Test Catalog

Test Id : TAPEN

Tapentadol and Metabolite, Random, Urine

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

Monitoring of compliance utilizing tapentadol

 

Detection and confirmation of the illicit use of tapentadol

 

This test is not intended for use in employment-related testing

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

Tapentadol and Metabolite, U

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

Nucynta

Nucynta ER

Specimen Type
Describes the specimen type validated for testing

Urine

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

Supplies: Aliquot Tube, 5 mL (T465)

Collection Container/Tube: Plastic urine container

Submission Container/Tube: Plastic, 5-mL tube

Specimen Volume: 1 mL

Collection Instructions: No preservative.

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

  All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

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
Urine Refrigerated (preferred) 14 days
Ambient 14 days
Frozen 14 days

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

Monitoring of compliance utilizing tapentadol

 

Detection and confirmation of the illicit use of tapentadol

 

This test is not intended for use in employment-related testing

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

Tapentadol, a centrally acting opioid analgesic, is used in the treatment of moderate to severe acute and chronic pain and for the management of neuropathic pain associated with diabetic peripheral neuropathy in adults (extended release formulation only). Tapentadol acts as an opiate agonist through its binding to mu-opioid receptors and through the inhibition of norepinephrine reuptake. About 97% of the parent drug is metabolized. The major pathway of tapentadol metabolism is conjugation with glucuronic acid to produce glucuronides. Tapentadol and its metabolites (N-desmethyltapentadol and hydroxyl-tapentadol) are excreted almost exclusively via the kidneys and approximately 70% of the drug is excreted in urine in the conjugated form. The metabolites of tapentadol have no analgesic activity. The half-life of tapentadol is approximately 4 hours.

 

Opioid analgesics have high abuse potential and the regular use of tapentadol may result in physical dependence and tolerance. Tapentadol is a schedule II-controlled substance with abuse liability similar to other opioid agonists.

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.

Cutoff: 25 ng/mL

 

Note: Tapentadol concentrations will be reported quantitatively and N-desmethyltapentadol will be reported qualitatively (Present or Negative).

Interpretation
Provides information to assist in interpretation of the test results

The presence of tapentadol or N-desmethyltapentadol levels of 25 ng/mL or higher is a strong indicator that the patient has used tapentadol.

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

Urine concentrations do not correlate well with serum drug levels and are not intended for therapeutic drug management.

 

Results are intended to be interpreted by a physician or health care professional.

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

1. Wade WE, Spruill WJ: Tapentadol hydrochloride: a centrally acting oral analgesic. Clin Ther. 2009;31(12):2804-2818. doi: 10.1016/j.clinthera.2009.12.003

2. Tzschentke TM, Christoph T, Kogel B, et al: (-)-(1R,2R)-3-(3-Dimethylamino-1-ethyl-2-methyl-propyl)-phenol hydrochloride (tapentadol HCL): a novel mu-opioid receptor agonist/norepinephrine reuptake inhibitor with broad-spectrum analgesic properties. J Pharmacol Exp Ther. 2007;323:265-276. doi: 10.1124/jpet.107.126052

3. Langman LJ, Bechtel L, Meier BM, Holstege CP: Clinical toxicology In: Rifai N, Horwath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887

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

Isotopically labeled tapentadol and N-desmethyltapentadol are added to the sample as internal standards. The sample is then diluted with deionized water and the analytes are separated by liquid chromatography and then quantified by mass spectrometry 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.

Tuesday, Thursday

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.

2 to 7 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 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.

80372

G0480 (if appropriate)

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