Thermo Kit Cocaine TSC

Specifications

Control Sets: MGC Multi-Drug Controls

Description: CEDIA Cocaine Drugs of Abuse Assays

Detectable Analytes: Benzoylecgonine

DoA Calibrators: CEDIA Multi-Drug Calibrators

Quantity: 3 x 17mL

Storage Requirements: 2° to 8°C

Intended Use

The CEDIATM Cocaine assay is an in-vitro diagnostic medical device intended for the qualitative and semiquantitative assay of cocaine metabolites in human urine. 

Summary and Explanation of the Test

Cocaine (benzoylmethylecgonine), is derived from the plant species Erythroxylon coca, which is widely grown in South America.

Cocaine is rapidly metabolized, with less than 5% excreted unchanged in the urine. The two major metabolites, which result from enzymatic and nonenzymatic hydrolysis, are benzoylecgonine and ecgonine methyl ester. The metabolites may be detectable in urine for up to 3 weeks after long term, heavy use of cocaine.

The CEDIA Cocaine assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system.11 This assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, drug in the sample competes with drug conjugated to one inactive fragment of β-galactosidase for antibody binding site. If drug is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If drug is not present in the sample, antibody binds to drug conjugated on the inactive fragment, inhibiting the reassociation of inactive β-galactosidase fragments, and no active enzyme will be formed. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of drug present in the sample.