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...

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Publicado en:Journal of Research in Medical Sciences Vol. 17; no. 3; pp. 212 - 217
Autores principales: Shahidi, Maneli Amin, Fattahi, Mohammad Reza, Farshad, Shohreh, Alborzi, Abdolvahab
Formato: research tables/charts Journal Article
Publicado: Wolters Kluwer India Pvt Ltd Mar2012
Acceso en línea:Ver este registro en EBSCOhost
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      pub: Wolters Kluwer India Pvt Ltd
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        atl: 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.
      aug:
        au:
          Shahidi, Maneli Amin
          Fattahi, Mohammad Reza
          Farshad, Shohreh
          Alborzi, Abdolvahab
        affil: Department of Bacteriology, Prof. Alborzi Clinical Microbiology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
      sug:
        subj:
          Stomach Diseases Microbiology
          Helicobacter Infections Diagnosis
          Diagnosis, Laboratory Methods
          Point-of-Care Testing
          Human
          Funding Source
          Biopsy
          Iran
          Data Analysis Software
          T-Tests
          Chi Square Test
          Logistic Regression
      ab: 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.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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