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Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders
BACKGROUND: H. pylori is a urease positive organism, and this activity in a gastric biopsy could be considered as a proof of the presence of H. pylori. For the reasons of high price and difficult accessibility to the commercial CLO-test in Iran, we designed an affordable equivalent test with high sp...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Medknow Publications & Media Pvt Ltd
2012
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527036/ https://www.ncbi.nlm.nih.gov/pubmed/23267370 |
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author | Shahidi, Maneli Amin Fattahi, Mohammad Reza Farshad, Shohreh Alborzi, Abdolvahab |
author_facet | Shahidi, Maneli Amin Fattahi, Mohammad Reza Farshad, Shohreh Alborzi, Abdolvahab |
author_sort | Shahidi, Maneli Amin |
collection | PubMed |
description | BACKGROUND: H. pylori is a urease positive organism, and this activity in a gastric biopsy could be considered as a proof of the presence of H. pylori. For the reasons of high price and difficult accessibility to the commercial CLO-test in Iran, we designed an affordable equivalent test with high specificity, accuracy and availability. METHODS: Biopsy samples from 80 symptomatic patients with gastrointestinal problems were included in this study. The results of our in-house made rapid urease kit were compared with the commercial CLO-test up to 3 hours and 24 hours after inoculation of the biopsy samples. Culture results and gram staining were proposed as gold standard. RESULTS: Helicobacter pylori was isolated from 36 patients (45.0%) after cultivation of biopsy samples. After 3 hours, 33 (91.6%) cases of positive samples for H. pylori, showed urease positive reaction using both, in-house made and CLO-test kits. However, 2 (5.5%) cases showed urease reaction at 24 hours using both the kits. The specificity of 100% was determined for both, in-house made and commercial CLO-test kits after 3 hours. The sensitivity for both the kits was estimated at 97.1% after 3hours. However, after 24 hours, sensitivity and specificity of 97.1% and 88.64% was estimated for the in-house and 97.2 % and 95.4% for the commercial CLO-test kits, respectively. CONCLUSION: Specificity and sensitivity of 100% and 97.1 % for up to 3 hours follow biopsy sampling, could be considered as an advantage for our in-house rapid urease kit. Moreover, the rapid urease agar media designed in our lab is cost-effective with adequate sensitivity and specificity levels for the detection of H. pylori, compared with the commercial CLO-test. |
format | Online Article Text |
id | pubmed-3527036 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2012 |
publisher | Medknow Publications & Media Pvt Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-35270362012-12-24 Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders Shahidi, Maneli Amin Fattahi, Mohammad Reza Farshad, Shohreh Alborzi, Abdolvahab J Res Med Sci Original Article BACKGROUND: H. pylori is a urease positive organism, and this activity in a gastric biopsy could be considered as a proof of the presence of H. pylori. For the reasons of high price and difficult accessibility to the commercial CLO-test in Iran, we designed an affordable equivalent test with high specificity, accuracy and availability. METHODS: Biopsy samples from 80 symptomatic patients with gastrointestinal problems were included in this study. The results of our in-house made rapid urease kit were compared with the commercial CLO-test up to 3 hours and 24 hours after inoculation of the biopsy samples. Culture results and gram staining were proposed as gold standard. RESULTS: Helicobacter pylori was isolated from 36 patients (45.0%) after cultivation of biopsy samples. After 3 hours, 33 (91.6%) cases of positive samples for H. pylori, showed urease positive reaction using both, in-house made and CLO-test kits. However, 2 (5.5%) cases showed urease reaction at 24 hours using both the kits. The specificity of 100% was determined for both, in-house made and commercial CLO-test kits after 3 hours. The sensitivity for both the kits was estimated at 97.1% after 3hours. However, after 24 hours, sensitivity and specificity of 97.1% and 88.64% was estimated for the in-house and 97.2 % and 95.4% for the commercial CLO-test kits, respectively. CONCLUSION: Specificity and sensitivity of 100% and 97.1 % for up to 3 hours follow biopsy sampling, could be considered as an advantage for our in-house rapid urease kit. Moreover, the rapid urease agar media designed in our lab is cost-effective with adequate sensitivity and specificity levels for the detection of H. pylori, compared with the commercial CLO-test. Medknow Publications & Media Pvt Ltd 2012-03 /pmc/articles/PMC3527036/ /pubmed/23267370 Text en Copyright: © Journal of Research in Medical Sciences http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Shahidi, Maneli Amin Fattahi, Mohammad Reza Farshad, Shohreh Alborzi, Abdolvahab Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title | Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title_full | Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title_fullStr | Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title_full_unstemmed | Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title_short | Validation of an in-house made rapid urease test kit against the commercial CLO-test in detecting Helicobacter pylori infection in the patients with gastric disorders |
title_sort | validation of an in-house made rapid urease test kit against the commercial clo-test in detecting helicobacter pylori infection in the patients with gastric disorders |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527036/ https://www.ncbi.nlm.nih.gov/pubmed/23267370 |
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