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One Step Buprenorphine Test has set the screen cut-off for positive specimens at10 ng/mL for Buprenorphine as a calibrator. The test device has been proved to detect above 10 ng/ml of Buprenorphine in urine at 5 minutes.
B. Specificity and cross reactivity
To test the specificity of the test, the test device was used to test Buprenorphine, its metabolites and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.
Component
Concentration (ng/ml)
Buprenorphine
10
Buprenorphine 3-D-Glucuronide
15
Norbuprenorphine
20
Norbuprenorphine 3-D-Glucuronide
200
INTENDED USE
The One Step Buprenorphine Test is a lateral flow chromatographic immunoassay for the detection of Buprenorphine in human urine at the cut-off concentration of 10 ng/ml. This assay provides only a qualitative, preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
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Will I need to do anything to prepare for the test?
Be sure to tell the testing professional if you are taking any prescription drugs, over-the-counter medicines, or supplements, because these substances may affect your test results. Also, you should avoid foods with poppy seeds, which can show up as opiates in a drug test.
Are there any risks to the test?
There are no known physical risks to having a drug test. But if drugs show up in your results, it may affect your job, your eligibility to play sports, the outcome of a legal matter, or other parts of your life. Before you take a drug test, make sure you know: What you are being tested for Why you are being tested How the results will be used. If you have questions or concerns about a drug test, talk with your provider or the person or organization that is asking for the test.