Drug Monitoring, Buprenorphine and Naloxone, Quantitative, Urine

Test Code
BUPREN


Quest Code
39391


CPT Codes
80348, 80362 (HCPCS: G0480)

Includes
If you require medMATCH for this order code, you must also order code 39158 - Prescribed Drugs, medMATCH®. If 39158 is ordered, all Drug Monitoring order codes will be treated as medMATCH.

If this test code is not ordered with 39158, all medMATCH result codes will be DNR’d.
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Buprenorphine, Norbuprenorphine, Naloxone


Preferred Specimen
3 mL urine collected in a clinical drug test transport vial


Minimum Volume
2 mL


Other Acceptable Specimens
Urine collected in urine collection container


Transport Temperature
Room temperature


Specimen Stability
Room temperature: 7 days
Refrigerated: 14 days
Frozen: 30 days


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Preserved samples


Methodology
Mass Spectrometry (MS)

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Mon-Sat; Report available: 3 days


Reference Range
Buprenorphine <2 ng/mL
Norbuprenorphine <2 ng/mL
Naloxone <2 ng/mL


Clinical Significance
This test measures levels of buprenorphine and its metabolite norbuprenorphine in urine. Buprenorphine and norbuprenorphine are biomarkers for monitoring possible use or non-use of buprenorphine. The test is a definitive drug assay using the liquid chromatography/mass spectrometry (LC/MS-MS) method of analysis.

Buprenorphine is an opioid analgesic used for moderate to moderately severe pain. Formulated with naloxone, buprenorphine is used to treat opioid substance use disorders. Less than 11% of the dose is excreted as free and conjugated unchanged drug, while less than 14% is excreted as free and conjugated metabolites [1].

According to the American Association for Clinical Chemistry (AACC), testing drugs/drug metabolites is recommended and effective for detecting the use of relevant over-the-counter, prescribed, and nonprescribed drugs, as well as illicit substances in pain-management patients [2]. Laboratory testing is more effective than other physician tools for the detection of these substances and is useful for routine monitoring of adherence. Instances where unchanged drug is detected, but metabolite(s) is not, may be indicative of drug added to the specimen after collection (eg, pill shaving, drug spiking) [2].

Note: No single monitoring approach provides adequate information about the pattern or dose of patient drug use. Safest prescribing habits should include a combination of tools and laboratory test results to correctly detect drug use patterns.

Urine drug test results equal to or greater than cutoff are reported as quantitative values and results less than cutoff are reported as negative. Quantitative values cannot be used to assess the drug dose because the drug is extensively metabolized and excreted in the urine.

References
1. Suboxone® [package insert]. Vacaville, CA: ALZA Corp; 2018.
2. AACC. Using clinical laboratory tests to monitor drug therapy in pain management patients. November 2017.
https://www.aacc.org/-/media/Files/Science-and-Practice/Practice-Guidelines/Pain-Management/LMPGPain-Management20171220.pdf. Accessed November 21, 2019.


Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Drive
Chantilly, VA 20153


Last Updated: October 13, 2021


The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.