Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving antigen-antibody binding – specific binding protein...
Patent
1995-04-26
2000-05-30
Housel, James C.
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving antigen-antibody binding, specific binding protein...
4242341, G01N 33554
Patent
active
060689854
DESCRIPTION:
BRIEF SUMMARY
The present invention relates generally to a method and kit which permit the rapid in vitro detection of Helicobacter pylori infection in mammals. More particularly, the present invention contemplates a method for the detection of IgG antibodies against H. pyloni in mucous secretions and thereby provides a means to monitor contemporary infection by the microbe in mammals.
Gut infections in mammals, and in particular humans, stimulate an immune response in mucous secretions, such as saliva, through activation of the common mucosal immune system. This response often initially parallels an antibody response in serum although is generally characterised by the presence of IgA antibodies. However, the immune response in secretion, including saliva, rapidly diminishes following elimination of the antigen (eg bacteria or virus) from the body. Accordingly, the presence of antibody in mucous secretions reflects current, ie contemporary, infection. In the case of a microbial infection, for example, antibodies in mucous secretions, hereinafter referred to as secretious antibodies, reflect the current status of colonisation of the microbe, such as in the gut, and thus is a useful monitor of contemporary infection. Serum antibody, on the other hand, persists for some time after the microbe is eliminated from the body. A positive serum antibody test, therefore, reflects both past and present exposure to antigen which is less helpful to the clinician. A positive secretious antibody test, on the other hand, indicates present or contemporary infection by the microbe.
The present invention arose following an investigation into Helicobacter pylori (also known as Campylobacter pylori) infection in the gut of mammals. The diagnosis of H. pylori infection can be made by microscopy, microbiological culture or urease detection in gastric mucosal biopsies, urea breath test or by the presence of specific antibodies in serum ELISAs. It might be predicted that H. pylori infection, being an infection of the gastric mucosa, would elicit an IgA antibody response in gastric secretion. However during work prior to the present invention, it was discovered that H. pylori-specific antibody in mucous secretions is of the IgG class and not IgA as might have been expected. Little IgA antibody, if any, is detected. Accordingly, AU-A-9067676 is directed to the detection of IgG in mucous secretion specific to H. pylori antigen and thereby provides a means of monitoring current, ie contemporary, infection by that microorganism in mammals. The corresponding academic publication is Witt et al, Frontiers in Mucosal Immunology 1 693-696 (1991).
The presence of IgG antibodies in the saliva of Campylobacter pylori positive patients has received some attention in the proceedings of the Annual Meetings of the American Gastroenterological Association. After the disclosure by Czinn et al of the presence of such antibodies in the 1989 proceedings, Larsen et al concluded in the May 1991 proceedings that salivary IgG levels are a practical, non-invasive marker of therapeutic response during a course of antibiotic therapy. In the April 1992 proceedings, Landes et al confirmed earlier observations and observed that measurement of salivary IgG to Helicobacter pylori is a simple, non-invasive test for detecting H. pylori positive patients, especially in widespread or paediatric populations where other tests are not practical.
It is clear from the above that there is widespread interest in, and clinical potential for, a salivary IgG based diagnostic test for H. pylori. Equally, it is clear that such a test must be reliable as well as convenient. Invasive techniques are known (eg from U.S. Pat. No. 4,882,271, Schaber et al, J. Clin. Microbiol. 27(2) 327-330 (1989), Loffeld et al, The Lancet, May 27, 1989, 1182-1185 and Evans et al, Gastroenterology 96 1004-1008 (1989)) and established (eg the CLOTEST.TM. kit which is available from Delta West Ltd, Perth, Western Australia and which detects the presence of urease in biopsy samples). A non-invasive test must rival the r
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Clancy Robert Llewellyn
Cripps Allan
Stiel Daniel
Witt Campbell
Housel James C.
Portner Ginny Allen
Provalis UK Limited
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