DOA BUP One Step Buprenorphine rapid Test with CE certificate urine Uncut sheet

One Step Buprenorphine Test is a rapid one step test for the qualitative detection of Buprenorphine and its principal metabolites in human urine at specified cut-off level.

For in vitro diagnostic use only. For healthcare professional use only.

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.

Test must be in room temperature (15ºC to 30ºC)

PERFORMANCE CHARACTERISTICS

A. Sensitivity

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

C. Interfering substances

Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Aci, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step Buprenorphine Test at a concentration of 100 µg/ml.

SUMMARY

Buprenorphine is a potent analgesic often used in the treatment of opioid addiction. The drug is sold under the trade names Subutex, Buprenex, Temgesic and Suboxone, which contain Buprenorphine HCl alone or in combination with Naloxone HCl. Therapeutically, Buprenorphine is used as a substitution treatment for opioid addicts. Substitution treatment is a form of medical care offered to opiate addicts (primarily heroin addicts) based on a similar or identical substance to the drug normally used. In substitution therapy, Buprenorphine is as effective as Methadone but demonstrates a lower level of physical dependence. Concentrations of free Buprenorphine and Norbuprenorphine in urine may be less than 1 ng/mL after therapeutic administration, but can range up to 20 ng/mL in abuse situations. The plasma half-life of Buprenorphine is 2-4 hours. While complete elimination of a single-dose of the drug can take as long as 6 days, the detection window for the parent drug in urine is thought to be approximately 3 days. Wondfo One Step Buprenorphine Test is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Buprenorphine in urine. The One Step Buprenorphine Test yields a positive result when the Buprenorphine in urine exceed 10 ng/ml.