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| ENTERICS AND GASTRO INTESTINAL |
H. Pylori
Antigen Test
The H.pylori antigen test is an in vitro qualitative
immunochromatographic assay for the rapid detection of Helicobacter
pylori antigens in human stool specimen. The test results are intended
to aid in the diagnosis of H. pylori infection, to monitor the
effectiveness of therapeutic treatment and to confirm the eradication
of H. pylori in peptic ulcer patients.
Fecal Occult Blood(FOB) Test
The Fecal Occult Blood test is a qualitative test that detects human
hemoglobin in human fecal specimens. The test is a visual one step,
in-vitro assay. It is intended for professional use to help diagnose
gastrointestinal bleeding. |
| Product
Name |
Cat. No. |
Specimen |
Fomat |
Packaging |
Details |
CE Marked |
|
H.
Pylori Antibody Test
|
71024
|
Whole Blood/Serum/Plasma
|
Cassette
|
25 Tests/box
|
pdf. file |
NO |
|
H.
Pylori Antibody Test
|
71046
|
Serum/Plasma
|
Cassette
|
25 Tests/box
|
pdf. file |
YES |
|
H.
Pylori Antigen Test
|
71020
|
Feces
|
Cassette
|
25 Tests/box
|
pdf. file |
YES |
|
Fecal
Occult Blood(FOB) Test
|
72006
|
Feces
|
Strip
|
100 Tests/box
|
pdf. file |
NO |
|
Fecal
Occult Blood(FOB) Test
|
72001
|
Feces
|
Cassette
|
25 Tests/box
|
pdf. file |
NO |
|
The
BioNexia® FOBplus is a visual
immunochromatographic quick test for the qualitative detection of human
hemoglobin in stool samples. The test is only intended for professional
in vitro diagnostic use.

The immunological Bionexia® FOB quick test is
based on a immunochromatographic method, in which only human hemoglobin
is recognized through specifi c antibody reactions.
The hemoglobin contained in the stool sample reacts with specifi c
monoclonal antibodies that are attached to gold particles. This complex
is distributed on the membrane and reaches the test band (T) on which
the anti-hemoglobin is present. In the case of a positive result, the
molecules from the stool sample loaded with gold-marked antibodies
attach to the test band (T) and are visible by means of a pink/red
coloration.
In the case of a negative result, there are no hemoglobin molecules
that can attach to the test band (T) as complexes and therefore, there
can also be no coloration of the test band (T).
|
| ART. CODE |
NAME |
SIZE |
CE
MARKED |
| BM-FOB-1D |
BioNexia®
FOBplus |
25 cassettes |
YES |
|
BioNexia®
Hb/Hp-Complex is a visual, immunochromatography dual quick
double test for the qualitative detection of human hemoglobin in stool
samples.
The immunological Bionexia® Hb/Hp complex is
based on a immunochromatographic method, in which both Hb and Hb/Hp
complexes are specifi cally recognized through specifi c antibody
reactions.
For Hb:
The hemoglobin contained in the stool sample reacts with specifi c
monoclonal antibodies that are attached to gold particles. This complex
is distributed on the membrane and reaches the test band (T) on which
the anti-hemoglobin is present.
For Hb/Hp:
An antibody attaches to hemoglobin and
another antibody attaches to the haptoglobin. The result is that
specifi c Hb/Hp complexes are measures and there is no cross-reactivity
with hemoglobin. In the case of a positive result, the molecules from
the stool sample loaded with gold-marked antibodies attach to the test
band (T) and are visible by means of a pink/red coloration.
In the case of a negative result, there are no hemoglobin molecules
that can attach to the test band (T) as complexes and therefore, there
can also be no coloration of the test band (T).
|
| ART.
CODE |
NAME |
SIZE |
CE MARKED |
| BM-FOB-2D |
BioNexia®
Hb/Hp Complex |
20 cassettes |
YES |
|
|
The BioNexia®
H. pylori Stool Card is an immunochromatographic screening
assay for the qualitative detection of Helicobacter pylori antigen in
stool samples.
Helicobacter pylori (also formerly known as Campylobacter pylori) is a
spiral-shaped, Gram-negative bacterium with typical flagella.
It is capable of infecting the gastric mucosa. It causes several
gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and
duodenal ulcer, active gastritis and might even increase the risk of
stomach adenocarcinoma, so that it has been classified as carcinogenic
agent type I.
Various H. pylori strains have been isolated that differ in their
virulence. Strains exhibiting a high virulence are generally
characterized by the possession of the vacuolating cytotoxin (Vac A)
and the so called cytotoxin associated genes cag pathogenicity island.
These factors seem to be necessary for an effective infiltration of the
gastric mucosa and seem to be associated with the persistence of the
infection. They also contribute to sudden inflammatory responses,
ulceration (gastric and duodenal ulcer), allergic episodes, and
decrease of therapy efficacy.
Especially the CagA protein that is strongly immunogenic and is
secreted into the gastric cells by a special mechanism is of special
clinical importance. It has been widely reported in many literature
articles that infected patients showing antibodies against the CagA
gene product have a five times increased risk of developing gastric
cancer if compared to a reference group infected with a CagA negative
bacterial strain. At present several invasive and non-invasive
approaches are available to detect the infection state.
Invasive methodologies require endoscopy of the gastric mucosa with a
histological, cultural and urease investigation. These examinations are
expensive and time-consuming.
Alternatively, non-invasive methods are available such as Breath Tests
with isotope labelled urea, which are complicated and cost-intensive,
or classical ELISA or immunoblotting assays.
The BioNexia H. pylori
assay is an immunological rapid assay that takes advantage of a highly
specific antibody/antigen reaction to detect bacterial protein of H.
pylori (antigen) in stool samples.
|
| ART.
CODE |
NAME |
SIZE |
CE MARKED |
| BM-HPY-2D |
BioNexia
H. Pylori Stool test |
20 tests |
YES |
|
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Do you have any other question? Contact us and we will help you.
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The .pdf version of this page
is available in our
our products
page.
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