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.
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.
This kit is designed to detect helicobacter pylori through visual
interpretation of the color development in the internal strip based
on the specific The membrane was immobilized with
antibodies-specific on the test well (T) and corresponding
antibodies on the control well(C) .
During testing, the specimen is added to the sample region (S) and
reacts with anti-H. pylori antibodies conjugated to colored
particles and precoated onto the sample pad of the test. Then, the
mixture migrates through the membrane by capillary effect and
interacts with reagents on the membrane. If there is sufficient H.
pylori antigens in the specimen, a colored band will form at the
test well (T) of the membrane, and this colored band indicates a
positive result, while its absence indicates a negative result. A
colored band at the control well(C) serves as a procedural control,
indicating that the proper volume of specimen has been added and
membrane wicking has occurred.
Individual packed test cassette
Each cassette contains a strip with colored conjugates and reactive
reagents precoated at the corresponding position.
Specimen tube with extracting solution
Main Ingredients: NaCl , EDTA, sodium azide and purified Water
For operating instruction
MATERIALS REQUIRED BUT NOT PROVIDED
STORAGE AND VALIDITY
· The kit should be stored at 2-30°C in a cool and dry place,
protected from light
· The validity duration is 12 months
· Do not freeze.
· Do not use after the expiration date indicated on the package.
· Sufficient specimen should be collected and extracted.
· No age limitation to specimen providers
· No limitation to specimen collection time.
· Perform testing immediately after specimen collection. Do not
leave specimens at room temperature for prolonged periods.
Specimens may be stored at 2-8°C for up to 72 hours or frozen at
-10°C for long- term storage.
· Avoiding repeated freezing and unfreezing. Fresh specimen is
· Specimen can not be used for test once stored more than 72 hours
at 2-8°C and repeated freezing and unfreezing more than three
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
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