Evaluation of a new Near Patient Test for the detection of Helicobacter pylori.

Objective: Peptic ulcer disease is rare in the absence of Helicobacter pylori. Testing for H. pylori has recently become easier with the development of Near Patient Tests. However, the validity of many of these tests is unknown. The aim of this study was to assess the validity of the QuickVue one-st...

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Published in:European Journal of Gastroenterology & Hepatology Vol. 10; no. 2; pp. 133 - 137
Main Authors: Duggan, Anne E., Hardy, Elaine, Hawkey, Christopher J., Duggan, A E, Hardy, E, Hawkey, C J
Format: clinical trial research Journal Article
Published: Lippincott Williams & Wilkins Feb1998
Online Access:View this record in EBSCOhost
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      dt: Feb1998
      vid: 10
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      pid: 5086
      pub: Lippincott Williams & Wilkins
      place: Baltimore, Maryland
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        10.1097/00042737-199802000-00006
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        atl: Evaluation of a new Near Patient Test for the detection of Helicobacter pylori.
      aug:
        au:
          Duggan, Anne E.
          Hardy, Elaine
          Hawkey, Christopher J.
          Duggan, A E
          Hardy, E
          Hawkey, C J
        affil: Division of Gastroenterology. University Hospital, Nottingham NG7 ZUH, UK
      sug:
        subj:
          Immunoenzyme Techniques
          Serologic Tests Methods
          Helicobacter Infections Diagnosis
          Helicobacter Pylori
          Retrospective Design
          Female
          Aged, 80 and Over
          False Positive Results
          Predictive Value of Tests
          False Negative Results
          Middle Age
          Male
          Adult
          Sensitivity and Specificity
          Human
          Aged
          Clinical Trials
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Aged, 80 & over
          Middle Aged: 45-64 years
          Adult: 19-44 years
          Aged: 65+ years
          Female
          Male
      ab: Objective: Peptic ulcer disease is rare in the absence of Helicobacter pylori. Testing for H. pylori has recently become easier with the development of Near Patient Tests. However, the validity of many of these tests is unknown. The aim of this study was to assess the validity of the QuickVue one-step Near Patient Test for H. pylori in a group of patients attending for endoscopy at a tertiary referral hospital.Methods: In a retrospective study the QuickVue one-step serum test (Quidel) was performed on the stored serum from 193 patients whose H. pylori status had been determined by a 'gold standard' using urease testing, histology, culture and 14C-urea breath testing. Twenty four other patients presenting to endoscopy were studied prospectively. For these patients QuickVue was performed on capillary and venous samples and the results were compared to a similar 'gold standard'. Enzyme immunoassay (Premier, H. pylori, Meridian Diagnostics, OH, USA) was used to define H. pylori status of patients with indeterminate H. pylori status by the above criteria.Results: In the retrospective study the QuickVue one-step H. pylori test had a sensitivity (CI) of 82% (75-89) and specificity of 83% (74-92). In the prospective study on capillary blood its sensitivity (CI) was 89% (52-100) and its specificity 93% (68-100); and on venous blood, 78% (40-97) and 93% (68-100). Premier has previously been shown to have a sensitivity and specificity of 100%.Conclusion: In this group of patients the QuickVue one-step H. pylori Near Patient Test was less accurate than the Premier ELISA test, but its ease of use and availability in primary care make it useful for patient screening.
      pubtype: Academic Journal
      doctype:
        clinical trial
        research
        Journal Article
      ougenre: Article
    language: English
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