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Test Code TRAMS Tramadol and Metabolite, Serum


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (Serum gel/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Within 2 hours of collection, centrifuge and aliquot serum into a plastic vial.


Secondary ID

623268

Useful For

This test is useful to help determine compliance and/or to monitor adverse drug reactions or efficacy

Method Name

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

Reporting Name

Tramadol and metabolite, S

Specimen Type

Serum Red

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK

Clinical Information

Tramadol is a synthetic opioid that is approximately equipotent with codeine but is considered to cause less respiratory depression and have less abuse potential. It is US Food and Drug Administration-approved for moderate to severe pain. It is available in immediate-release and extended-release tablets. It is extensively metabolized by CYP2D6 and CYP3A4 and has an active metabolite (O-desmethyltramadol). The eliminate half-life is approximately 5 hours to 7 hours (immediate-release) and approximately 6 hours to 10 hours (extended-release).

Reference Values

Tramadol:

Peak plasma levels following a single 100 mg oral dose: 230-380 ng/mL

Steady-state plasma levels following a 100 mg 4 times daily regimen: 420-770 ng/mL

 

O-desmethyltramadol:

Peak plasma concentration following a single 100 mg oral dose: 35-75 ng/mL

Steady-state plasma concentration following a 100 mg 4 times daily regimen: 80-140 ng/mL

 

Cutoff concentrations by liquid chromatography tandem mass spectrometry:

Tramadol: 10 ng/mL

O-desmethyltramadol: 5.0 ng/mL

Interpretation

Serum concentrations of tramadol and its active metabolite can be used to determine compliance and usage of tramadol within the past several days. In a group of 28 adult patients receiving daily oral immediate-release doses of 200 mg to 400 mg for 4 weeks, serum concentrations measured 12 hours after the last dose averaged 365 ng/mL (range: 95-841 ng/mL) for tramadol and 59 ng/mL (range: 5-123 ng/mL) for O-desmethyltramadol.(1)

Cautions

Specimens collected in serum gel tubes are not acceptable because the drug can absorb on the gel and lead to falsely decreased concentrations.

Clinical Reference

1. Sindrup SH, Madsen C, Brosen K, Jensen TS. The effect of tramadol in painful polyneuropathy in relation to serum drug and metabolite levels. Clin Pharmacol Ther. 1999;66(6):636-641. doi:10.1053/cp.1999.v66.103171001

2. Langman LJ, Bechtel LK, Holstege CP. Clinical toxicology. In: Rifai N, Chiu RWK, Young I, Burnham C-AD, Wittwer CT, eds. Tietz Textbook of Laboratory Medicine. 7th ed. Elsevier; 2023:chap 43

3. Baselt RC. Disposition of Toxic Drugs and Chemical in Man. 12th ed. Biomedical Publications; 2020

4. Jannetto PJ, Bratanow NC, Clark WA, et al. Executive summary: American Association of Clinical Chemistry Laboratory Medicine Practice Guideline-using clinical laboratory tests to monitor drug therapy in pain management patients. J Appl Lab Med. 2018;2(4):489-526

Method Description

The serum samples are mixed with internal standard and extracted by protein crash with methanol. The supernatant after centrifugation is diluted with clinical laboratory reagent water. The sample is then analyzed by liquid chromatography tandem mass spectrometer.(Unpublished Mayo method)

Day(s) Performed

Wednesday

Report Available

3 to 9 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

80299

LOINC Code Information

Test ID Test Order Name Order LOINC Value
TRAMS Tramadol and metabolite, S In Process

 

Result ID Test Result Name Result LOINC Value
623268 Tramadol 12437-0
623269 O-desmethyltramadol 82974-7