CE ISO Buprenorphine (BUP) Diagnostic Test for Urine Sample Rapid Test

• Customization: Available
• Type: IVD Reagent
• Certificate: ISO, CE
• Model NO.: BUP-DU02
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Urine
• Result Time: Within 15 Mins
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 40test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

 

Intended Use

Buprenorphine(BUP) Rapid Test is an immuno-chromatographic assay for the qualitative determination of the presence of Buprenorphine(BUP) listed in the table below.
 

Drug(Identifier)	Calibrator	Cut-off level
Buprenorphine(BUP)	Buprenorphine	10 ng/mL

This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry(GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to Buprenorphine(BUP) of abuse test result, particularly when preliminary positive results are indicated.

 

Introduction

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.3 The plasma half life of Buprenorphine is 2-4 hours.3 While complete elimination of a single dose of the drug can take as long as 6 days, the window of detection for the parent drug in urine is thought to be approximately 3 days. Substantial abuse of Buprenorphine has also been reported in many countries where various forms of the drug are available. The drug has been diverted from legitimate channels through theft, doctor shopping, and fraudulent prescriptions, and been abused via intravenous, sublingual, intranasal and inhalation routes.

Contents

• Drug Test.
• Desiccant
• Leaflet with instruction for use.

Storage & Statibility

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

Operation

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

1. Donor collects urine specimen in a urine cup.

2. Open the sealed pouch by tearing along the notch. Remove the test from the pouch and place it on a level surface.

3. Hold the sample dropper vertically, and add exactly three drops of the urine specimen into the sample well.

4. The result should be read at 5 minutes. Do not interpret the result after 10 minutes. See the illustration below.
 

 

Interpretation of Results

Preliminary positive (+)

Only one colored band appears, in the control region (C). No colored band appears in the test region (T).

Negative (-)

Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

Invalid

Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

Detailed Photos

 

Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period of Corona, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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