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HelpTest Code CARTF Carbamazepine Profile, 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
Free carbamazepine concentration may also be useful to monitor in patients with altered or unpredictable protein binding capacity
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CARTA | Carbamazepine, Tot, S | Yes | Yes |
| 1011E | Carb-10,11-Epoxide, S | No | Yes |
| CARF | Carbamazepine, Free, S | Yes | Yes |
Method Name
CARTA: Homogeneous Microparticle Agglutination Immunoassay
1011E: High-Performance Liquid Chromatography (HPLC)
CARF: Ultrafiltration Followed by Homogeneous Microparticle Agglutination Immunoassay
Reporting Name
Carbamazepine Profile, SSpecimen Type
Serum RedSpecimen Required
Container/Tube: Red top
Specimen Volume: 2 mL
Submission Container/Tube: Plastic vial
Collection Instructions:
1. Draw blood 12 hours (trough value) after last dose.
2. Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.
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: 0.4-4.0 mcg/mL
Toxic concentration: ≥8.0 mcg/mL
CARBAMAZEPINE, FREE
Therapeutic: 1.0-3.0 mcg/mL
Critical value: ≥4.0 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 less than or equal to 0.2 mcg/mL in symptomatic adults and less than or equal to 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.
Method Description
Carbamazepine, Total:
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 anticarbamazepine antibody. A competitive reaction to a limited amount of specific anticarbamazepine 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)
Carbamazepine, Free:
Free carbamazepine is isolated from serum by ultrafiltration.
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)
Carbamazepine-10,11-Epoxide:
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, CARF: Monday through Sunday
1011E: Tuesday
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test has been modified from the manufacturer's instructions. Its performance characteristics were determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
80156-Carbamazepine, total
80157-Carbamazepine, free
80161-Carbamazepine-10,11-Epoxide
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CARTF | Carbamazepine Profile, S | 50337-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| CARF | Carbamazepine, Free, S | 3433-0 |
| 7467 | Carb-10,11-Epoxide, S | 9415-1 |
| CARTA | Carbamazepine, Tot, S | 3432-2 |
Forms
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.