Method for the detection and identification of a variant <i>C. difficile </i>strain in a sample

摘要

The method for detecting and identifying a variant C. difficile strain in a sample is characterized by the following steps: (a) obtaining a sample of excreta or tissue from a human or animal patient body; (b) bringing the sample into contact with at least one antibody from each of at least three of the antibody groups group I, group II, group III, group IV, group V and group VI; (c) detecting the antibody reaction and constructing the reaction pattern; (d) comparing the reaction pattern obtained in (c) with reference patterns from known C. difficile strains and C. difficile strains the presence of which is to be tested in the investigation test; (e) assessing the agreement between the reaction pattern obtained in (c) and the reference pattern as indicative of the presence of the C. difficile strain of the reference pattern concerned in the sample.

主权项

1. A method for detecting and identifying a variant C. difficile strain in a sample, comprising:
(a) obtaining a sample of excreta or tissue from a body; (b) bringing the sample into contact with at least one antibody from each of at least three of antibody groups group I, group II, group III, group IV, group V and group VI to detect a positive or a negative reaction with the sample, wherein:
group I consists of pan-TcdB antibody TGC 35 (DSM ACC 2918), pan-TcdB antibody 2CV (DSM ACC 2321) and/or antibodies which bind to the same binding sites on purified TcdB protein from all pathogenic C. difficile strains as said antibody TGC 35 and/or 2CV;group II consist of antibody TGC 23 (DSM ACC 2917) and/or antibodies which bind to the same binding sites on purified toxins TcdB-10463 and TcdB-017 as said antibody TGC 23group III consists of antibody TGC 41 (DSM ACC 2919) and/or antibodies which bind to the same binding sites on purified toxin TcdB-10463 as said antibody TGC 41;group IV consists of antibody TGC 16 (DSM ACC 2915) and/or antibodies which bind to the same binding sites on purified toxins TcdB-8864, TcdB-017 and TcdB-027 as said antibody TGC 16;group V consists of antibody TGC 19 (DSM ACC 2916) and/or antibodies which bind to the same binding sites on purified toxins TcdB-8864 and TcdB-027 as said antibody TGC 19;group VI consists of antibody TTC 8 (DSM ACC 2322) and/or antibodies which bind to the same binding sites on purified pan- TcdA proteins from all pathogenic C. difficile strains as said antibody TTC 8; (c) detecting an antibody reaction and constructing a reaction pattern for said at least three of the antibody groups I to VI of (b), wherein a positive symbol signifies a positive detected antibody reaction and a negative symbol signifies a negative detected antibody reaction; and (d) comparing a reaction pattern obtained in (c) with reference patterns which are obtained for said at least three of the antibody groups of (c) which are obtained from known C. difficile strains Rx1, Rx2, Rxi whose presence is being ascertained by carrying out a reaction test between at least one of their large clostridial toxins (LCT) LCT-Rx1, LCT-Rx2, LCT-Rxi and the antibodies from said at least three antibody groups I to VI of (c), wherein the reaction results obtained for each LCT and said at least three antibody groups are recorded in a pattern so that each antibody group is assigned either a positive symbol (“+”) in case of a positive detected antibody reaction or a negative symbol (“−”) in case of a negative detected antibody reaction; and (e) assessing whether a match between the reaction pattern obtained in (c) and one of the reference patterns in (d) exists, and (f) determining the presence of the C. difficile strain of the reference pattern in the sample.