BUP-U01B (BUP) Buprenorphine Test Strip

1.Application

Buprenorphine (BUP) Single Drug Test Strip is a rapid urine drug screening test that can be performed without the use of an instrument.

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.

2.Principle

Buprenorphine (BUP) Drug Test Device is an immunoassay based on the principle of competitive binding.Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

One Step Buprenorphine Drug Test Device is a rapid urine drug screening test that can be performed without the use of an instrument.During testing,a urine specimen migrates upward by capillary action. Buprenorphine, if present in the urine specimen below 10 ng/mL,will not saturate the binding sites of antibody-coated particles in the test.

The antibody-coated particles will then be captured by immobilized Buprenorphine conjugate and a visible colored line will show up in the test line region.

The colored line will not form in the test line region if the Buprenorphine level exceeds 10 ng/mL because it will saturate all the binding sites of anti-Buprenorphine antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition,while a drug-negative urine specimen or a specimen containing a drug concentration lower than the cut-off will generate a line in the test line region.

To serve as a procedural control,a colored line will always appear at the control line region,indicating that proper volume of specimen has been added and membrane wicking has occurred.

3. Specification:

• Specimen:Urine

• Cut-off:10ng/ml

• Formats:Strip

• Usage:home-testing,self-testing,professional-testing

• Inner Packing:1 test/pouch with desiccant,cassette with dropper

• Certificate:CE, ISO & FDA

• Accurate Results in 5 Minutes

• Convenient Test Procedure

• Storage:Room temperature

• Shelf life:24 months from date of manufacture

2. Usage:

Allow test device,urine specimen,and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

• Bring the pouch to room temperature before opening it.Remove the test device from the sealed pouch and use it as soon as possible.

• Place the test device on a clean and level surface.Hold the dropper vertically and transfer 3 full drops of urine (approx. 100mL) to the specimen well (S) of the test device, and then start the timer.Avoid trapping air bubbles in the specimen well (S).See the illustration below.

• Wait for the colored line(s) to appear.The result should be read at 5 minutes.Do not interpret the result after 10 minutes

3. Results

NEGATIVE:Two lines appear. One colored line should be in the control region (C),and another colored line should be in the test region (T).This negative result indicates that the Benzoylecgonine concentration is below the detectable level (10 ng/mL).

NOTE:The shade of the color in the test region (T) may vary,but it should be considered negative whenever there is even a faint line.

POSITIVE: One colored line appears in the control region (C).No line appears in the test region.This positive result indicates that the Benzoylecgonine concentration is above the detectable level (10 ng/mL).

INVALID: Control line fails to appear.Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure.Review the procedure and repeat the test using a new test device.