Test Catalog

Test Id : LACO

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Lacosamide, Serum

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Overview

Test Catalog

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

Monitoring serum concentrations of lacosamide to ensure compliance and appropriate dosing in specific clinical conditions (ie, severe kidney impairment, mild-to-moderate hepatic impairment, and kidney failure)

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

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

Portions of this test are covered by patents held by Quest Diagnostics

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

Lacosamide, S

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

VIMPAT

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)

Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Collect specimen immediately before next scheduled dose.

2. For sustained-release formulations ONLY, collect specimen a minimum of 12 hours after last dose.

3. Centrifuge and aliquot serum into plastic vial within 2 hours of collection.

Forms

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

-Neurology Specialty Testing Client Test Request (T732)

-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.

0.2 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 concentrations of lacosamide to ensure compliance and appropriate dosing in specific clinical conditions (ie, severe kidney impairment, mild-to-moderate hepatic impairment, and kidney failure)

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

Lacosamide is approved for adjunctive therapy to treat partial-onset seizures in epileptic patients aged 17 years and older. In clinical trials, the most common side effects were dizziness, headache, nausea, and double vision. Lacosamide is completely absorbed after oral administration with negligible first-pass metabolism. Peak serum concentrations occur 1 to 4 hours after oral dosing, and the elimination half-life is approximately 13 hours. Steady-state serum concentrations are achieved after 3 days of twice daily repeated administration. About 40% of the administered dose is eliminated by the renal system unchanged, and 30% is metabolized by hepatic isoenzymes (CYP2C9, CYP2C19, and CYP3A4) to the O-desmethyl inactive metabolite. The relationship between lacosamide serum concentrations and its efficacy or adverse effects is not well established. However, central nervous system toxicity has been associated with higher drug concentrations in serum.

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 lacosamide concentrations of 1.0 to 10.0 mcg/mL.

Interpretation
Provides information to assist in interpretation of the test results

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 or adverse effects, particularly when lacosamide is co-administered with other anticonvulsant drugs.

 

Toxic ranges are not well established but occur more frequently when concentrations are greater or equal to 20 mcg/mL.

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

Abnormalities in liver function tests (eg, alanine aminotransferase) have been observed in controlled trials in adult patients with partial-onset seizures who were taking 1 to 3 concomitant antiepileptic drugs.

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

1. VIMPAT Medication Guide. Harris FRC Corporation. UCB, Inc; Revised 09/2022. Accessed April 23, 2024. Available at www.ucb-usa.com/vimpat-prescribing-information.pdf

2. Patsalos PN, Berry DJ. Pharmacotherapy of the third-generation AEDs: lacosamide, retigabine and eslicarbazepine acetate. Expert Opin Pharmacother. 2012;13(5):699-715

3. Chung SS. New treatment option for partial-onset seizures: efficacy and safety of lacosamide. Ther Adv Neurol Disord. 2010;3(2):77-83

4. Sattler A, Schaefer M, May TW, Rambeck B, Brandt C. Fluctuation of lacosamide serum concentrations during the day and occurrence of adverse drug reactions-first clinical experience. Epilepsy Res. 2011;95(3):207-212

5. Greenaway C, Ratnaraj N, Sander JW, Patsalos PN. Saliva and serum lacosamide concentrations in patients with epilepsy. Epilepsia. 2011;52(2):258-263

6. McMullin M, Dalrymple R. Analysis for lacosamide in human serum by LC/MS/MS and a summary of 8,000 patient values. Ther Drug Monit. 2011;33(4):520-521

7. 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. doi:10.1055/s-0043-116492

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

Lacosamide and the internal standard are separated from other serum constituents by high-performance liquid chromatography with analysis on a tandem mass spectrometer equipped with an electrospray ion source using multiple reaction monitoring.(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 Saturday

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 4 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.

80235

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
LACO Lacosamide, S 59297-2
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.
62772 Lacosamide, S 59297-2

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