Helicobacter pylori IgM ELISA kit is an enzyme immunassay for the in-vitro diagnostic qualitative and quantitative determination of IgM antibodies against Helicobacter pylori in human serum. Helicobacter pylori IgM ELISA kit is a solid phase enzyme-linked immunosorbent assay (ELISA) based on the sandwich principle. The wells of this helicobacter pylori IgM ELISA kit are coated with antigen. Specific antibodies of the sample binding to the antigen coated wells are detected by a secondary enzyme conjugated antibody (E-Ab) specific for human IgM. After the substrate reaction the intensity of the colour developed is proportional to the amount of IgM-specific antibodies detected. Results of samples can be determined directly using the standard curve.
The helicobacter pylori IgM ELISA kit is shipped at ambient temperature and should be stored at 2-8°C. Keep away from heat or direct sunlight. The storage and stability of specimen and prepared reagents is stated in the protocol insert. The microtiter strips of this helicobacter pylori IgM ELISA kit are stable up to the expiry date of the kit in the broken, but tightly closed bag when stored at 2–8°C.
The helicobacter pylori IgM ELISA kit test results are only valid if the test has been performed following the instructions. Moreover the user must strictly adhere to the rules of GLP (Good Laboratory Practice) or other applicable standards/laws. All standards used with this helicobacter pylori IgM ELISA kit must be found within the acceptable ranges as stated on the QC Certificate. If the criteria are not met, the run is not valid and should be repeated. Each laboratory should use known samples as further controls. In case of any deviation the following technical issues should be proven: Expiration dates of (prepared) reagents, storage conditions, pipettes, devices, incubation conditions and washing methods. It is recommended to participate at appropriate quality assessment trials.
Helicobacter pylori is a 2.5 - 3 μm long twisted or helical gram-negative germ responsible for 80 - 90% of Bgastritis cases and suspected to a major cofactor for the development of gastric and duodenal ulcers. The classical detection methods of Helicobacter pylori like culturing from mucous membrane biopsies or an urease test are only successful in case of a relative high germ count and require an identification directly after the biopsy. Indirect immunofluorescence (IIF) is also used for the detection Helicobacter pylori infection. The colonisation of the gastric and duodenal mucous membranes with Helicobacter pylori can also be detected serologically using an enzyme immunoassay (ELISA) or by performing a Western Blot. Patients with confirmed exposition to Helicobacter pylori often show a positive serological result. Since antibodies persist for a longer time after a Helicobacter pylori infection seropositive individuals are also found in symptom-free patients. The number of seropositive values rises with age. Using the ELISA and the detection of IgA and IgG antibodies against specific proteins of Helicobacter pylori by Western Blotting it is possible to diagnose an acute infection with Helicobacter pylori, even if no germs can be found.
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