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Test Code CARBG Carbamazepine-10,11-Epoxide, Serum

Useful For

Monitoring patients exhibiting symptoms of carbamazepine toxicity whose total serum carbamazepine concentration is within the therapeutic range, but who may be producing significant levels of the active metabolite epoxide, which can accumulate to concentrations equivalent to carbamazepine

Profile Information

Test ID Reporting Name Available Separately Always Performed
CARTA Carbamazepine, Tot, S Yes Yes
1011E Carb-10,11-Epoxide, S No Yes

Method Name

CARTA: Homogeneous Microparticle Agglutination Immunoassay

1011E: High-Performance Liquid Chromatography (HPLC)

Reporting Name

Carbamazepine-10,11-Epoxide, S

Specimen Type

Serum Red


Specimen Required


Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 2 mL

Collection Instructions:

1. Draw blood 12 hours (trough value) after last dose.

2. Centrifuge and aliquot serum into a plastic vial.


Specimen Minimum Volume

1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 7 days
  Frozen  28 days
  Ambient  48 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject
Gross icterus Reject

Clinical Information

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

CARBAMAZEPINE, TOTAL

Therapeutic: 4.0-12.0 mcg/mL

Critical value: ≥15.0 mcg/mL

 

CARBAMAZEPINE-10,11-EPOXIDE

Therapeutic concentration: 0.4-4.0 mcg/mL

Toxic concentration: ≥8.0 mcg/mL

Interpretation

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 ≤0.2 mcg/mL in symptomatic adults and ≤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

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.

Method Description

CARTA: The ONLINE TDM Carbamazepine Gen.4 assay is a homogeneous microparticle agglutination immunoassay. It is a 2-reagent system used for the detection of carbamazepine in serum. Kinetic interaction of microparticles (KIMS) will be measured using automated analyzers. In this technology biotinylated drug hapten attached to streptavidin coated latex beads serves as the binding partner to anti-carbamazepine antibody. A competitive reaction to a limited amount of specific anti-carbamazepine antibody takes place between the latex bound hapten and free carbamazepine in the serum sample. A decrease in the apparent signal is proportional to the amount of drug present in the sample.(Package insert: Roche Carbamazepine reagent, Roche Diagnostic Corp, Indianapolis, IN)

 

1011E: 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) Performed

CARTA: Monday through Sunday

1011E: Tuesday

Report Available

Same day/1 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

80156-Carbamazepine, Tot, S

80161-Carbamazepine-10,11-Epoxide 

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CARBG Carbamazepine-10,11-Epoxide, S 50337-5

 

Result ID Test Result Name Result LOINC Value
7467 Carb-10,11-Epoxide, S 9415-1
CARTA Carbamazepine, Tot, S 3432-2