| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
Test Id : BUPM
Buprenorphine and Norbuprenorphine, Random, Urine
Useful For
Suggests clinical disorders or settings where the test may be helpful
Suggests clinical disorders or settings where the test may be helpful
Monitoring of compliance utilizing buprenorphine
Detection and confirmation of the illicit use of buprenorphine
Highlights
Detection of buprenorphine and norbuprenorphine in urine for compliance testing.
Method Name
A short description of the method used to perform the test
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.
Indicates the status of NY State approval and if the test is orderable for NY State clients.
Yes
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Lists a shorter or abbreviated version of the Published Name for a test
Buprenorphine and Metabolite, U
Aliases
Lists additional common names for a test, as an aid in searching
Lists additional common names for a test, as an aid in searching
Subutex
Suboxone
Buprenex
Specimen Type
Describes the specimen type validated for testing
Describes the specimen type validated for testing
Urine
Ordering Guidance
For screening buprenorphine alone, order BUPS / Buprenorphine Screen, Random, Urine.
For comprehensive opioid screening, order TOSU / Targeted Opioid Screen, Random, Urine.
For situations where chain of custody is required, a Chain of Custody Kit (T282) is available. For chain-of-custody testing, order BUPMX / Buprenorphine and Norbuprenorphine, Chain of Custody, Random, Urine.
Additional drug panels and specific requests are available. Call 800-533-1710 or 507-266-5700.
Additional Testing Requirements
If urine creatinine is required or adulteration of the sample is suspected, the following test should also be ordered, ADULT / Adulterants Survey, Random, Urine.
Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Defines the optimal specimen required to perform the test and the preferred volume to complete testing
Supplies: Aliquot Tube, 5 mL (T465)
Collection Container/Tube: Plastic urine container
Submission Container/Tube: Plastic, 5-mL tube
Specimen Volume: 1 mL
Collection Instructions:
1. Collect a random urine specimen.
2. No preservative
Additional Information:
1. No specimen substitutions.
2. STAT requests are not accepted for this test.
3. Submitting <1 mL will compromise our ability to perform all necessary testing.
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
Defines the amount of sample necessary to provide a clinically relevant result as determined by the Testing Laboratory
0.5 mL
Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected
Identifies specimen types and conditions that may cause the specimen to be rejected
| Gross hemolysis | OK |
| Gross icterus | OK |
Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included
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
Suggests clinical disorders or settings where the test may be helpful
Monitoring of compliance utilizing buprenorphine
Detection and confirmation of the illicit use of buprenorphine
Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Clinically, buprenorphine is utilized as a substitution therapy for opioid dependence and as an analgesic. Buprenorphine is a partial agonist of the mu-opioid receptor. These mu binding sites are discretely distributed in the human brain, spinal cord, and other tissue. The clinical effects of mu receptor agonists are sedation, euphoria, respiratory depression, and analgesia. As a partial mu receptor agonist, buprenorphine's clinical effects are decreased, giving buprenorphine a wider safety margin.(1) Buprenorphine has a prolonged duration of activity. The combination of decreased clinical effects and prolonged activity gives buprenorphine the added advantage of a delayed and decreased withdrawal syndrome, compared to other opioids.(1) Compared to morphine, buprenorphine is 25 to 40 times more potent.(1) As with any opioid, abuse is always a concern. To reduce illicit use of buprenorphine, it is available mixed with naloxone in a ratio of 4:1. When the combination is taken as prescribed, only small amounts of naloxone will be absorbed. However, if the combination is transformed into the injectable form, naloxone then acts as an opioid receptor antagonist.
Buprenorphine is metabolized through N-dealkylation to norbuprenorphine through cytochrome P450 3A4. Both parent and metabolite then undergo glucuronidation. Norbuprenorphine is an active metabolite possessing one-fifth of the potency of its parent. The glucuronide metabolites are inactive.(1)
The primary clinical utility of quantification of buprenorphine in urine is to identify patients that have strayed from opioid dependence therapy.
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.
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
Cutoff concentrations:
Buprenorphine: 5.0 ng/mL
Norbuprenorphine: 2.5 ng/mL
Interpretation
Provides information to assist in interpretation of the test results
Provides information to assist in interpretation of the test results
The presence of buprenorphine above 5.0 ng/mL or norbuprenorphine above 2.5 ng/mL is a strong indicator that the patient has used buprenorphine.
Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
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
Clinical Reference
Recommendations for in-depth reading of a clinical nature
Recommendations for in-depth reading of a clinical nature
1. Elkader A, Spuroule B: Buprenorphine: clinical pharmacokinetics in the treatment of opioid dependence. Clin Pharmacokinet. 2005;44(7):661-680
2. Grimm D, Pauly E, Poschl J, Linderkamp O, Skopp G: Buprenorphine and norbuprenorphine concentrations in human breast milk samples determined by liquid chromatography-tandem mass spectrometry. Ther Drug Monit. 2005 Aug;27(4):526-530
3. Kacinko SL, Shakleya DM, Huestis MA: Validation and application of a method for the determination of buprenorphine, norbuprenorphine, and their glucuronide conjugates in human meconium. Anal Chem. 2008 Jan 1;80(1):246-252
4. Concheiro M, Shakleya DM, Huestis MA: Simultaneous quantification buprenorphine, norbuprenorphine, buprenorphine-glucuronide and norbuprenorphine-glucuronide in human umbilical cord by liquid chromatography tandem mass spectrometry. Forensic Sci Int. 2009 Jul 1;188(1-3):144-151
5. Langman LJ, Bechtel LK, Meier BM, Holstege C: Clinical toxicology. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887
6. Baselt RC: Disposition of Toxic Drugs and Chemicals in Man. 10th ed. Biomedical Publications; 2014:2211
Method Description
Describes how the test is performed and provides a method-specific reference
Describes how the test is performed and provides a method-specific reference
Buprenorphine and its major metabolite (norbuprenorphine) are liberated from conjugation by enzyme hydrolysis. Acetonitrile is added to the sample and an aliquot of the supernatant is diluted with water. Analysis is performed by liquid chromatography-mass spectrometry/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
Indicates whether the report includes an additional document with charts, images or other enriched information
No
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.
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.
Monday through Friday
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.
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.
2 to 5 days
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
14 days
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Indicates the location of the laboratory that performs the test
Rochester
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.
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 Regional Manager. 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.
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. This test 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.
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.
80348
G0480 (if appropriate)
Test Setup Resources
Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.
Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.
Normal and Abnormal sample reports are provided as references for report appearance.
SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.