Mycophenolic Acid, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring therapy with CellCept to ensure adequate blood levels and avoid overimmunosuppression
Tandem Mass Spectrometry (MS/MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Mycophenolic Acid, S
MPA-G (Mycophenolic Acid Glucuronide)
MPA-G (Mycophenolic Acid Glucuronide)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Container/Tube: Red top
Specimen Volume: 1 mL
Forms: If not ordering electronically, submit a General Request Form (Supply T239) with the specimen.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
Serum gel tube
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum Red||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Mycophenolate mofetil (CellCept) is a new 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 allospecific 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 mycophenolic acid 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 immediately after transplant up to 3 weeks after therapy is initiated to evaluate dosing adequacy. 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)
Trough serum levels of mycophenolic acid (MPA) at steady-state (>2 weeks at the same dose) in the range of 1.0 to 3.5 mcg/mL indicate adequate therapy. Mycophenolic acid 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 >4.0 mcg/mL indicate that the patient is overimmunosuppressed 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 gram or more 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 >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 overimmunosuppressed, indicated by a trough steady-state serum MPA level >4.0 mcg/mL and a MPA-G level <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 drawn 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 Provides recommendations for further in-depth reading of a clinical nature
Moyer TP, Shaw LM: Therapeutic drug monitoring. In Tietz Textbook of Clinical Chemistry. Fourth edition. Edited by CA Burtis, ER Ashwood, DE Bruns. Philadelphia, WB Saunders Company, 2005, pp 1237-1285
Method Description Describes how the test is performed and provides a method-specific reference
Tandem mass spectrometry is used to quantify the serum concentration of mycophenolic acid (MPA) and mycophenolic acid glucuronide (MPA-G). The test involves direct measurement of serum for MPA and MPA-G.(Moyer TP, Shaw LM: Therapeutic drug monitoring. In Tietz Textbook of Clinical Chemistry. Fourth edition. Edited by CA Burtis, ER Ashwood, DE Bruns. Philadelphia, WB Saunders Company, 2005, pp 1237-1285)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Sunday; Varies
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
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 The location of the laboratory that performs the test
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's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) 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 U.S. 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 Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|