Testing for Helicobacter pylori infection: validation and diagnostic yield of a near patient test in primary care

摘要: Abstract Objective: To evaluate the performance of a near patient test for Helicobacter pylori infection in primary care. Design: Validation study performed within randomised trial four management strategies dyspepsia. Setting: 43 general practices around Nottingham. Subjects: 394 patients aged 18-70 years presenting with recent onset Main outcome measures: Results Flex Sure compared an enzyme linked immunosorbent assay (ELISA; HM-CAP) identical antigen profile and results earlier validation secondary care Diagnostic yield undergoing endoscopy on basis their result those referred directly endoscopy. Results: When used had sensitivity specificity 67% (95% confidence interval 59% to 75%) 98% 99%) 92% (87% 97%) 90% (83% when previously Of H refer group 14% (28/199) were found have conditions which eradication was appropriate 23% (39/170) Conclusions: significantly poorer than About third who would benefited from not detected. Near tests need be validated before they are incorporated into policies Key messages been recommended dyspepsia without proper evaluation Such should high avoid missing treatable illness related The lower reported studies Fewer expected numbers pathology identified