Test Catalog

Test Id : RUFI

Rufinamide, Serum

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

Monitoring serum rufinamide concentrations, assessing compliance, and adjusting dosage in patients receiving other drugs which interact pharmacokinetically with rufinamide (ie, drugs that induce liver CYP3A4 enzymes) and may be helpful in who are receiving hemodialysis

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

Rufinamide, S

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

Rufinamide (Banzel)

Banzel (Rufinamide)

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

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. Centrifuge and aliquot serum into 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

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 rufinamide concentrations, assessing compliance, and adjusting dosage in patients receiving other drugs which interact pharmacokinetically with rufinamide (ie, drugs that induce liver CYP3A4 enzymes) and may be helpful in who are receiving hemodialysis

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

Rufinamide is a new antiepileptic drug (AED) approved by the Food and Drug Administration as add-on treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in children 4 years of age or older and for the treatment of focal seizures in adults and adolescents. Its mechanism of action is not completely understood, but it is believed to work by prolonging the inactive state of sodium channels and therefore limiting excessive firing of sodium-dependent action potentials. The most commonly observed side effects are headache, dizziness, fatigue, somnolence, and nausea.

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.

5.0-30.0 mcg/mL

Interpretation
Provides information to assist in interpretation of the test results

The reference interval is broad and represents the concentrations observed to be associated with the greatest drug efficacy without side effects or toxicity.

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
Recommendations for in-depth reading of a clinical nature

1. Krazowski MD: Antiepileptic drugs. Therapeutic drug monitoring of the new generation drugs. Clinical Laboratory News. 2013;39(6):8-10

2. Aneja S, Sharma S: Newer anti-epileptic drugs. Indian Pediatr. 2013:50(10):1033-1040

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

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

Deuterated internal standard in methanol will be added to the standards, controls, and patient serum samples. The samples will then be centrifuged and the supernatant will be further diluted with mobile phase A and analyzed by ultrafast online solid phase extraction- tandem mass spectrometry (UF-SPE-MS/MS).(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, Wednesday, Friday

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.

1 to 3 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 Regional Manager. 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. 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.

80210

LOINC® Information

Test Id Test Order Name Order LOINC Value
RUFI Rufinamide, S 59323-6
Result Id Test Result Name Result LOINC Value
Result LOINC Value Tooltip
63030 Rufinamide, S 59323-6

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