Test Catalog

Test Id : MPA

Mycophenolic Acid, Serum

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

Monitoring therapy to ensure adequate blood levels and avoid over-immunosuppression

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.

Yes

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

Mycophenolic Acid, S

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

CellCept

MPA-G (Mycophenolic Acid Glucuronide)

Mycophenolate Mofetil

Myfortic

Specimen Type
Describes the specimen type validated for testing

Serum Red

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

Collection Container/Tube: Red top (serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood immediately before the next scheduled dose (trough).

2. Centrifuge and aliquot serum into a plastic vial.

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

0.25 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
Serum Red Refrigerated (preferred) 28 days
Frozen 28 days
Ambient 21 days

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

Monitoring therapy to ensure adequate blood levels and avoid over-immunosuppression

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

Mycophenolate mofetil (CellCept) is an immunosuppressive agent useful in organ transplantation. It is approved for use in renal, hepatic, and cardiac transplants. When mycophenolate mofetil enters the blood, it is immediately metabolized to the active drug, mycophenolic acid (MPA), which inhibits inosine monophosphate dehydrogenase and interferes with the de novo pathway of guanosine nucleotide synthesis selectively in lymphocytes. MPA inhibits proliferative responses of T and B lymphocytes to both mitogenic and allo-specific stimulation. MPA acts in the same fashion as azathioprine, and MPA is suggested as replacement therapy for azathioprine. The drug is deactivated by the hepatic enzyme, uridine diphosphate glucuronosyltransferase to form MPA glucuronide (MPA-G).

 

The principle clinical problem encountered in MPA therapy is excessive immunosuppression, which predisposes the patient to systemic infection. Measurement of the blood level of MPA and MPA-G can be useful to guide therapy.

 

Monitoring is recommended before and after making any changes to immunosuppressive therapy or when initiating or discontinuing concomitant medications. Additional monitoring is indicated if the MPA level is not in the therapeutic range or if a major change in health status occurs.

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.

MYCOPHENOLIC ACID (MPA)

1.0-3.5 mcg/mL

 

MPA GLUCURONIDE

35-100 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Trough steady-state serum levels of mycophenolic acid (MPA) (>2 weeks at the same dose) in the range of 1.0 to 3.5 mcg/mL indicate adequate therapy. MPA glucuronide (MPA-G) levels in the range of 35 to 100 mcg/mL indicate that the patient has normal uridine diphosphate glucuronosyltransferase (UGT) metabolic capacity. MPA-G levels are typically in the range of 100 to 250 mcg/mL during the 2 weeks following transplantation. MPA-G typically decreases after this initial post-transplant phase.

 

Trough steady-state serum MPA levels over 4.0 mcg/mL indicate that the patient is over-immunosuppressed and susceptible to systemic infections. Decreased dosages may be indicated in these cases.

 

Low MPA levels and high MPA-G levels suggest that the patient has an active UGT metabolic capability; higher doses may be required to maintain therapeutic levels of MPA. Some patients have a high UGT metabolic capacity. These patients may require 1 or more grams 3 times a day to maintain trough serum MPA levels in the range of 1.0 mcg/mL to 3.5 mcg/mL. They are likely to have MPA-G levels over 100 mcg/mL. MPA-G is inactive; MPA-G levels only describe the patient's metabolic status.

 

Patients who have low UGT conjugating capability may become over-immunosuppressed, indicated by a trough steady-state serum MPA level over 4.0 mcg/mL and an MPA-G level below 40 mcg/mL. Dose reduction or interval prolongation is indicated in this case.

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

Correct interpretation requires a trough serum specimen (just before the next regular dose). Specimens collected at other times in the dosing cycle are likely to have higher mycophenolic acid levels. In these cases, the reference range does not apply.

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

1. Moyer TP, Shaw LM. Therapeutic drug monitoring. In: Burtis CA, Ashwood ER, Bruns DE, eds. Tietz Textbook of Clinical Chemistry. 4th ed. WB Saunders Company; 2005:1237-1285

2. Milone M, Shaw LM. Therapeutic drugs and their management. In: Rifai N, Rossa WKC, Young I, Carey-Ann DB, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 42

3. Shaw LM, Sollinger HW, Halloran P, et al. Mycophenolate mofetil: a report of the consensus panel. Ther Drug Monit. 1995;17:690-699

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

Liquid chromatography tandem mass spectrometry is used to quantify the serum concentration of mycophenolic acid (MPA) and MPA glucuronide.(Unpublished Mayo method)

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

2 weeks

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 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.

80180

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
MPA Mycophenolic Acid, S 87432-1
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.
15226 Mycophenolic Acid 23905-3
15227 MPA Glucuronide 23906-1

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 | PHP Pdf | CMS 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