The BUP Rapid Test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of the major metabolite of buprenorphine, buprenorphine-3-β-d-glucoronide, in human urine specimens at cut-off level of 10 ng/mL. This assay has not been evaluated in the point of care location and is for use by Healthcare Professionals only.
The test device should be stored at 2 to 30°C and will be effective until the expiration date stated on the package. The product is humidity-sensitive and should be used immediately after being open. Any improperly sealed product should be discarded.
The cut-off concentration (sensitivity level) of BUP test is determined to be 10 ng/ml of buprenorphine-3-β-d-glucoronide or 10 ng/ml of buprenorphine.