Chemistry: molecular biology and microbiology – Apparatus – Including measuring or testing
Patent
1995-06-01
1997-10-21
Beisner, William H.
Chemistry: molecular biology and microbiology
Apparatus
Including measuring or testing
435 12, 435 30, 4352884, 4353052, 4353053, C12M 140, C12Q 158
Patent
active
056795700
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
1. Field of Invention
The invention concerns a device for conducting combined urease tests on antrum/corpus biopsies for diagnosis of gastrointestinal disorders.
2. Brief Description of the Related Art
Gastrointestinal disorders such as duodenal or gastric ulcers, and especially chronic, active gastritis, are closely associated with the partial or diffuse colonization of Heliobacter pylori (HP) in the stomach. HP, also known as Campylobacter pylori, is a bacterium which catabolizes urea. The general indicator of bacteria such as HP which catabolize urea was described by Stuart et al. (J. Bacteriol, 1945, 49, 437) and Christensen (J. Bacterial. 1946, 52, 461). Regarding the above-mentioned illnesses, HP is regarded as an established cause of chronic Type B gastritis (Rauws et al., Gastroenterology 1988, 94, 33). In the case of an ulcer, HP represents a risk factor for predisposition of duodenal ulcer recurrence (Coghlan et al., Lancet II, 1987, 1109). In recent years, therefore, more and more reliable and, above all else, more practical indicator methods for HP have been sought. For reasons of ease of implementation and reduced cost-outlays, the analyses of biopsy probes with urease tests have acquired increased significance as opposed to very sensitive and specific culture techniques.
A culture medium for differentiation of microorganisms which catabolize urea was described by Christensen (J. Bacteriol. 1946, 52, 461) and based on the breakdown of urea by microorganisms that contain urease. The decomposition of urea into carbon dioxide and ammonia leads to an alkaline reaction in the medium, which is signalled when the color-indicator, phenol red, turns from yellow to red.
A modified quick-test which offers diagnostic advantages when the specimen exhibits only a limited colonization of Heliobacter pylori was described by Malfertheiner (Acta Therapeutica, 1988, 14, 205).
According to Borsch et al. (Immun. Infekt. 1989, 17, 83-90) the combined examination of antrum and corpus biopsies generally affords a superior diagnostic sensitivity and specificity for indication of the HP colonization of the stomach when compared with a single biopsy. Additionally, the results are thoroughly comparable to that of the more sensitive culture techniques. The combination of two antral urease tests is definitely inferior to the combined examination through biopsies of the antrum and corpus. ccording to Borsch et al, the combined urease tests of an antrum-corpus biopsy represent efficient diagnostic procedure with regard to expense and results. Urease tests are particularly the method of choice when the more sensitive, and generally more costly, culture techniques are not available.
In EP-PS 204-438 a procedure for determining the presence of urease in stomach material was described. This procedure used a combination of urea, a bactericide which sharply hindered the growth of the urease-producing organism, and a pH-indicator, (for example, phenol red) in a chemical medium, essentially bacteriological agar. The device which EP 204 438 illustrated in FIGS. 1 through 3 consists of a rectangular plate in which a small bowl fitted with a flexible covering can be used to receive the agar described above. This device is commercially available as CLO-Test.RTM..
The devices which have been previously described, and which are generally used for urease tests, essentially consist of simple, closeable containers which serve to receive either a corpus or an antrum biopsy. These containers must be correspondingly marked or tediously labeled so that the biopsies are not confused. Because these containers (for example, Eppendorf tubes) are very small, it is not possible to label them with the important patient data, with clinical documentation, and/or with test times and results.
Through use of appropriate labels, a careful marking with the important patient data is usually avoided for economic reasons. In routine laboratory operation, then, it can happen that biopsies which were taken could be falsely classified o
REFERENCES:
patent: 4654701 (1987-03-01), Yabe
patent: 4721679 (1988-01-01), Yiu et al.
WPI Abstract, AN-86-202681 of JP 61-1028941 (Jul. 1984).
Malfertheiner et al. "Campylobacter-Urase-Test (CUT) in Der Diagnostik Der Chronischen Gastritis". ACTA Therapeutica. vol. 14 (1988), pp. 205-214.
Borsch et al. "Campylobacter pylori:" Immunitat und Infektion. vol. 17, No. 3 (1989), pp. 83-90 Jun. 1989.
Heckenmuller Harald
Meyer Hansjorg
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