Objective: to determine the validity of the Cobas Core Anti-H. pylori EIA serologic test in the diagnosis of helicobacter pylori infection in an independent and blind comparison with histology of gastric antrum biopsy specimens as the gold standar. Design: Cross-sectional standard criterion study. Setting: The study was conducted at the Out Patient Department Endoscopy Unit of UP-PGH, tertiary care Hospital. Patients/Participants: Three hundred (300) consecutive patients who satisfied the following inclusion and exclusion criteria: 10 male or female age 18-80 years with indications for upper gutendoscopy; (2) with written informed consent to be included in the study (in all aspects) and to undergo upper gut endoscopy with biopsy. Exclusion Criteria: 1) intake of antibiotics, bismuth compund. H2 blockers or proton pump inhibitors within 4 weeks prior entry; 2) prevous resective gastric surgery; 3) pregnancy; 4) caustic ingestion; 5)illness or other contraindications that preclude safe endoscopy. Interventions: all included patients were subjected to two interventions: 1) upper gut endoscopy with biopsy of the gastric antrum for histologic examination: and 2) blood extraction of five (5) milliliter for the serologic test. Main Outcome Measures: Sensitivity, specificity, likelihood ratios were calculated for the serologic test and the prevalence rate of H. pylori in the study was likewise determined. Results: The sensitivity and the specificity for the serologic test were 89.25% and 80.70% respectively. Likelihood ratios, positive and negative, for the same test were 4.62 and 0.13, respectively. Prevalence rate of H.pylori was 62.0%.

Acta Medica Philippina, 2000 36 ( 1&2 ) pages 27-33