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HelpEpic Code LAB3256 Carbamazepine, Free and Total, Serum
Additional Codes
Mayo Code: CARFT
Epic Code: LAB 3256
Interface Code: 11584
Cerner: 2013
Performing Laboratory
Mayo Clinic Laboratories in Rochester
Useful For
Monitoring carbamazepine (free and total) therapy in patients who are uremic
Specimen Type
Serum RedSpecimen Required
Container/Tube: Red top (serum gel/SST are not acceptable)
Submission Container/Tube: Plastic vial
Specimen Volume: 2 mL
Collection Instructions: Centrifuge and aliquot serum into a plastic vial within 2 hours of collection.
COLLECTION NOTE: Volumes listed are in serum or plasma, draw approximately 2 1/2 times the requested volume in whole blood.
Minimum Volume: 4 mL
+(2)S/PO/R
Specimen Minimum Volume
1 mL
4 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 |
Day(s) Performed
Monday through Sunday
Reference Values
CARBAMAZEPINE, TOTAL
Therapeutic: 4.0-12.0 mcg/mL
Critical value: ≥15.0 mcg/mL
CARBAMAZEPINE, FREE
Therapeutic: 1.0-3.0 mcg/mL
Critical value: ≥4.0 mcg/mL
Clinical Information
Carbamazepine (Tegretol) is an effective treatment for complex partial seizures, with or without generalization to tonic-clonic seizures. It is frequently administered in conjunction with other antiepileptic agents, such as phenytoin and valproic acid.
Under normal circumstances, 75% of the carbamazepine that circulates in blood is protein bound. In severe uremia, carbamazepine may be displaced from protein, resulting in a higher free (unbound) fraction of the drug circulating in blood. Since neurologic activity and toxicity are directly related to the circulating free fraction of drug, adjustment of dosage based on knowledge of the free carbamazepine level may be useful in patients with severe uremia.
Cautions
Fresh serum with normal protein content is required for optimal analysis.
Specimens subjected to significant heat or other factors that cause protein denaturation demonstrate an artifactually increased free carbamazepine.
If hemolysis, lipemia, or icterus exceed the analytical interference threshold, the testing will be canceled.
Interpretation
In patients with normal kidney function, optimal response is often associated with free (unbound) carbamazepine levels greater than 1.0 mcg/mL, and toxicity may occur when the free carbamazepine is greater than or equal to 4.0 mcg/mL.
In uremic patients, the free carbamazepine level may be a more useful guide for dosage adjustments than the total level. In patients with severe uremia, subtherapeutic total carbamazepine levels in the range of 1.0 to 2.0 mcg/mL may be associated with therapeutic free levels. Toxicity may occur in these patients when the free carbamazepine level is greater than or equal to 4.0 mcg/mL (even though the total carbamazepine concentration is <15.0 mcg/mL).
As with the serum levels of other anticonvulsant drugs, total and free carbamazepine levels should be correlated with the patient's clinical condition. They are best used as a guide in dose adjustment.
Reporting Name
Carbamazepine, Free and Total, SMethod Name
CARF: Ultrafiltration Followed by Homogeneous Microparticle Agglutination Immunoassay
CARTA: Homogeneous Microparticle Agglutination Immunoassay
Method Description
Carbamazepine:
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 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: Carbamazepine reagent. Roche Diagnostics; 09/2021)
Free Carbamazepine:
Free carbamazepine is isolated from serum by ultrafiltration. 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 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: Carbamazepine reagent. Roche Diagnostics; 09/2021)
CPT Code Information
80156
80157
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| CARFT | Carbamazepine, Free and Total, S | 34545-4 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| CARF | Carbamazepine, Free, S | 3433-0 |
| CARTA | Carbamazepine, Tot, S | 3432-2 |
Report Available
Same day/1 dayTest 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.Clinical Reference
1. Svinarov DA, Pippenger CE. Relationships between carbamazepine-diol, carbamazepine-epoxide, and carbamazepine total and free steady-state concentrations in epileptic patients: the influence of age, sex, and comedication. Ther Drug Monit. 1996;18(6):660-665
2. Bernus I, Dickinson RG, Hooper WD, Eadie MJ. The mechanism of the carbamazepine-valproate interactions in humans. Br J Clin Phamacol. 1997;44(1):21-27
3. Dasgupta A, Volk A. Displacement of valproic acid and carbamazepine from protein binding in normal and uremic sera by tolmetin, ibuprofen, and naproxen: presence of inhibitor in uremic serum that blocks valproic acid-naproxen interactions. Ther Drug Monit. 1996;18(3):284-287
4. Moyer TP: Therapeutic drug monitoring. In: Burtis CA, Ashwood ER eds. Tietz Textbook of Clinical Chemistry. 4th ed. WB Saunders Company; 2005: 1237-1285
5. Patsalos PN, Berry DJ, Bourgeois BF, 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
6. Kanner A.M, Ashman E, Gloss D, et al. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs I: Treatment of new-onset epilepsy Report of the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology and the American Epilepsy Society. Neurology. 2018;91(2):74-81
Profile Information
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CARTA | Carbamazepine, Tot, S | Yes | Yes |
| CARF | Carbamazepine, Free, S | Yes | Yes |
Forms
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.