HP H.Pylori Rapid Test Cassette Immunochromatography (Feces
Specimen) CE ISO
【H. pylori INTRODUCTION】
Helicobacter pylori (also known as Campylobacter pylori) is a
spiral-shaped with a typical flagellum, Gram negative bacteria,
infecting gastric mucosa. It 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,
so as to be classified as carcinogen agent type I.
Many H. pylori strains have been isolated: among them, the strain
expressing CagA antigen is strongly immunogenic and, according to
this, it is of utmost clinical importance because it is associated
to the cytotoxic factor. It is widely reported in many literature
articles that, in infected patients showing antibodies against CagA
gene product, the risk of gastric cancer is up to five times higher
than the reference group infected with a CagA negative bacterial
strain.
At present several invasive and non-invasive approaches are
available to detect this infection state. Invasive methodologies
requires endoscopy of the gastric mucosa with a histologic,
cultural and urease investigation, which are cost-effective and
require long times to come to a correct final diagnosis.
Alternatively, non-invasive methods are available such as Breath
Test, which is extremely complicated and not highly selective, or
classical ELISA and immunoblotting assays.
【H. pylori Ag RAPID TEST INTENDED USE】
The H. pylori Antigen Rapid Test (Feces) is a rapid visual
immunoassay for the qualitative presumptive detection of
Helicobacter pylori antigens in human fecal specimens. This kit is
intended to be used as an aid in the diagnosis of H. pylori
infection.
【MAIN CONTENTS】
One pouch containing a rapid test cassette with desiccant.
Specimens dilution tube with buffer
Package insert
【PRECAUTIONS】
For professional in vitro diagnostic use only.
Do not use after the expiration date indicated on the package. Do
not use the test if the foil pouch
is damaged. Do not reuse tests.
Used testing materials should be discarded according to local
regulations
【H. pylori Ag DIRECTION OF USE】
Bring tests, specimens, buffer and/or controls to room temperature
(15-30°C) before use.
1. Specimen collection and pre-treatment:
1) Best results will be obtained if the assay is performed within 6
hours after collection.
2) Unscrew and remove the dilution tube applicator stick. Be
careful not to spill or spatter solution from the tube. Collect specimens by inserting the
applicator stick into at least 3 different sites of the feces to collect approximately 50 mg of
feces (equivalent to 1/4 of a pea).
3) Place the applicator stick back into the tube and screw the cap
tightly. Be careful not to break
the tip of the dilution tube.
4) Shake the specimen collection tube vigorously to mix the
specimen and the extraction buffer.
2. Testing
1) Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control identification. To obtain a best result,
the assay should be performed within one hour.
2) Using a piece of tissue paper, break the tip of the dilution
tube. Hold the tube vertically and dispense 2-3 (80-100 μL) drops of solution into the specimen well
(S) of the test device. Avoid trapping air bubbles in the specimen well (S), and do not
drop any solution in
observation window. As the test begins to work, you will see color move across the
membrane.
3. Wait for the colored band(s) to appear. The result should be
read in 15 minutes.
Note: If the specimen does not migrate (presence of particles),
centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of
supernatant, dispense into the specimen well(S) of a new test device and start afresh following the
instructions mentioned above.
【INTERPRETATION OF RESULTS】
POSITIVE:
The presence of two lines as control line (C) and test line (T)
within the result window indicates a positive result.
NEGATIVE:
The presence of only control line (C) within the result window
indicates a negative result.
INVALID:
If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some causes of invalid results are because of
not following the directions correctly or the test may have deteriorated beyond the expiration
date. It is recommended that the specimen be re-tested using a new test.
