Test Catalog

Test Id : CYSPR

Cyclosporine, Blood

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

Monitoring whole blood 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

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

Cyclosporine, B

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

CSA Level

Gengraf

Neoral

Sandimmune (Cyclosporine)

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. Collect specimen 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 specimens 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
Clotted specimens 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 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. Dose is adjusted initially (up to 2 months posttransplant) to maintain concentrations generally between 150 and 400 ng/mL. Target trough concentrations vary according to clinical protocol and depend on type of allograft, risk of rejection, concomitant immunosuppressive drugs, and toxicity. After the first 2 postoperative months, the target range is generally lower, between 75 and 300 ng/mL. Conversion between formulations is generally done at the same dose but with drug monitoring.

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.

100-400 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 cyclosporine with trough whole blood levels 100 to 400 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 the next scheduled dose). Higher results will be obtained when the blood is drawn at other times.

 

This test may also be used to analyze cyclosporine levels 2 hours after dosing (C2 concentrations); trough therapeutic ranges do not apply to C2 specimens.

 

The 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

The recommended therapeutic ranges described above apply to trough specimens collected just before a dose. Blood drawn at other times will yield higher results.

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

1. 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 March;63(3):241-247

2. Kahan BD, Keown P, Levy GA, Johnston A: Therapeutic drug monitoring of immunosuppressant drugs in clinical practice. Clin Ther. 2002 March;24(3):330-350

3. 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

4. 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

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

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 day

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.

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
CYSPR Cyclosporine, B 3520-4
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.
35143 Cyclosporine, B 3520-4

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