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Test ID: OMHC
Oxcarbazepine Metabolite (MHC), Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

81030

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

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

Monitoring serum concentration during oxcarbazepine therapy

 

Assessing compliance

 

Assessing potential toxicity

Method Name A short description of the method used to perform the test

High-Turbulence Liquid Chromatography Mass Spectrometry (HTLC-MS/MS)

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

Oxcarbazepine Metabolite (MHC), S

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

10-Hydroxy-10,11-Dihydrocarbamazepine (Metabolite of Oxcarbazepine)
10-Hydroxycarbazepine
MHC (Oxcarbazepine Metabolite)
MHD (Oxcarbazepine Metabolite)
Monohydroxy Carbamazepine
Oxcarbazepine Metabolite (MHC)
Trileptal (Oxcarbazepine)

Specimen Type Describes the specimen type needed for testing

Serum

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: 

Preferred: Red top

Acceptable: Serum gel

Specimen Volume: 0.2 mL

Collection Instructions:

1. Draw specimen immediately before next scheduled dose.

2. Spin down within 2 hours of draw.

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.

0.1 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)14 days
 Ambient 14 days
 Frozen 14 days

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

Oxcarbazepine (OCBZ) is approved as monotherapy and adjunctive therapy for partial seizures with and without secondary generalized seizures in adults and as adjunctive therapy for partial seizures in children. In humans, OCBZ is a prodrug that is almost immediately and completely metabolized to 10-hydroxy-10,11-dihydrocarbamazepine, known as monohydroxycarbamazepine (MHC), an active metabolite that is responsible for OCBZ's therapeutic effect. The elimination half-life is 1 to 2.5 hours for OCBZ and 8 to 10 hours for MHC. The therapeutic range (3–35 mcg/mL) is based on concentrations of the metabolite, not the parent drug; this assay measures the metabolite only.

 

In clinical practice, the OCBZ dosage should be individually adjusted for each patient to achieve the desired therapeutic response. Toxicity associated with OCBZ includes hyponatremia, dizziness, somnolence, diplopia, fatigue, nausea, vomiting, ataxia, abnormal vision, abdominal pain, tremor, dyspepsia, and abnormal gait. These toxicities may be observed when blood concentrations are in the therapeutic range.

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.

Oxcarbazepine metabolite: 3-35 mcg/mL

Interpretation Provides information to assist in interpretation of the test results

Therapeutic ranges are based on specimens drawn at trough (ie, immediately before the next dose). Most individuals display optimal response to oxcarbazepine therapy when serum levels of the metabolite (measured in this assay) are between 3 mcg/mL and 35 mcg/mL. Some individuals may respond well outside of this range, or may display toxicity within the therapeutic range. Thus, interpretation should include clinical evaluation.

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

Toxic levels have not been well established.

 

This test cannot be performed on whole blood. Serum must be separated from cells within 2 hours of draw.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Patsalos P, Berry D, Bourgeois B, et al:  Antiepileptic drugs-best practice guidelines for therapeutic drug monitoring: a position paper by the subcommission on therapeutic drug monitoring, ILAE Commission on Therapeutic Strategies. Epilepsia 2008;49(7):1239–1276

2. Johannessen S, Tomson T:  Pharmacokinetic variability of newer antiepileptic drugs:  when is monitoring needed? Clin Pharmacokinet 2006;45(11):1061-1075

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

High-turbulence liquid chromatography-tandem mass spectrometry

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 Friday

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.

2 days

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

3 days

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 The location of the laboratory that performs the test

Rochester

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.

80299

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 IDReporting NameLOINC Code
81030Oxcarbazepine Metabolite (MHC), S31019-3