H.Pylori Ag Stool Rapid Test

INTENDED USE

The Helicobacter-Pylori antigen rapid test kit (stool) is a rapid visual immunoassay for the qualitative detection of helicobacter pylori antigen in human stool specimens. This kit is used as an aid in the diagnosis of H. pylori infection.

INTRODUCTION

Helicobacter pylori (also known as Campylobacter pylori) as a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori to causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma.

The epidemiologic study shows that more than 50% of the world's population is infected by H. pylori strains. Infection is more prevalent in developing countries. The lowest infection rate is 20%, and the highest infection rate can be 90% in developing countries. H. pylori strains is the major reason to cause chronic gastritis and gastric ulcers, 80%-90% chronic gastritis patients and 95%-100% gastric ulcers patients are infected by H. pylori strains. So the detection and treatment of H. pylori strains infection is very important.

At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays. This Kit belongs to non-invasive approach.

PROCEDURE

Read the entire procedure carefully prior to testing. Keep test kit and specimen at room temperature (15-30°C) before use.

1. Unscrew the specimen tube with extracting solution, collect specimen by inserting the collection stick into the stool to collect the specimen with diameter approximate to 5mm (equivalent to 1/4 of a green bean).
2. Put the collection stick back into the tube carefully and screw the cap tightly.
3. Press the bottom of specimen tube strongly; fully shake to mix the specimen and the extraction buffer. Then keep the specimen stationary in two minutes before use.
4. Take the test cassette out of its sealed pouch, and place it on a clean, dry and flat surface.
5. Unscrew the top cap of extracting tube. Hold the tube vertically and dispense 2-3 drops of solution into the sample region (S) of the test cassette. The unsealed test cassette should be performed within one hour.
6. Wait for the colored band(s) to appear. The result should be read right after 15minutes. Do not interpret the result after 20 minutes.