AffiPCR® H.pylori Real Time PCR

Target Disease Type: Intestinal Infections

Specific Application: Helicobacter pylori

Storage and Shipping : 4 weeks

H.pylori RT-PCR (CE) B9-50FRT DataSheet

INTRODUCTION

Helicobacter pylori is a Gram-negative, microaerophilic bacterium that can inhabit various areas of the stomach and duodenum. It causes a chronic low-level inflammation of the stomach lining and is strongly linked to the development of duodenal and gastric ulcers and stomach cancer. Over 80% of individuals infected with the bacterium are asymptomatic. More than 50% of the world's population harbour H. pylori in their upper gastrointestinal tract. Approximately 10-20% of those colonized by H. pylori will ultimately develop gastric and duodenal ulcers. H. pyloriinfection is also associated with a 1-2% lifetime risk of stomach cancer and a less than 1% risk of gastric MALT lymphoma.

INTENDED USE

Kit H. pylori Real-TM is a test for the qualitative detection of Helicobacter pylori in the biopsy sample of stomach mucous membrane, sputum, feces and other biological materials.

PRINCIPLE OF ASSAY

Kit H.pylori Real-TM is based on two major processes: isolation of DNA from specimens and Real Time amplification. H.pylori DNA is extracted from the specimens, amplified using Real[1]Time amplification and detected fluorescent reporter dye probes specific for H.pylori DNA and Internal Control. Internal Control (IC) serves as an amplification control for each individually processed specimen and to identify possible reaction inhibition. IC is detected in a channel other than the H.pylori .