Thermo Kit Opiate OFT MCC

Thermo Kit Opiate OFT MCC

Intended Use

The Thermo Scientific CEDIA Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 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 morphine 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. 

Codeine and morphine appear in oral fluid within an hour after administration of opiates and remain in saliva up to 24 hours. Heroin and its metabolites, 6-Acetylmorphine (6-AM) and morphine were reported to be at higher concentrations in saliva compared to plasma for the first hour following Intramuscular administration (IM) of heroin and remained at higher levels in saliva for up to six hours.

CEDIA Opiate 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 Opiate OFT Assay
• Detectable Analytes: Opiates (Morphine)
• DoA Calibrators: CEDIA Multi-Drug OFT
• Quantity: 1 x 65mL
• Storage Requirements: 2° to 8°C