The BUP Rapid Test Dipstick (Urine) is a Rapid chromatographic immunoassay for qualitative detection of Buprenorphine in human urine at a cut-off concentration of 10 ng/mL which is only utilized for in vitro diagnostics (IVD). It merely provides a preliminary result, therefore, an alternative method with more specificity is recommended to be used to confirm the initial results, in which case, the most preferred method is gas chromatography-mass spectrometry (GC-MS). In cases of drug abuse, especially when the test result is positive, clinical and expert observations are required.

Summary

Buprenorphine is a strong painkiller often used to treat addiction. It is sold under brand names Suboxone, Temgesic, Buprenex, and Subutex containing Buprenorphine HCI combined with Naloxone HCI. Therapeutically, Buprenorphine is an alternative treatment for drug addicts. This kind of treatment is a method of medical care used for addicts to drugs such as heroin. In alternative treatment, Buprenorphine is as strong and effective as methadone, but its addiction rate is less than methadone. The concentrations of Buprenorphine and norBuprenorphine in the urine might be less than 10 ng/mL after therapeutical confirmation, but go up to 20 ng/mL for drug abuse. The half-life of Buprenorphine plasma is 2 to 4 hours. While a complete omission of one dose takes around 6 days, the detection source for the main drug in the urine is approximately 3 days. Buprenorphine rapid test is a quick urine screening method which could be performed without laboratory equipment. This test employs monoclonal antibodies for the specific detection of high levels of Buprenorphine in the urine. BUP rapid test result becomes positive when the level of Buprenorphine exceeds 10 ng/mL.

Rapid Buprenorphine urine test employs an immunochromatographic method based on competitive binding. Substances that may be found in the urine specimen compete with ones metabolized by the liver to bind to antibodies. During the test, the urine specimen flows upward via capillary action. If the amount of Buprenorphine in the urine is below 10 ng/mL, it does not bind to the binding sites of the antibodies coated with gold nanoparticles. Consequently, the antibody conjugated with nanoparticles will be absorbed by the Buprenorphine on the surface of the membrane and will leave a colored line in the test area (T). Should the amount be greater than 10 ng/mL, no colored line will appear in the T area, since all the binding sites of the Buprenorphine antibodies are occupied. So, if the presence of Buprenorphine in the urine specimen is positive, no colored line will be formed in the test area (T) due to drug competition, whereas if the urine specimen contains Buprenorphine amounts lower than the desired level in the test, a colored line will appear in this area. In order to have a procedural control, a colored line always appears in the area of the control line (C), indicating the appropriate volume of the specimen added to the membrane.