OVERVIEW

Purpose: Detection and quantification of buprenorphine. Preferred test to follow-up presumptive buprenorphine urine screening.

CLINICAL INFORMATION

In clinical practice, buprenorphine is utilized as a substitution therapy for opioid dependence and as an analgesic. Compared to morphine, buprenorphine is 25 to 40 times more potent. As with any opioid, abuse is always a concern. The metabolic pathway of buprenorphine entails N-dealkylation, which leads to the formation of norbuprenorphine. Subsequently, both the parent compound and its metabolite undergo glucuronidation. Norbuprenorphine, an active metabolite with around one-fifth of the potency of the parent, contributes to its pharmacological effects. The glucuronide metabolites, however, remain inert. The primary clinical utility of quantification of buprenorphine in urine is to identify patients that have strayed from opioid dependence therapy.

SPECIMEN COLLECTION

Specimen Type: Random Urine
Preferred Collection Container: Non-sterile specimen container
Specimen Required: 3 mL urine; minimum 1 mL

TEST DETAILS

Methodology: Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS)
Compliance Category: Laboratory Developed Test (LDT)
This test was developed and assessed by DMD in compliance with CLIA requirements for its analytical performance characteristics and clinical application. This test has not been cleared or approved by the U.S. Food and Drug Administration.
Reference Interval: Negative
Drug/Metabolite Tested:
Drug/Metabolite Cutoff concentration 500 ng/mL
Buprenorphine 10 ng/mL
Norbuprenorphine 20 ng/mL
CPT code(s): 80348
Turnaround Time: 90% < 48 hours, 50% < 24 hours

SPECIMEN PROCESSING

Transport Temperature: Refrigerated (preferred) or room temperature overnight shipping.
Specimen Stability: 3 days at room temperature and 14 days at refrigerated and frozen temperatures (to be further confirmed with our validation).
Rejection Criteria: Stability limits exceeded.

Director: Cheryl Hanau, MD; Donald Hall Jr., PhD; Garth Ehrlich, PhD; Yinghua Qiu, PhD, DABCC

Review Date: 08/28/2023

Note: The billing party has sole responsibility for CPT coding. Any questions regarding coding should be directed to the payer being billed. The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.

The information on these pages is provided for general information only and should not be used for diagnosis or treatment, or as a substitute for consultation with a physician or health care professional. If you have specific questions or concerns about your health, you should consult your health care professional.

 
 Back to Top