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Setia Scientific Solution
Setia Scientific Solution SA0258107-X

14-Jan-2020

¡¾SUMMARY¡¿
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. The elimination half-life of buprenorphine is 20–73 hours (mean 37). 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.
The BUP assay contained within the BUP Rapid Test Cassette/Midstream yields a positive result when the BUP concentration in saliva exceeds 10ng/ml.
 
 
¡¾DIRECTIONS FOR CASSETTE USE¡¿
Allow the test cassette, specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.
1. Remove the test cassette from the sealed pouch and use it within one hour.
2. Remove the collector from the sealed pouch and insert the sponge end of the collector into the mouth. Actively swab the inside of the mouth and tongue to collect oral fluid for a total of 3 minutes until the sponge becomes fully saturated. Gentle pressing the sponge between the tongue and teeth will assist saturation. No hard spots should be felt on the sponge when saturated.
3. Remove the collector from the mouth. Place saturated oral fluid collector into chamber and press sponge fully against the strainer to collect oral fluid. Discard the collector. Snap the cap shut on the collection chamber.
4. Place the test cassette on a clean and level surface. Unscrew cap cover from the collection chamber. Invert the collection chamber and transfer 3 drops of oral fluid (approximately 120 µL) into specimen well of the test cassette and start the timer. Avoid trapping air bubbles in the specimen well. Place screw cap on the collection chamber. See illustration below.
5. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not read results after 1 hour.
6. Apply the security seal over screw cap and send to the laboratory for confirmation if necessary.

¡¾DIRECTIONS FOR DEVICE USE¡¿
Allow the test device, specimen, and/or controls to reach room temperature (15-30ºC) prior to testing. Instruct the donor to not place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection.
1. Remove the test device from the sealed pouch and use it within one hour.
2. Take off the device cap and insert the absorbent wick to the mouth, put it under the tongue to collect oral fluid until the control line appears.
3. Put the device cap back outside of the absorbent wick and lace the test midstream on a clean and level surface. See illustration below.
4. Read results at 10 minutes. Do not read results after 1 hour.

 

 

 

 

Cat. No.

Product Description

Specimen

Format

Kit Size

Cut-Off

Status

DBU-802

Buprenorphine (BUP) Rapid Test Cassette

Oral Fluid

Cassette

25 T

10 ng/mL*

CE

DBU-803

Buprenorphine (BUP) Rapid Test Device

Oral Fluid

Device

25 T

10 ng/mL*

CE


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Setia Scientific Solution SA0258107-X
Suite 33-01, 33rd Floor, Menara Keck Seng, 203, Jalan Bukit Bintang, 55100 Kuala Lumpur, Malaysia.

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