Test Catalog

Test Id : OMHC

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Oxcarbazepine Metabolite, Serum

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Overview

Test Catalog

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)

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

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 validated for testing

Serum Red

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

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

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

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Collect specimen immediately before next scheduled dose.

2. Within 2 hours of collection, 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:

-Neurology Specialty Testing Client Test Request (T732)

-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.

0.5 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
Ambient 28 days
Frozen 28 days

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

Monitoring serum concentration during oxcarbazepine therapy

 

Assessing compliance

 

Assessing potential toxicity

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 monohydroxy carbamazepine (MHC), an active metabolite that is responsible for OCBZ's therapeutic effect. The elimination half-life is approximately 2 hours for OCBZ and 7 to 11 hours for MHC. The therapeutic range (10-35 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: 10-35 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Therapeutic ranges are based on specimens collected 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 10 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 collection.

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

1. Hiemke C, Bergemann N, Clement HW, et al: Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51(1-02):9-62

2. Perucca E. Clinical pharmacology and therapeutic use of the new antiepileptic drugs. Fundam Clin Pharmacol. 2001;15(6):405-417

3. Lloyd P, Flesch G, Dieterle W. Clinical pharmacology and pharmacokinetics of oxcarbazepine. Epilepsia. 1994;35(Suppl 3):S10-S13

4. Gonzalez-Esquivel DF, Ortega-Gavilan M, Alcantara-Lopez G, Jung-Cook H. Plasma level monitoring of oxcarbazepine in epileptic patients. Arch Med Res. 2000;31(2):202-205

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

6. Patsalos PN, Berry DJ, Bourgeois BFD, 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

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

The serum sample is diluted in acetonitrile containing internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted with mobile phase for detection by a tandem mass spectrophotometer.(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 Saturday

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.

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

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 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.

80183

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
OMHC Oxcarbazepine Metabolite (MHC), S 31019-3
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.
81030 Oxcarbazepine Metabolite (MHC), S 31019-3

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