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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).

Instruction for use (PDF)
Product-Flyer (PDF)

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).

Instruction for use (PDF)
Product-Flyer (PDF)

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.

Instruction for use (PDF)
Product-Flyer (PDF)

ART. CODE NAME SIZE CE MARKED
BM-HPY-2D BioNexia H. Pylori Stool test  20 tests YES


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HHC News - NOV 2011

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