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The LZI Buprenorphine II Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of norbuprenorphine in human urine at the cutoff value of 5 ng/mL when calibrated against norburprenorphine. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures

The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

The LZI Buprenorphine II Enzyme Immunoassay is a homogeneous enzyme immunoassay ready-to-use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, norbuprenorphine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody would bind to free drug; the unbound norbuprenorphine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

The LZI Buprenorphine II Enzyme Immunoassay is a kit comprised of two reagents, R₁ and R₂, which are bottled separately but sold together within the kit.

The R₁ solution contains mouse monoclonal anti-norbuprenorphine antibody, glucose-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09%) as a preservative. The R₂ solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with norbuprenorphine in buffer with sodium azide (0.09%) as a preservative.

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