Description

INTENDED USE

ELITech Clinical Systems CHOLINESTERASE is an in vitro diagnostic reagent intended for the quantitative determination of cholinesterase in human serum and plasma samples on analyzers.

This in vitro diagnostic device is for professional use only.

CLINICAL SIGNIFICANCE

Cholinesterase (serum cholinesterase or pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I. The biological function of cholinesterase is unknown. Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme.

In clinical practice, serum cholinesterase serves as an indicator of possible organo- phosphate insecticide poisoning or follow-up of personal working with these products. In pre-operative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants. Cholinesterase may also be measured as an index of liver function.

LIMITATION OF USE

The quantitative assay of cholinesterase alone cannot be used to diagnose a disease or a specific pathology.

The results must be interpreted in conjunction with other diagnostic test results, clinical findings and the patient’s medical history.

MATERIALS REQUIRED BUT NOT PROVIDED

• CALI-0550 ELICAL 2
• CONT-0060 ELITROL I
• CONT-0160 ELITROL II
• Normal saline solution (NaCl 9 g/L).
• Analyzers or semi-automatic
• General Laboratory equipment (e.g. pipette).
• Do not use materials that are not required as indicated