Thermo Kit Heroin Mtb Rgt CEDIA

Specifications

Control Sets: MGC Select DAU Control Set

Description: CEDIA Heroin Metabolite (6-Acetylmorphine) Drugs of Abuse Assay for Indiko

Detectable Analytes: 6-Acetylmorphine

DoA Calibrators: CEDIA Heroin Metabolite Calibrators

Quantity: 3 x 17mL

Storage Requirements: 2° to 8°C

Intended Use

The CEDIA® Heroin Metabolite (6-Acetylmorphine, or 6-AM) Assay is a homogeneous enzyme immunoassay for the in vitro qualitative and semiquantitative determination of heroin metabolite (6-AM) in human urine on automated clinical chemistry analyzers. Measurements are used as an aid in the detection of heroin use or overdose.

Summary and Explanation of the Test

Heroin (3,6-diacetylmorphine) is produced by chemical modification of morphine, a naturally occurring alkaloid found in the unripe pods of the opium poppy Papaver somniferum. Heroin is highly addictive, and is currently a Schedule I substance (no currently accepted medical use). Heroin is the most abused opiate drug, and its use is associated with a wide variety of health problems. Heroin is administered by intravenous or subcutaneous injection or by nasal insufflation. It is rapidly metabolized (half-life of 9 minutes) to 6-AM by esterases in the blood, and then to morphine by hydrolysis in the liver. 

The presence of 6-AM in urine is regarded as a specific marker for the illicit use of heroin. 6-AM cannot be formed by acetylation of morphine in the body; thus the presence of 6-AM cannot be caused by injection of legal opiate analgesics or large quantities of poppy seeds. For this reason, the Department of Health and Human Services (DHHS) introduced revised guidelines for opiate testing which required testing of all opiate-positive urine specimens for 6-AM for confirmation of heroin abuse. The half-life of 6-AM is approximately 35 minutes. The time for which the measurement of 6-AM is diagnostic of heroin use is dependent on the amount of heroin taken. It is likely that even for higher doses of heroin the detection time is limited to 24 hours after use.

The CEDIA Heroin Metabolite Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system.10 This assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments, termed Enzyme Acceptor (EA) and Enzyme Donor (ED) 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 CEDIA Heroin Metabolite Assay, the sample competes with 6-AM conjugated to ED for antibody binding sites. If 6-AM is present in the sample, it binds to antibody, leaving the ED-6-AM conjugate free to reassociate with EA to form active β-galactosidase. If no 6-AM is present in the sample, antibody binds to the ED-6-AM conjugate, inhibiting the reassociation of inactive β-galactosidase fragments, and thus reducing the amount of active enzyme formed. The amount of active enzyme formed and resultant absorbance change are proportional to the amount of 6-AM present in the sample.