H.Pylori IgG/IgM Ab Rapid Test

CE APPROVED

  • First of its kind H.Pylori IgG/IgM Antibody Rapid Test

  • Easy to use, result in minutes and needs to special equipment

  • Simultaneous and differential qualitative detection of H. pylori IgG & IgM antibodies in serum, plasma or whole blood samples

  • The test may also be used for monitoring the response to treatment of H. pylori. A significant decrease in IgM in respect to the titer detected during the active infection is useful to validate the therapy.

Intended Use:

Biocan TELL ME FAST H. Pylori IgG/IgM Test is a rapid chromatographic immunoassay for the simultaneous and differential qualitative detection of H. pylori IgG & IgM antibodies in serum, plasma or whole blood samples. This is a screening test and results should be confirmed with other qualifying assays.

Summary and Principle of the assay:

Helicobacter pylori (H. pylori) was initially isolated by Warren and Marshall from biopsy samples taken from patients suffering from active chronic gastritis. In fact, it is now clear that H. pylori is the principle etiologic agent in type B gastritis (chronic active antral gastritis) pathology for which it appears to be the triggering and perhaps aggravating factor. Increasing data are being accumulated regarding the fundamental role of H. pylori in active chronic gastritis, in gastric ulcer and in duodenal ulcer and its close correlation with gastric lesions. H. pylori is isolated in culture medium and examined by microscopy after staining or is detected by urease test. Both these techniques are lengthy to implement and their sensitivity and specificity have yet to be demonstrated. The immunochromatographic techniques for the detection of IgG & IgM antibodies specific to H. pylori has substantially resolved these problems, ensuring a serological monitoring in a very short space of time using simple, highly specific technology without recourse to invasive techniques. Biocan H. pylori IgG/IgM rapid test can be utilized as a rapid screening process for large populations of patients and highly indicated in the early diagnosis of H. pylori infection as the immune response can often precede clinical manifestations of disease. From a diagnostic point of view, a high serum, plasma or whole blood level specific antibodies against H. pylori must be interpreted as an indication of type B asymptomatic gastritis. H. pylori is detectable in nearly 100% of adult patients with duodenal ulcer and about 80% of patients with gastric ulcer. An association between H. pylori and gastric cancer is confirmed. In developing countries, where most children become infected by the age of 10, gastric cancer rates are very high. In the USA and other developed countries, standards of hygiene and the increasing socioeconomic status of the population have reduced the incidence of infection, and in parallel, the rates of peptic ulcers and gastric cancer have declined. There is excellent correlation between the clinical presentation of gastritis, the presence of H. pylori in the stomach and elevated serum H. pylori IgG antibody. ELISA sensitivity and specificity are 90%, and the predictive value of a negative result for is very high. H. pylori- specific IgG antibody falls significantly after successful antibacterial therapy. Eradication of H. pylori is associated with a significant reduction in duodenal ulcer recurrence. H. pylori strains are classified into two broad groups - those that express both VacA and CagA (type I) and those that produce neither (type II).Type I strains are predominate in patients with ulcers and cancer. Up to 50% of adults is infected with H. pylori, but most of them are asymptotic and will not develop ulcer. The reason is they are infected with type II. 80-100% of patients with duodenal ulcer disease produce CagA antibodies against a 128 kd antigen compared with 60-63% of H. pylori-infected persons with gastritis only, indicating that serologic responses to the 128 kd protein are more prevalent among H. pylori-infected persons with duodenal ulcers than infected persons without peptic ulceration. In H. pylori-infected patients who develop gastric cancer, serum IgG against CagA 94% sensitive and 93% specific, indicating that detection of antibodies to CagA is useful marker for diagnosis of duodenal ulcer and gastric cancer. A high IgM titer specific to Helicobacter pylori may indicate active infection or, vice-versa, the positive response to the test may confirm the diagnosis of gastritis or peptic ulcers based on patient history, clinical symptoms and physical examination. The test may also be used for monitoring the response to treatment of H. pylori. A significant decrease in IgM in respect to the titer detected during the active infection is useful to validate the therapy. A definitive diagnosis should be given only when the clinical signs and symptoms of the patient are compatible.    

 

H.Pylori Antigen Rapid Test

CE APPROVED

 

H.Pylori Antibody Rapid Test

CE APPROVED

 

S.Typhi/Para Typhi ABC (Typhoid) Antigen Rapid Test

A rapid one step test for qualitative detection and differentiation of Salmonella typhi and paratyphi A,B,C antigens in human stool/serum/plasma. For professional in vitro diagnostic use only.

Intended Use:

TELL ME FAST Salmonella typhi/paratyphi A,B,C Antigen is a rapid chromatographic immunoassay for qualitative detection and differentiation of Salmonella typhi and paratyphi A, B & C antigens in human stool, serum or plasma. This test is intended for professional use and is a preliminary screening test and final diagnosis should be based after examination with other assays.  

Summary and Principle:

Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhus, and was observed by Eberth (1880) in the mesenteric nodes and spleen of fatal cases of typhoid fever. It is common in developing countries where it affects about 12.5 million persons annually. Paratyphoid fever is caused by any of three strains of Salmonella paratyphoid: S. Paratyphi A; S. schottmuelleri (also called S. Paratyphi B); or S. hirschfeldii (also called S. Paratyphi C). It starts when the bacterium S. Paratyphi A, B or C is passed from another person due to bad hygiene such as not washing one's hands after using the restroom. Eventually the bacterium passes down to the bowel, then penetrates the intestinal mucosa (lining) to the underlying tissue. If the immune system is unable to stop the infection here, the bacterium will multiply and then spread to the bloodstream, after which the first signs of disease are observed in the form of fever. The bacterium penetrates further to the bone marrow, liver and bile ducts, from which bacteria are excreted into the bowel contents. In the second phase of the disease, the bacterium penetrates the immune tissue of the small intestine, and the initial symptoms of small-bowel movements begin.The infection is acquired typically by ingestion. On reaching the gut, the bacilli attach themselves to the epithelial cells of the intestinal villi and penetrate the lamina and submucosa. They are then phagocytosed there by polymorphs and mesenteric lymph nodes, where they multiply and, via the thoracic duct, enter the blood stream. A transient bacteremia follows, during which the bacilli are seeded in the liver, gall bladder, spleen, bone marrow, lymph nodes, and kidneys, where further multiplication takes place. Towards the end of the incubation period, there occurs a massive bacteremia from these sites, heralding the onset of the clinical symptoms. Serovar paratyphi A is the second most prevalent cause of Typhoid. Paratyphi A and typhi cause a similar illness, with relapsing fever. The diagnosis of typhoid and Paratyphoid consists of isolation of the bacilli and the demonstration of antibodies. The isolation of the bacilli is very time consuming and antibody detection is not very specific. Other tests include the Widal reaction. Biocan has developed a test that takes only 10-20 minutes and requires serum, plasma or a small amount of stool to perform.  It is the easiest and most specific method for detecting S. typhi and paratyphi in fection. The test employs a combination of monoclonal antibody/colloidal gold dye conjugate and a polyclonal antibody immobilized on the solid phase. This will selectively identify the S. typhi and paratyphi A,B,C antigens associated Salmonella typhi (typhoid) and salmonella    paratyphi (paratyphoid) infections with a high degree of sensitivity and specificity.

 

S.Typhi IgG/IgM Ab & S.Typhi/Para Typhi ABC Ag Combo Rapid Test

CE APPROVED

A rapid, one step test for the simultaneous & qualitative detection of Salmonella typhi and paratyphi ABC antigens & S.Typhi IgG/IgM Antibodies in stool/serum/plasma. For professional in vitro diagnostic use only.

Intended Use:

TELL ME FAST Salmonella typhi/paratyphi A,B,C Antigens & S.Typhi IgG/IgM Antibody Combo Test Device is a rapid chromatographic immunoassay for the simultaneous & qualitative detection of Salmonella typhi and paratyphi ABC antigens in stool/serum/plasma and S.Typhi IgG/IgM Antibodies in serum/plasma/whole blood.

Summary and Principle:

Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhus, and was observed by Eberth (1880) in the mesenteric nodes and spleen of fatal cases of typhoid fever. It is common in developing countries where it affects about 12.5 million persons annually. The infection is acquired typically by ingestion. On reaching the gut, the bacilli attach themselves to the epithelial cells of the intestinal villi and penetrate the lamina and submucosa. They are then phagocytosed there by polymorphs and mesenteric lymph nodes, where they multiply and, via the thoracic duct, enter the blood stream. A transient bacteremia follows, during which the bacilli are seeded in the liver, gall bladder, spleen, bone marrow, lymph nodes, and kidneys, where further multiplication takes place. Towards the end of the incubation period, there occurs a massive bacteremia from these sites, heralding the onset of the clinical symptoms. Serovar paratyphi A is the second most prevalent cause of Typhoid. Paratyphi A and typhi cause a similar illness, with relapsing fever. The diagnosis of typhoid and Paratyphoid consists of isolation of the bacilli and the demonstration of antibodies. The isolation of the bacilli is very time consuming and antibody detection is not very specific. Other tests include the Widal reaction. Biocan has developed a test that takes only 10-20 minutes and requires serum, plasma or a small amount of stool to perform.  It is the easiest and most specific method for detecting S. typhi and paratyphi infection. The test employs a combination of monoclonal antibody/colloidal gold dye conjugate and a polyclonal antibody immobilized on the solid phase. This will selectively identify the S. typhi and paratyphi A,B,C antigens associated Salmonella typhi (typhoid) and salmonella paratyphi (paratyphoid) infections with a high degree of sensitivity and specificity. TELL ME FAST S.Typhi IgG/IgM Ab & Salmonella typhi/paratyphi ABC Ag Test Device is a qualitative, lateral flow immunoassay for the detection of S.typhi IgG/IgM Ab & Salmonella typhi and paratyphi in stool/serum/plasma/whole blood. One side of the the membrane is pre-coated with anti-salmonella antibodies on the test line region of the strip.  During testing, the stool/serum/plasma specimen reacts with the particle coated with anti-Salmonella antibody. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-Salmonella antibodies on the membrane and generate a colored line. The presence of this colored line in the test region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. On the right side of the test device first a specimen is dispensed into the sample well of the test device.  If IgG or IgM antibodies to S. typhi are present in the specimen they will bind to the colloidal gold-antigen conjugate and travel up the membrane chromatographically.  The antibody-Antigen-colloidal gold complex will then bind to the immobilized anti-Human IgG and/or anti-Human IgM coated on the membrane.  This will cause pale to dark colored lines to form at the IgG or IgM test region and can be seen in the results window. The intensity of the lines will vary depending upon the amount of antibody present in the sample. The appearance of a colored line in a specific test region should be considered as positive for that particular antibody (IgG and/or IgM). To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and proper membrane wicking has occurred.

 

S.Typhi IgG/IgM Ab (Typhoid) Rapid Test

A rapid, one step test for the simultaneous & qualitative detection of Salmonella typhi and paratyphi ABC antigens & S.Typhi IgG/IgM Antibodies in stool/serum/plasma. For professional in vitro diagnostic use only.

Intended Use:

Tell Me Fast Typhoid Test Device is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Salmonella typhi and paratyphi in serum, plasma or whole blood. This test is intended for professional use and is a preliminary screening test and final diagnosis should be based after examination with other assays.  

Summary and Principle:

Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhus, and was observed by Eberth (1880) in the mesenteric nodes and spleen of fatal cases of typhoid fever. It is common in developing countries where it affects about 12.5 million persons annually. The infection is acquired typically by ingestion. On reaching the gut, the bacilli attach themselves to the epithelial cells of the intestinal villi and penetrate the lamina and submucosa. They are then phagocytosed there by polymorphs and mesenteric lymph nodes, where they multiply and, via the thoracic duct, enter the blood stream. A transient bacteremia follows, during which the bacilli are seeded in the liver, gall bladder, spleen, bone marrow, lymph nodes, and kidneys, where further multiplication takes place. Towards the end of the incubation period, there occurs a massive bacteremia from these sites, heralding the onset of the clinical symptoms. The diagnosis of typhoid consists of isolation of the bacilli and the demonstration of antibodies. The isolation of the bacilli is very time consuming and antibody detection is not very specific. Other tests include the Widal reaction. Biocan has developed a test that takes only 10-30 minutes and requires only a small amount of serum or plasma to perform. Biocan Tell Me Fast Salmonella typhi IgG/IgM Test Device (Serum/Plasma) is a qualitative test for the detection of IgG and IgM antibodies to S. typhi and paratyphi in human serum, plasma or whole blood. The test provides a differential detection of anti-S. typhi-IgG and anti-S. typhi -IgM antibodies and can be used for the presumptive distinction between a current, latent and/or carrier S. typhi infection. Serum or plasma samples may be used with this test. First a specimen is dispensed into the sample well of the test device.  If IgG or IgM antibodies to S. typhi are present in the specimen they will bind to the colloidal gold-antigen conjugate and travel up the membrane chromatographically.  The antibody-Antigen-colloidal gold complex will then bind to the immobilized anti-Human IgG and/or anti-Human IgM coated on the membrane.  This will cause pale to dark colored lines to form at the IgG or IgM test region and can be seen in the results window. The intensity of the lines will vary depending upon the amount of antibody present in the sample. The appearance of a colored line in a specific test region should be considered as positive for that particular antibody (IgG and/or IgM). To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and proper membrane wicking has occurred.

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