NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Monitoring serum concentration of lamotrigine
Adjusting lamotrigine dose in patients receiving other anticonvulsant drugs which interact pharmacokinetically with lamotrigine
High Turbulence Liquid Chromatography-Tandem Mass Spectrometry (HTLC-MS/MS)
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Specimen Type Describes the specimen type needed for testing
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.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 1 mL
Collection Instructions: Draw specimen immediately before next scheduled dose or at least 12 hours 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.
Mild OK; Gross reject
Mild OK; Gross reject
Mild OK; Gross reject
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Lamotrigine (Lamictal) is approved for therapy of bipolar I disorder and a wide variety of seizure disorders including Lennox-Gastaut syndrome, primary generalized tonic-clonic seizures, and partial seizures. Its many off-label uses include treatment of migraine, trigeminal neuralgia, and treatment-refractory depression. Lamotrigine inhibits glutamate release (an excitatory amino acid) and voltage-sensitive sodium channels to stabilize neuronal membranes; it also weakly inhibits the 5-HT3 (serotonin) receptor.
Lamotrigine oral bioavailability is very high (approximately 98%).The drug is metabolized by glucuronic acid conjugation to inactive metabolites. The half-life is 25 to 33 hours in adults, but decreases with concurrent use of phenytoin or carbamazepine (13-14 hours), and increases with concomitant valproic acid therapy (59-70 hours), renal dysfunction, or hepatic impairment. The therapeutic range is relatively wide, 2.5 mcg/mL to 15 mcg/mL for most individuals. Common adverse effects are dizziness, ataxia, blurred or double vision, nausea, or vomiting.
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.
Patients receiving therapeutic doses usually have lamotrigine concentrations of 2.5-15.0 mcg/mL.
The serum concentration should be interpreted in the context of the patient's clinical response and may provide useful information in patients showing poor response (noncompliance?) or adverse effects, particularly when lamotrigine is co-administered with other anticonvulsant drugs.
While most patients show response to the drug when the trough concentration is in the range of 2.5 mcg/mL to 15.0 mcg/mL, and show signs of toxicity when the peak serum concentration is >20 mcg/mL, some patients can tolerate peak concentrations as high as 70 mcg/mL.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
No significant cautionary statements
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
1. Johannessen SI, Battino D, Berry DJ, et al: Therapeutic drug monitoring of the newer antiepileptic drugs. Ther Drug Monit 2003;25(3):347-363
2. Johannessen SI, Landmark CJ: Value of therapeutic drug monitoring in epilepsy. Expert Rev Neurother 2008;8(6):929-939
3. Johannessen SI, Tomson T: Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed? Clin Pharmacokinet 2006;45(11):1061-1075
4. Physician's Desk Reference. 61th Edition. Montvale, NJ: Thomson PDR, 2007
5. Goodman & Gilman's: The Pharmacological Basis of Therapeutics. 10th Edition. New York. McGraw-Hill Book Company 2001
Method Description Describes how the test is performed and provides a method-specific reference
Samples are diluted and extracted online extraction by high turbulence liquid chromatography (HTLC), with detection by tandem mass spectrometry (MS/MS).
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.
Monday through Sunday
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
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
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 Mayo Clinic in a manner consistent with CLIA requirements. 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.
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 ID||Reporting Name||LOINC Code|