Thermo Kit PPx LC

Specifications

• Control Sets: MGC Multi-Drug Controls
• Description: CEDIA Propoxyphene Drugs of Abuse Assays
• Detectable Analytes: Propoxyphene
• DoA Calibrators: CEDIA Multi-Drug Calibrators
• Quantity: 495mL
• Storage Requirements: 2° to 8°C
  

Intended Use

The CEDIATM Propoxyphene assay is an in vitro diagnostic medical device intended for the qualitative and semiquantitative determination of propoxyphene in human urine.

Summary and Explanation of the Test

Propoxyphene is a mild narcotic analgesic that is structurally related to methadone. The abuse potential for this drug is comparable to codeine, and it is therefore classified as a Schedule IV drug under the U.S. Controlled Substances Act.

Propoxyphene produces central nervous system effects much like the opioids, including mild euphoria, drowsiness, abdominal pain, and, more seriously, delusions, stupor, coma, convulsions, respiratory depression, cardiac toxicity, and pulmonary edema when taken in greater-than recommended doses.

Propoxyphene is quickly absorbed and distributed after oral administration. It has a half life of approximately 15 hours (range, 8-24 hours). The rate of clearance of propoxyphene varies greatly from subject to subject, but, in general, up to 34% of an administered dose is eliminated in the urine within the first 20 hours and up to 75% of the dose is excreted over a 7-day period.

The CEDIA Propoxyphene 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 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.