Test Catalog

Test Id : LEVE

Levetiracetam, Serum

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

Monitoring serum concentration of levetiracetam, particularly in patients with kidney disease

 

Assessing compliance with levetiracetam therapy

 

Assessing potential toxicity of levetiracetam

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

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

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

Levetiracetam, S

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

Keppra (Levetiracetam)

Levetiracetam (Keppra)

Specimen Type
Describes the specimen type validated for testing

Serum

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Sarstedt Aliquot Tube 5 mL (T914)

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Draw blood immediately before next scheduled dose.

2. For sustained-release formulations only, draw blood a minimum of 12 hours after last dose.

3. Within 2 hours of collection, centrifuge, and aliquot serum into a plastic vial

Forms

If not ordering electronically, complete, print, and send 1 of the following forms with the specimen:

-Neurology Specialty Testing Client Test Request (T732)

-General Request (T239)

-Therapeutics Test Request (T831)

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

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

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

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 Refrigerated (preferred) 28 days
Ambient 28 days
Frozen 28 days

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

Monitoring serum concentration of levetiracetam, particularly in patients with kidney disease

 

Assessing compliance with levetiracetam therapy

 

Assessing potential toxicity of levetiracetam

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

Levetiracetam is approved for treatment of partial, myoclonic, and tonic-clonic seizures and is used off-label for manic states and migraine prophylaxis. Levetiracetam has very favorable pharmacokinetics with good bioavailability and rapid achievement of steady state. Its hepatic metabolism is minimal and nonoxidative, making it safe for use with hepatic enzyme inducers or inhibitors. The major metabolite is a carboxylic acid derivate, which is inactive and accounts for roughly one quarter of the administered dose. Levetiracetam is excreted renally, with a mean half-life of 7 hours in adults and slightly less than that in children. Kidney dysfunction may warrant therapeutic monitoring and/or dose adjustment.

 

Given the lack of drug interactions and favorable pharmacokinetics, the primary uses for therapeutic drug monitoring of levetiracetam are compliance assurance and management of physiological changes such as puberty, pregnancy, and aging. Toxicities associated with levetiracetam use include decreased hematocrit and red blood cell count, decreased neutrophil count, somnolence, asthenia, and dizziness. These toxicities may be associated with blood concentrations in the therapeutic range.

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.

10.0-40.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

Most individuals display optimal response to levetiracetam with serum levels 10.0 to 40.0 mcg/mL. Some individuals may respond well outside of this range or may display toxicity within the therapeutic range; thus, interpretation should include clinical evaluation.

 

Toxic levels have not been well established. Therapeutic ranges are based on specimen collected at trough (ie, immediately before the next dose).

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

This test cannot be performed on whole blood.

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

1. 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

2. Johannessen SI, Tomson T. Pharmacokinetic variability of newer antiepileptic drugs: when is monitoring needed? Clin Pharmacokinet. 2006;45(11):1061-1075

3. Hiemke C, Bergemann N, Clement HW, et al. Consensus guidelines for therapeutic drug monitoring in neuropsychopharmacology: Update 2017. Pharmacopsychiatry. 2018;51(1-02):9-62

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

The serum sample is diluted in acetonitrile containing internal standard. The protein precipitate is centrifuged, and a portion of the supernatant is diluted with mobile phase for detection by a tandem mass spectrometer.(Unpublished Mayo method)

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 to 2 days

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

14 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 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
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.

80177

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
LEVE Levetiracetam, S 30471-7
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.
83140 Levetiracetam, S 30471-7

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 | 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