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Test Code MISC2MAYOCYCPK Cyclosporine, Peak, Blood

Secondary ID

42427

Useful For

Monitoring whole blood peak cyclosporine 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

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Cyclosporine, Peak, B

Specimen Type

Whole Blood EDTA


Ordering Guidance


This test is for specimens collected during a peak period. For specimens collected at trough, order CYCSP / Cyclosporine, Blood.



Necessary Information


Date of last dose, time of last dose, and dosage information are required.



Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 3 mL

Collection Instructions:

1. Do not centrifuge.

2. Send whole blood specimen in original tube. Do not aliquot.

Additional Information: No definitive therapeutic or toxic ranges have been established for this peak testing.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Whole Blood EDTA Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Clotted specimen Reject

Clinical Information

Cyclosporine is a lipophilic polypeptide used to prevent rejection after solid organ transplantation; it suppresses T-cell activation by inhibiting calcineurin to decrease interleukin-2 (IL-2) production. There is substantial interpatient variability in absorption, half-life, and other pharmacokinetic parameters. Cyclosporine is extensively metabolized by cytochrome P450 (CYP) 3A4 to at least 30 less-active metabolites, many of which are detected by immunoassays. Cyclosporine is known for many drug interactions, including increased neuro- and nephrotoxicity when coadministered with antibiotics, antifungals, or other immunosuppressants. Cyclosporine has a narrow therapeutic range with frequent adverse effects making therapeutic drug monitoring essential. With 80% of cyclosporine sequestered in erythrocytes, whole blood is the preferred specimen for analysis.

Reference Values

No definitive therapeutic or toxic ranges have been established.

 

Optimal blood drug levels are influenced by type of transplant, patient response, time posttransplant, coadministration of other drugs, and drug formulation.

 

The following 2-hour postdose cyclosporine ranges are only suggested guidelines:

Kidney transplant: 800-1700 ng/mL

Liver transplant: 600-1000 ng/mL

 

Target steady-state peak concentrations vary depending on the type of transplant, concomitant immunosuppression, clinical/institutional protocols, and time posttransplant. Results should be interpreted in conjunction with this clinical information and any physical signs/symptoms of rejection/toxicity.

Interpretation

No definitive therapeutic or toxic ranges have been established for postdose peak monitoring. Preferred therapeutic ranges may vary by transplant type, protocol, and comedications. The 2-hour postdose cyclosporine ranges listed for this test are only suggested guidelines.

 

This assay is specific for cyclosporine; it does not cross-react with cyclosporine metabolites, sirolimus, sirolimus metabolites, tacrolimus, or tacrolimus metabolites. Results by liquid chromatography with detection by tandem mass spectrometry are approximately 30% less than by immunoassay.

Method Description

Blood specimens are subjected to protein precipitation. The resulting supernatant is analyzed by liquid chromatography tandem mass spectrometry.(Bjergum MW, Jannetto PJ, Langman LJ. Simultaneous determination of tacrolimus and cyclosporine A in whole blood by ultrafast LC-MS/MS. Methods Mol Biol. 2019;1872:111-118. doi:10.1007/978-1-4939-8823-5_11)

Day(s) Performed

Monday through Sunday

Report Available

Same day/1 to 2 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.

CPT Code Information

80158

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CYCPK Cyclosporine, Peak, B 53834-8

 

Result ID Test Result Name Result LOINC Value
42398 Cyclosporine, Peak, B 53834-8
DATEC Date of last dose 29742-4
TIMEC Time of last dose 29637-6
DOSEC Dose, mg 4207-7

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)