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Test ID: C1011
Carbamazepine-10,11-Epoxide, Serum

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 patients exhibiting symptoms of carbamazepine toxicity whose serum carbamazepine concentration is within the therapeutic range, but who may be producing significant levels of the active metabolite epoxide

Profile Information A profile is a group of laboratory tests that are ordered and performed together under a single Mayo Test ID. Profile information lists the test performed, inclusive of the test fee, when a profile is ordered and includes reporting names and individual availability.

Test IDReporting NameAvailable SeparatelyAlways Performed
CARCarbamazepine, Total, SYesYes
1011ECarb-10,11-Epoxide, SNoYes

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

CAR/8654: Immunoassay

1011E/7467: High-Performance Liquid Chromatography (HPLC)

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

Carbamazepine-10,11-Epoxide, S

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

Carbamazepine (Carbatrol, Tegretol)
Carbamazepine Epoxide
Carbamazepine Metabolite
Carbatrol (Carbamazepine)
Epoxide 10, 11
Tegretol (Carbamazepine)

Specimen Type Describes the specimen type needed for testing

Serum Red

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: 2 mL

Collection Instructions: Draw blood 12 hours (trough value) after last dose.

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.

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

Whole blood, plasma, or 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.

Specimen TypeTemperatureTime
Serum RedRefrigerated (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

Carbamazepine is a common antiepileptic drug. It is a first-line drug for treatment of partial seizures  and trigeminal neuralgia.

 

Carbamazepine is metabolized by the liver to carbamazepine-10,11-epoxide (CBZ10-11) which is pharmacologically active and potentially toxic. CBZ10-11 is, in turn, inactivated by hepatic conversion to a transdiol derivative.

 

CBZ10-11 may be responsible for the congenital abnormalities that are sometimes associated with the use of carbamazepine during early pregnancy. There have been cases of severe seizures exacerbation when serum epoxide levels were increased. Toxic levels of CBZ10-11 can occur during:

-Concomitant administration of other drugs that induce hepatic oxidizing enzymes (eg, most antiepileptic drugs [with the exception of valproic acid and the benzodiazepines], propoxyphene)

-Concomitant administration of drugs that inhibit its breakdown such as valproic acid, felbamate, and lamotrigine

-High-dose carbamazepine therapy, especially in combination with the above conditions

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.

CARBAMAZEPINE, TOTAL

Therapeutic concentration: 4.0-12.0 mcg/mL

Toxic concentration: > or =15.0 mcg/mL

 

CARBAMAZEPINE-10,11-EPOXIDE

Therapeutic concentration: 0.4-4.0 mcg/mL

Toxic concentration: > or =8.0 mcg/mL

Interpretation Provides information to assist in interpretation of the test results

The clinically acceptable serum concentration of carbamazepine-10,11-epoxide (CBZ10-11) is not well established, but 4.0 mcg/mL has often been used as an upper limit for its therapeutic range.

 

The ratio of CBZ10-11 to carbamazepine is usually < or =0.2 mcg/mL in symptomatic adults and < or =0.3 mcg/mL in children.

 

Clinical correlation is aided by comparing values obtained when the patient is symptomatic with those obtained when the patient has improved.

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

Routine determination of carbamazepine-10,11-epoxide (CBZ10-11) is not clinically indicated. It should be considered when the source of treatment in associated symptoms is not obvious.

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

1. Theodore WH, Narang PK, Holmes MD, et al: Carbamazepine and its epoxide: relation of plasma levels to toxicity and seizure control. Ann Neurol 1989;25:194-196

2. Tomson T, Almkvist O, Nilsson BY, et al: Carbamazepine-10, 11-epoxide in epilepsy. A pilot study. Arch Neurol 1990;47:888-892

3. McKauge L, Tyrer JH, Eadie MI: Factors influencing simultaneous concentrations of carbamazepine and its epoxide in plasma. Ther Drug Monit 1981;3:63-70

4. Brodie MJ, Forrest G, Rapeport WG: Carbamazepine-10,11-epoxide concentrations in epileptics of carbamazepine alone and in combination with other anticonvulsants. Br J Clin Pharmacol 1983;16:747-749

5. Shoeman JF, Elyas AA, Brett EM, Lascelles PT: Correlation between plasma carbamazepine-10,11-epoxide concentration and drug side-effects in children with epilepsy. Dev Med Child Neurol 1984;26:756-764

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

High-performance liquid chromatography (HPLC).(Chelberg RD, Gunawan S, Treiman DM: Simultaneous high-performance liquid chromatography determination of carbamazepine and its principal metabolites in human plasma and urine. Ther Drug Monit 1988;10:188-193)

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.

Tuesday; 9:00 a.m.

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

7 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 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 Laboratory Medicine and Pathology, Mayo Clinic. 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.

80156-Carbamazepine, total

80299-Carbamazepine-10,11-Epoxide

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
7467Carb-10,11-Epoxide, S9415-1
8654Carbamazepine, Total, S3432-2