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Diagnosis
The near-patient test FlexSure had low sensitivity and high specificity for detecting Helicobacter pylori infection

https://doi.org/10.1136/ebm.5.4.127

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    (1999) BMJ 319, 1236; Duggan AE, Elliott C, Logan RF. . . Testing for Helicobacter pylori infection: validation and diagnostic yield of a near patient test in primary care.. Nov 6:. :. –9..
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 QUESTION: In adults who have symptoms of dyspepsia and consult a general practitioner, is a near patient test (FlexSure) accurate for detecting Helicobacter pylori infection?

    Design

    Blinded comparison of a near patient test with an enzyme linked immunosorbent assay (ELISA) within a randomised controlled trial of 4 management strategies for dyspepsia.

    Setting

    43 general practices in Nottinghamshire, England.

    Participants

    762 adults who were 18–73 years of age (mean age 42 y) and had symptoms of dyspepsia of sufficient severity to justify empiric treatment with H2-antagonists or proton pump inhibitors. Exclusion criteria were symptoms consistent with malignant tumors, a history of peptic ulcer or reflux esophagitis, investigation for dyspepsia in the previous 5 years, treatment in the previous 6 months with non-steroidal anti-inflammatory drugs or H pylori eradication treatment, or ≥3 prescriptions in the previous 6 months for acid …

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    Footnotes

    • Sources of funding: NHS Primary/Secondary Interface R&D Programme; Trent Region R&D; Wyeth-Lederle; Abbott Laboratories. Near patient tests and ELISAs were provided by SmithKline Diagnostics.

    • For correspondence: Dr R F Logan, Divisions of Public Health and Epidemiology and Gastroenterology, University of Nottingham, Nottingham NG7 2UH, UK. Fax +44 (0)115 970 9316.