Test Catalog

Test Id : BUPMX

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Buprenorphine and Norbuprenorphine, Chain of Custody, Random, Urine

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Monitoring of compliance of buprenorphine therapy

 

Detection and confirmation of the illicit use of buprenorphine

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was always under the control of personnel involved with testing the specimen; this control implies that the opportunity for specimen tampering would be limited.

Additional Tests
Lists tests that are always performed, at an additional charge, with the initial tests.

Test Id Reporting Name Available Separately Always Performed
COCH Chain of Custody Processing No Yes
ADLTX Adulterants Survey, CoC, U Yes Yes

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain-of-custody urine samples as per regulatory requirements.

Method Name
A short description of the method used to perform the test

Immunoassay/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.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Buprenorphine w/metabolite, CoC, U

Aliases
Lists additional common names for a test, as an aid in searching

Buprenex

Suboxone

Subutex

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain-of-custody urine samples as per regulatory requirements.

Specimen Type
Describes the specimen type validated for testing

Urine

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

Supplies: Chain of Custody Kit (T282)

Container/Tube: Chain of custody kit containing specimen containers, seals, and required documentation.

Specimen Volume: 5 mL

Collection Instructions: Collect specimen in the container provided, seal, and submit with the associated documentation to satisfy the legal requirements for chain-of-custody testing.

Forms

1. Chain of Custody Request is included in the Chain-of-Custody Kit (T282).

2. 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. The minimum volume is sufficient for one attempt at testing.

1 mL

Reject Due To
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

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

Monitoring of compliance of buprenorphine therapy

 

Detection and confirmation of the illicit use of buprenorphine

 

Chain of custody is required whenever the results of testing could be used in a court of law. Its purpose is to protect the rights of the individual contributing the specimen by demonstrating that it was always under the control of personnel involved with testing the specimen; this control implies that the opportunity for specimen tampering would be limited.

Testing Algorithm
Delineates situations when tests are added to the initial order. This includes reflex and additional tests.

Adulterants testing will be performed on all chain-of-custody urine samples as per regulatory requirements.

Clinical Information
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.

 

Chain of custody is a record of the disposition of a specimen to document each individual who collected, handled, and performed the analysis. When a specimen is submitted in this manner, analysis will be performed in such a way that it will withstand regular court scrutiny.

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.

Negative

 

Cutoff concentrations:

Buprenorphine: 5.0 ng/mL

Norbuprenorphine: 2.5 ng/mL

Interpretation
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

Urine concentrations do not correlate well with serum drug levels and are not intended for therapeutic drug management.

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Elkader A, Sproule 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;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;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;188(1-3):144-151

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

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

Preliminary screen is performed by immunoassay.

 

This assay is a homogeneous enzyme immunoassay technique and is performed semi-quantitatively. The assay is based on competition between free drug in the urine sample, and a drug labeled with the enzyme glucose-6-phosphate dehydrogenase for a fixed amount of specific antibody binding sites. Active enzyme reduces nicotinamide adenine dinucleotide (NAD[+]) to NADH, which results in an absorbance change that can be measured spectrophotometrically at 340 nm.(Package insert: Buprenorphine Urine Enzyme Immunoassay. Immunalysis Corporation; 04/2021)

 

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 tandem 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

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.

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.

3 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

14 days

Performing Laboratory Location
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.

  • 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 account representative. 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.

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
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.

80348

G0480 (if appropriate)

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
BUPMX Buprenorphine w/metabolite, CoC, U 69033-9
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
56644 Buprenorphine Immunoassay Screen 58359-1
65215 Buprenorphine 3415-7
48297 Norbuprenorphine 49753-7
56645 Chain of Custody 77202-0

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.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

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.

SI Normal Reports | SI Abnormal Reports