OBJECTIVES: To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA, JATROX and histopathologic findings. EXPERIMENTAL DESIGN: Randomized prospective study. PATIENTS: Sixty-one patients, thirty-three males and twenty-eight females, 18-73 years old, submitted to esophagogastroduodenoscopy. RESULTS: The sensitivity of HELISAL when compared to ELISA test was 60.8%, the specificity 73.3%, the positive predictive value 87.5%, the negative predictive value 37.9%, and the kappa index 0.26. When compared to histopathologic test: sensitivity 60.9%, specificity 65%, positive predictive value 78.1%, negative predictive value 44.7%, kappa 0.28. When compared to JATROX, sensitivity 57.7%, specificity 62.5%, positive predictive value 81.2%, negative predictive value 34.4%, kappa 0.21. CONCLUSION: The sensitivity of HELISAL test is lower than that of other compared tests, and the negative predictive value is very low. The specificity and the positive predictive value are higher than the sensitivity. The kappa index shows a very low concordance.
RCT Entities:
OBJECTIVES: To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA, JATROX and histopathologic findings. EXPERIMENTAL DESIGN: Randomized prospective study. PATIENTS: Sixty-one patients, thirty-three males and twenty-eight females, 18-73 years old, submitted to esophagogastroduodenoscopy. RESULTS: The sensitivity of HELISAL when compared to ELISA test was 60.8%, the specificity 73.3%, the positive predictive value 87.5%, the negative predictive value 37.9%, and the kappa index 0.26. When compared to histopathologic test: sensitivity 60.9%, specificity 65%, positive predictive value 78.1%, negative predictive value 44.7%, kappa 0.28. When compared to JATROX, sensitivity 57.7%, specificity 62.5%, positive predictive value 81.2%, negative predictive value 34.4%, kappa 0.21. CONCLUSION: The sensitivity of HELISAL test is lower than that of other compared tests, and the negative predictive value is very low. The specificity and the positive predictive value are higher than the sensitivity. The kappa index shows a very low concordance.