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Test Code OPATS Opiate Panel, Free (Unconjugated), Serum


Ordering Guidance


This test should only be ordered by healthcare professionals to monitor patients who have been prescribed any of the following opiates/opiates antagonists: codeine, oxycodone, noroxycodone, oxymorphone, hydrocodone, norhydrocodone, dihydrocodeine, morphine, 6-monoacetylmorphine, hydromorphone, and noroxymorphone.



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 serum

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.


Secondary ID

623435

Useful For

Monitoring therapeutic efficacy, compliance, misuse and/or abuse in serum specimens of patients who have been prescribed any of the following: codeine, hydrocodone, oxycodone, morphine, hydromorphone, oxymorphone,  and dihydrocodeine,

 

Detection and quantification of codeine, hydrocodone, oxycodone, morphine, hydromorphone, oxymorphone, noroxycodone, noroxymorphone, norhydrocodone, dihydrocodeine, and 6-monoacetylmorphine

Method Name

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

Reporting Name

Opiate Panel, Free (Unconjugated),S

Specimen Type

Serum Red

Specimen Minimum Volume

Serum: 0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Serum Red Refrigerated (preferred) 14 days
  Frozen  28 days
  Ambient  24 hours

Reject Due To

Gross hemolysis Reject
Gross lipemia OK
Gross icterus OK

Clinical Information

Opiates are the natural or synthetic drugs that have a morphine-like pharmacological action. They are used primarily for relief of pain and often produce physical and psychological dependence. This test is for use by healthcare professionals to determine if patients prescribed any of the following opiates/opioids are receiving the right dose for therapeutic efficacy and/or are compliant: codeine, oxycodone, noroxycodone, oxymorphone, hydrocodone, norhydrocodone, dihydrocodeine, morphine, 6-monoacetylmorphine, hydromorphone, and noroxymorphone.

Reference Values

Therapeutic range/Metabolite information (as applicable):

6-monoacetylmorphine: Metabolite of heroin

Codeine: 10-100 ng/mL

Morphine: 10-80 ng/mL when used as sole therapy; Minor metabolite of codeine

Hydromorphone: 1.0-30 ng/mL when used as sole therapy; Metabolite of hydrocodone and minor metabolite of morphine

Hydrocodone: 10-100 ng/mL

Dihydrocodeine: 72-150 ng/mL when used as sole therapy; Minor metabolite of hydrocodone

Norhydrocodone: Metabolite of hydrocodone

Oxycodone: 10-100 ng/mL

Noroxycodone: Metabolite of oxycodone

Oxymorphone: 1.0-8.0 ng/mL when used as sole therapy; Metabolite of oxycodone

Noroxymorphone: Metabolite of oxymorphone

 

Cutoff concentrations:

6-Monoacetylmorphine: 1.0 ng/mL

Codeine: 1.0 ng/mL

Morphine: 1.0 ng/mL

Hydromorphone: 1.0 ng/mL

Hydrocodone: 1.0 ng/mL

Dihydrocodeine: 1.0 ng/mL

Norhydrocodone: 1.0 ng/mL

Oxycodone: 1.0 ng/mL

Noroxycodone: 1.0 ng/mL

Oxymorphone: 1.0 ng/mL

Noroxymorphone: 1.0 ng/mL

Interpretation

Clinically, the presence of oxycodone, noroxycodone, oxymorphone, noroxymorphone, morphine, hydrocodone, norhydrocodone, hydromorphone, dihydrocodeine, codeine, and/or 6-monoacetylmorphine in serum can be

used to verify adherence or compliance to prescribed opioids, and discourage drug misuse, abuse, and diversion.

 

The following adult therapeutic ranges are suggested by literature but must be interpreted alongside other clinical features/test results, symptoms, collection time since last dosage was taken, and signs of abuse/misuse.

6-monoacetylmorphine: Not established, it is a metabolite of heroin

Codeine: 10-100 ng/mL

Morphine: 10-80 ng/mL when used as sole therapy; it is also a minor metabolite of codeine

Hydromorphone: 1.0-30 ng/mL when used as sole therapy; it is also a metabolite of hydrocodone and minor metabolite of morphine.

Hydrocodone: 10-100 ng/mL

Dihydrocodeine: 72-150 ng/mL when used as sole therapy; it is also a minor metabolite of hydrocodone.

Norhydrocodone: Not established; it is a metabolite of hydrocodone.

Oxycodone: 10-100 ng/mL

Noroxycodone: Not established; it is a metabolite of oxycodone.

Oxymorphone: 1.0-8.0 ng/mL when used as sole therapy; it is a metabolite of oxycodone.

Noroxymorphone: Not established; it is a metabolite of oxymorphone.

Cautions

Any aberrant result should be discussed with the patient and could be confirmed by re-testing or using an alternative matrix (eg, urine).

Clinical Reference

1. Jannetto PJ, Bratanow NC, Clark WA, et al. 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. doi:10.1373/jalm.2017.023341

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

Method Description

The opiates are extracted from serum using a solvent to precipitate proteins. The supernatant is removed and analyzed by liquid chromatography tandem mass spectrometry.(Unpublished Mayo method)

Day(s) Performed

Wednesday

Report Available

2 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

G0480

80361 (if appropriate for select payers)

80365 (if appropriate for select payers)

80356 (if appropriate for select payers)

Clinical Toxicology CPT Code Client Guidance

LOINC Code Information

Test ID Test Order Name Order LOINC Value
OPATS Opiate Panel, Free (Unconjugated),S In Process

 

Result ID Test Result Name Result LOINC Value
623436 6-monoacetylmorphine - Free 49749-5
623437 Codeine - Free 12784-5
623438 Morphine - Free 11244-1
623439 Hydromorphone - Free 12787-8
623440 Hydrocodone - Free 12786-0
623441 Dihydrocodeine - Free 12785-2
623442 Norhydrocodone - Free In Process
623443 Oxycodone - Free 12789-4
623444 Noroxycodone - Free In Process
623445 Oxymorphone - Free 46974-2
623446 Noroxymorphone - Free In Process