirolimus; it does not cross-react with tacrolimus, everolimus, cyclosporine, or any of their metabolites.

Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments

​80195
​​​​
Classification

​This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.

Synonyms/Keywords

​​Rapamycin, Rapamune®

Test Components

​Quantitation of sirolimus level in whole blood

Ordering Applications
Ordering ApplicationDescription

​Cerner
​Sirolimus, Blood (SIIRO)

If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
Fasting RequiredSpecimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​No
​Whole Blood 
​EDTA Lavender Top Tube (LTT)
​

​3 mL
​​1 mL
250 uL
Collection Processing

Collection Processing Instructions:

1. Draw blood immediately before a scheduled dose.

2. Do not centrifuge.

3. Send specimen in original tube.  Do not aliquot.  Aliquots will be rejected.

Acceptable Specimen Types

​Who​le Blood

Specimen Stability Information
Specimen TypeTemperatureTime

​Whole Blood EDTA
​Refrigerated (preferred)
​
28 days
​
Frozen​
Ambient​2 days​
Useful For

​Monitoring whole blood sirolimus concentration during therapy.  May be especially useful for individuals also administered CYP3A4 substrates, inhibitors, or inducers.

Test Components

​Quantitation of sirolimus level in whole blood

Reference Range Information
Performing LocationReference Range

​Marshfield
​5.0 - 15​.0 ng/mL (Trough)

The optimal therapeutic range may vary based on the type of transplanted organ, indication for therapy, treatment phase, time of sample collection relative to prior dose, clinical or institutional protocols and/or use with other drugs. Interpretation of results should be in conjunction with the above clinical information and any physical signs of rejection or toxicity.​
Interpretation

Trough (ie, sample drawn immediately before a scheduled dose) Sirolimus concentrations are generally measured every 5 days.  Blood drawn at other times will yield higher results

Most individuals display optimal response to sirolimus with trough whole blood levels 4.0 to 20.0 ng/mL. Preferred therapeutic ranges may vary by transplant type, protocol, and co-medications.  Target concentrations vary depending on concomitant therapy, time post-transplant, 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.

The assay is specific for sirolimus; it does not cross-react with tacrolimus, everolimus, cyclosporine, or any of their metabolites.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedAnalytical TimeMethodology/Instrumentation

​Marshfield
​Monday through Friday (prior to 12 pm)
​1 day
​Ultra High Performance Liquid Chromatography-Tandem Mass Spectrometry
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments

​80195
​​​​
Classification

​This test was developed and its performance characteristics determined by Marshfield Labs.  It has not been cleared or approved by the US Food and Drug Administration.  This test is used for clinical purposes.  It should not be regarded as investigational or for research.

For most current information refer to the Marshfield Laboratory online reference manual.