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Test Code TAPEN Tapentadol and Metabolite, Random, Urine

Secondary ID

62594

Useful For

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

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

Reporting Name

Tapentadol and Metabolite, U

Specimen Type

Urine


Ordering Guidance


 



Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Plastic urine container

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Collect a random urine specimen.

2. No preservative.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Urine Refrigerated (preferred) 14 days
  Ambient  14 days
  Frozen  14 days

Reject Due To

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

Clinical Information

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

Cutoff: 25 ng/mL

 

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

Interpretation

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

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

1. Tapentadol. In: Merative Micromedex. Merative; Accessed February 09, 2024. Available at: www.micromedexsolutions.com/

2. Jutkiewicz EM, Traynor JR. Opioid analgesics. In: Brunton LL, Knollmann BC, eds. Goodman & Gilman's: The Pharmacological Basis of Therapeutics. 14th ed. McGraw-Hill Education; 2023

3. Langman LJ, Bechtel LK, Holstege CP. Clinical toxicology. In: Rifai N, Chiu RWK, Young I, Burnham CAD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:454-454

Day(s) Performed

Tuesday, Thursday

Report Available

2 to 6 days

Specimen Retention Time

14 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

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

80372

G0480 (if appropriate)

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TAPEN Tapentadol and Metabolite, U 101401-8

 

Result ID Test Result Name Result LOINC Value
35916 Tapentadol 65807-0
35917 N-desmethyltapentadol 65808-8

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.

Method Description

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)