Validation of a Rapid Stool Antigen Test for the Diagnosis of Helicobacter pylori Infection in Dyspeptic Patients-A Study from Central Kerala DC10-DC13
Dr. Suryakala Ravi Nair,
Saaya, Vattekkattu House, Ollukkara. P.O. Kalathode, Thrissur-680655, Kerala, India.
Introduction: Accurate diagnosis of Helicobacter pylori infection in dyspeptic patients is highly essential to institute eradication therapy and to prevent complications. The introduction of â€˜test and treat strategyâ€™ using validated rapid stool antigen tests can significantly reduce the burden of H.pylori infection in developing countries.
Aim: To validate a rapid monoclonal immunochromatographic stool antigen test, EpituubÂ® fecal H.pylori antigen test kit for the diagnosis of Helicobacter pylori infection among dyspeptic patients.
Materials and Methods: Stool samples were collected for EpituubÂ® fecal H.pylori antigen test from randomly selected patients undergoing upper gastrointestinal endoscopy for the evaluation of dyspepsia. Gastric biopsy samples were also collected for urease test and histopathology. The diagnostic criteria for H.pylori infection was defined as a positive test result for both rapid urease test and histopathology examination. All other combination of the results was considered as negative. The test performance was assessed by determining sensitivity, specificity, positive predictive value and negative predictive value with reference to histopathology examination and rapid urease test.
Results: Based on the reference criteria, 31% (35/113) patients were diagnosed as H.pylori infected and 41% (46/113) were rapid stool antigen test positive. The sensitivity, specificity, positive predictive value and negative predictive value of the EpituubÂ® fecal H.pylori antigen test kit were 88.5%, 80.76%, 67.3% and 94.02% respectively.
Conclusion: EpituubÂ® fecal H.pylori antigen test can be used as a valid alternative to invasive tests for the diagnosis of H.pylori infection. It is also relatively cheap, fast and easy to perform.