Test Catalog

Test Id : CARF

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Carbamazepine, Free, Serum

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Overview

Test Catalog

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

Monitoring unbound or free carbamazepine levels in patients where the total carbamazepine result is within the therapeutic range, but the patient is experiencing side effects

 

Monitoring carbamazepine (free) therapy in patients who are uremic

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

Ultrafiltration followed by Homogeneous Microparticle Agglutination Immunoassay

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

Carbamazepine, Free, S

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

CARBAMAZEPINE, FREE

Free Carbamazepine

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

Collection 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.

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory

1 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Gross hemolysis Reject

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) 7 days
Frozen 28 days
Ambient 48 hours

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

Monitoring unbound or free carbamazepine levels in patients where the total carbamazepine result is within the therapeutic range, but the patient is experiencing side effects

 

Monitoring carbamazepine (free) therapy in patients who are uremic

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Carbamazepine (Tegretol) is an effective treatment for complex partial seizures, with or without generalization to tonic-clonic seizures.(1) It is frequently administered in conjunction with other antiepileptic agents, such as phenytoin and valproic acid.(2) Under normal circumstances, the carbamazepine that circulates in blood is 70% to 80% protein-bound;(3) only the free drug is able to enter the interstitial space in the brain where the pharmacological effects occur.(4)

 

Patient management is best guided by monitoring free serum concentrations when protein binding is altered. Altered protein binding occurs in patients with hypoalbuminemia observed during pregnancy, in the malnourished, and liver disease. In patients with kidney disease, uremia may develop whose byproducts can displace bound carbamazepine increasing the unbound fraction. Administration of drugs that can compete for serum protein binding sites may also increase the unbound fraction of carbamazepine. Since neurologic activity and toxicity of carbamazepine are directly related to the circulating free fraction of drug, adjustment of dosage based on knowledge of the free carbamazepine concentration may be more useful in these patient populations.

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.

Therapeutic concentration: 1.0-3.0 mcg/mL

Critical value: > or =4.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

In patients with normal kidney function, optimal response is often associated with free (unbound) carbamazepine levels above 1.0 mcg/mL, and toxicity may occur when the free carbamazepine is greater than or equal to 4.0 mcg/mL.

 

Under normal circumstances, 75% of the carbamazepine that circulates in blood is protein-bound. Therapies or conditions such as uremia that displace carbamazepine from protein cause a higher free (unbound) fraction of the drug circulating in blood. In uremia, 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 carbamazepine levels. Toxicity may occur 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. Serum levels are best used as a guide in dose adjustment.

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

Fresh serum with normal protein content is required for optimal analysis.

 

Specimens subjected to significant heat or other factors that cause protein denaturation may demonstrate an artifactually increased free carbamazepine level.

 

If hemolysis, lipemia, or icterus exceed the analytical interference threshold, the testing will be canceled.

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

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 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

5. 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

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

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 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: Carbamazepine reagent. Roche Diagnostics; 09/2021)

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 Sunday

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.

Same day/1 day

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 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 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
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.

80157

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
CARF Carbamazepine, Free, S 3433-0
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.
CARF Carbamazepine, Free, S 3433-0

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 | PHP Pdf | CMS 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