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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
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: 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.
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. 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
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.
Negative (Positive result is reported with a quantitative result.)
Cutoff concentrations by liquid chromatography tandem mass spectrometry:
Tapentadol: 25 ng/mL
N-desmethyltapentadol: 25ng/mL; 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 other healthcare professional.
Clinical Reference
Recommendations for in-depth reading of a clinical nature
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 and 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
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
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
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
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.
CPT codes are provided by the performing laboratory.
G0480
80372 (if appropriate for select payers)
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 |
|---|---|---|
| TAPEN | Tapentadol and Metabolite, U | 101401-8 |
| 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.
|
|---|---|---|
| 35916 | Tapentadol | 65807-0 |
| 35917 | N-desmethyltapentadol | 65808-8 |