Screening for drug abuse or use of buprenorphine
For screening with reflex confirmation of positive screening results, order BUPR / Buprenorphine Screen with Reflex, 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.
If urine creatinine is required or adulteration of the sample is suspected, the following test should also be ordered, ADULT / Adulterants Survey, Random, Urine.
Supplies: Sarstedt 5 mL Aliquot Tube (T914)
Collection Container/Tube: Plastic urine container
Submission Container/Tube: Plastic vial
Specimen Volume: 5 mL
1. Collect a random urine specimen.
2. Submit 5 mL in 1 plastic vial.
3. No preservative.
1. No specimen substitutions.
2. STAT requests are not accepted for this test.
3. Submitting less than 5 mL will compromise the ability to perform all necessary testing.
If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.
|Specimen Type||Temperature||Time||Special Container|
|Urine||Refrigerated (preferred)||14 days|
Screening for drug abuse or use of buprenorphine
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 (CYP 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)
This procedure uses immunoassay reagents that are designed to produce a negative result when no drugs are present in a natural (ie, unadulterated) specimen of urine; the assay is designed to have a high true-negative rate. Like all immunoassays, it can produce a false-positive result due to cross-reactivity with natural chemicals and drugs other than those they were designed to detect. The immunoassay also can produce a false-negative result due to the antibody's ability to cross-react with different drugs in the target class.
Screening cutoff concentration:
Buprenorphine: 5 ng/mL
This assay only provides a preliminary analytical test result. A more specific alternative method (ie, liquid chromatography-tandem mass spectrometry: LC-MS/MS) must be used to obtain a confirmed analytical result.
Care should be taken when interpreting results since there are many factors (eg, fluid intake and other biologic factors) that may influence a urine test result. It is possible that substances other than those investigated in the specificity study may interfere with the test and cause false-positive or false-negative results.
1. Elkader A, Spuroule B: Buprenorphine clinical pharmacokinetics in the treatment of opioid dependence. Clin Pharmacokinet 2005;44(7):661-680
2. Jannetto PJ, Bratanow NC, Clark WA, et al: Executive summary: 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 Jan;2(4):489-526. doi: 10.1373/jalm.2017.023341
3. Langman LJ, Bechtel LK, Meier BM, Holstege CP: Clinical Toxicology. In: Rifai N, Horvath AR, Wittwer CT, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 6th ed. Elsevier; 2018:832-887
This assay is a homogeneous enzyme immunoassay technique. The assay will be 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 340nm. Similar testing is being performed on the Olympus AU680 analyzer and this test would be an addition to the current testing.(Package insert: Buprenorphine Urine Enzyme Immunoassay. Immunalysis Corporation; 04/2021)
Monday through Saturday
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.
|Test Id||Test Order Name||Order LOINC Value|
|BUPS||Buprenorphine Screen, U||3415-7|
|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.
|63119||Buprenorphine Screen, U||3415-7|
|Change Type||Effective Date|
|Test Status - Test Resumed||2022-11-10|
|Test Status - Test Delay||2022-11-01|