Vitassay - Pancreatic Elastase Turbidimetry Assay CE/IVD

Intended Use
Vitassay Pancreatic Elastase–Turbidimetric Assay-is a rapid Turbidimetric assay for the quantitative detection of Pancreatic Elastase E1 in human stool samples.
Exocrine pancreatic insufficiency (EPI) is defined by a deficiency of exocrine pancreatic enzymes resulting in an inability to maintain normal digestion.
EPI is one of the major complications of chronic pancreatitis that has alcohol as the main etiological cause. Human Elastase is synthetized by the acinar cells of the pancreas along with the other proteolytic enzymes, and under normal conditions. An advantage of fecal elastase 1 as a diagnostic marker is its low variability within an individual from day to day, indicating that its measurement in fecal samples is valid diagnostically.
Simple, non-invasive, and highly sensitivity assay for the presumptive diagnosis of Pancreatic Elastase E1 in stool samples. This product is optimized for several automated analyzer. Test results should be exclusively used to evaluate exocrine pancreatic function in stool samples.
Vitassay Pancreatic Elastase–Turbidimetric Assay-is a quantitative turbidimetric assay for the detection of human Pancreatic Elastase E1 in human solid stool samples.
Vitassay Pancreatic Elastase Turbidimetric Assay is based on antigen-antibody agglutination reactions between the antigen contained in the sample and the antibodies anti-antigen coated on polystyrene latex particles. Such agglutination is measured as an increase in absorbance proportional to the quantity of antigen contained in the sample. The use of two external controls, Control 1 and Control 2, is used to verify that the testis working properly.

Kit Content:
▪Reagent R1
▪Reagent R2
▪Calibrator 0
▪Calibrator 1
▪Calibrator 2
▪Calibrator 3
▪Calibrator 4
▪Calibrator 5
▪Control 1
▪Control 2
▪Vials with diluent for the sample dilution.
▪Instruction for use