Intended Use
Quantitative and qualitative tests for detection of human antibodies in serum or plasma against Helicobacter pylori.
Storage
1. Microtiter strips (antigen). After opening at 2-8°C in closed aluminum bag with desiccant, 4 weeks. Strips which are not used must be stored in the press-seal bag of aluminum compound foil under dry and airtight conditions!
2. Control sera / standard sera. After opening at 2-8°C, until expiry date; 24 months from date of production
3. Conjugate. Ready-to-use solution, at 2-8°C, until expiry date 28 months from date of production. Avoid contamination (sterile tips!)
4. Dilution buffer. After opening at 2-8°C, 24 months. Discard cloudy solutions! Unopened, until expiry date; 36 months from date of production
5. Washing solution. Concentrate after opening at 2-8°C, until expiry date. Working dilution at 2-8°C, 2 weeks. Working dilution at room temperature, 1 week. Bottles used for the working dilution should be cleaned regularly, discard cloudy solutions.
6. Substrate. Ready-to-use solution at 2-8°C, protected from light! Until expiry date 24 months from date of production. Avoid contamination (sterile tips!) Discard when solution turns yellow (extinction against distilled water. > 0.25).
7. Stopping solution. After opening at room temperature. Until expiry date.
General Description
Helicobacter is a gram negative, spirally shaped, flagellated bacterium. Microbiological identification of H.pylori is made by positive urease, catalase and oxidase tests as well as missing hippurate hydrolysis and nitrate reductase support. Helicobacter pylori is specific for humans. Other helicobacter species are found in mammals such as cats, dogs, pigs, and mice. H.pylori isolates may differ phenotypically in expression/non-expression of vacuolating cytotoxin (VacA) and a second toxin which is encoded by cytotoxin-associated gene (CagA). Virulent (Type I) and non-virulent (Type II) helicobacter strains can be distinguished by these phenotypical differences. VacA and CagA expressing Type I H. pylori strains have been associated with duodenal ulcers. Transmission of Helicobacter pylori to humans is still not well understood. Oral-oral and oral-fecal transmission have been suggested.
Citations
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Naja, F; Nasreddine, L; et al. Association of H. pylori Infection with Insulin Resistance and Metabolic Syndrome Among Lebanese Adults. HELICOBACTER 17:444-451(2012).
Akguc, M; Karatayli, E; et al. Production of a Recombinant CagA Protein for the Detection of Helicobacter pylori CagA Antibodies. MIKROBIYOLOJI BULTENI 48:402-412(2014).