Detecting infections by acid-resistant microorganisms, particularly for diagnosing Helicobacter pylori, comprises immunochromatographic detection of antigen in feces

摘要

Detecting infection by an acid-resistant microorganism (A), in a mammal, comprises using immunochromatography. Detecting infection by an acid-resistant microorganism (A), in a mammal, comprises (a) preparing an immunochromatographic test strip having a sample application zone (I); (b) applying a fecal sample, containing an antigen (Ag) of (A) to (I); (c) incubating the sample with: (i) a first receptor (R1) to form a complex with Ag; or (ii) at least two different R1 to form a three-part complex with Ag, where R1 are specific for an Ag which, after passage through the intestines, at least in some mammals, retains a native (or corresponding) structure against which the mammal produces antibodies (when immunized or infected with (A), or its extracts, lysates or derived proteins (or fragments) or synthetic peptides); (d) immobilizing a second receptor (R2), able to bind to the complex formed between Ag and R1 to an analytical region; (e) transporting the first complex; (f) forming a second complex with R2 in the analytical region; and (g) detecting the complex. Independent claims are also included for the following: (1) an immunochromatography test device, especially for the new process, that comprises (I), an incubation system, an analytical region and a system for transporting the Ag-R1 complex; (2) monoclonal antibodies (MAb), their fragments or derivatives, that have a variable region comprising at least one of 24 specified CDRs (complementarity-determining regions), given in the specification; (3) an aptamer (i) that binds specifically to the same epitope as MAb; (4) an epitope (ii) that binds specifically to MAb or (i); (5) an antibody, or its fragments or derivatives, that bind specifically to (ii); and (6) a kit containing at least one test device of (1).