Test Id : CYCPK
Cyclosporine, Peak, Blood
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
A short description of the method used to perform the test
Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)
NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
CSA Level
Gengraf
Neoral
Sandimmune (Cyclosporine)
Cyclosporine Peak
Specimen Type
Describes the specimen type validated for testing
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.
ORDER QUESTIONS AND ANSWERS
| Question ID | Description | Answers |
|---|---|---|
| DATEC | Date of last dose | |
| TIMEC | Time of last dose | |
| DOSEC | Dose, mg |
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. 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.
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. The minimum volume is sufficient for one attempt at testing.
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 |
| Clotted specimen | Reject |
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) | 14 days | |
| Ambient | 14 days | ||
| Frozen | 14 days |
Useful For
Suggests clinical disorders or settings where the test may be helpful
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
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
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
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.
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
Provides information to assist in interpretation of the test results
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.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Established (trough) cyclosporine reference ranges do not apply to specimens collected after administration of a dose. For trough specimens, order CYCSP / Cyclosporine, Blood.
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. Moyer TP, Post GR, Sterioff S, Anderson CF. Cyclosporine nephrotoxicity is minimized by adjusting dosage on the basis of drug concentration in blood. Mayo Clin Proc. 1988;63(3):241-247
3. Kahan BD, Keown P, Levy GA, Johnston A. Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther. 2002;24(3):330-350
4. Dunn CJ, Wagstaff AJ, Perry CM, Plosker GL, Goa KL. Cyclosporin: an updated review of the pharmacokinetic properties, clinical efficacy, and tolerability of a microemulsion-based formulation (neoral) 1 in organ transplantation. Drugs. 2001;61(13):1957-2016
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.(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)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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 account representative. 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. It 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.
CPT codes are provided by the performing laboratory.
80158
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 |
|---|---|---|
| CYCPK | Cyclosporine, Peak, B | 53834-8 |
| 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.
|
|---|---|---|
| 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 |