Thermo Kit PCP OFT MCC

Thermo Kit PCP OFT MCC

Intended Use

The Thermo Scientific CEDIA PCP OFT Assay is intended for use in the qualitative determination of PCP in human oral fluid at a cutoff concentration of 3.0 ng/ml in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze® Oral Fluid Collection System. The assay is calibrated against PCP and performed on the MGC 240 analyzer. This in vitro diagnostic device is intended for clinical laboratory use only.

Summary and Explanation of the Test

The collection of oral fluid is less invasive and no special facilities are required. Oral fluid contains mostly parent drug and therefore is a better indicator of recent drug use. 

PCP is normally self-administered either by smoking, oral ingestion or by injection. PCP can be detected in saliva as a result of the exchange of drug between the circulatory system and the oral cavity. PCP levels were much higher in saliva than in plasma with the ratio of saliva/plasma between 1.5 and 3.0. Since the excretion of PCP and its metabolites in urine are pH dependent and lead to misinterpretation of results, saliva is a better medium for the determination of PCP.

CEDIA PCP OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

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

Specifications

• Control Sets: CEDIA Multi-Drug OFT
• Description: CEDIA Phencyclidine (PCP) OFT Assay
• Detectable Analytes: Phencyclidine (PCP)
• DoA Calibrators: CEDIA Multi-Drug OFT
• Quantity: 1 x 65mL
• Storage Requirements: 2° to 8°C