Thermo Kit THC MCC

Specifications

• Control Sets: CEDIA THC Controls
• Description: CEDIA THC (Cannabinoid) Drugs of Abuse Assays
• Detectable Analytes: 11-nor-Δ9THC-COOH
• DoA Calibrators: CEDIA Multi-level THC Calibrators
• Quantity: 65mL
• Storage Requirements: 2° to 8°C
  

Intended Use

The CEDIATM THC Assay is an in-vitro diagnostic medical device intended for the qualitative and semiquantitative determination of cannabinoids (THC) in human urine. 

Summary and Explanation of Test

Marijuana and hashish come from the hemp plant Cannabis sativa, which grows throughout the world. These drugs contain at least 61 cannabinoids (a class of chemicals unique to the cannabis plant), of which ∆9-tetrahydrocannabinol (THC) is the primary psychoactive compound. THC acts as a mild sedative-hypnotic that may produce euphoria, heightened sensations, and, in higher doses, even hallucinations.

THC is highly fat soluble and therefore readily stored in fatty tissues, where it may remain in the body for several days or even weeks. It is rapidly transformed by liver enzymes to over 24 metabolites, the primary one being 11-nor-∆9-tetrahydrocannabinol-9-carboxylicacid. Approximately 70% of a THC dose is excreted in feces and urine within 72 hours of administration. The concentrations of THC metabolites in urine are influenced by several factors: the frequency of prior use, the timing of urine specimen collection in relation to the last exposure to THC, and the rate of release of stored cannabinoids from fatty tissues. Heavy chronic THC users who stop taking the drug may show positive urine tests for a month or longer.

The CEDIA Multi-Level THC assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. 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 will bind to antibody, leaving the inactive enzyme fragments free to form active enzyme. If drug is not present in the sample, antibody will bind 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.