Validation of a fast immunochroniatographic test for H. pylori detection in stool

The detection of Helicobacter pylori antigens it? stool allows the noninvasive diagnosis of H. pylori gastric infection and the subsequent treatment evaluation. Recently, a new rapid immunochromatographic stool test (Immunocard STAT HpSA (TM). Meridian Bioscience), containing an immobilized anti-H. pylori monoclonal antibody, has been developed for the detection of H. pylori antigens in stool samples. The purpose of this study is to validate the test in Venezuelan patients. A total of 56 voluntary; donors with upper gastrointestinal symptoms were studied. The results of the HpSA test in feces were compared with the results of PCR in gastric biopsy DNA. Both tests showed the same results in 46 patients (21 positives and 25 negative for the presence of H. pylori). There were 6 false positives and 4 false negatives diagnosed by HpSA. The sensitivity specificity postitive predictive value and negative predictive value of Immunocard STAT HpSA test were, respectively, 84% (IC95%= 64-95), 81% (IC95%= 63-93), 78% (IC95%= 58-91) y 86% (IC95%= 68-96). The sensitivity and specificity were slightly lower than the values reported in other studies. However the Immunocard STAT HpSA test is an easy-to-use, rapid and cost-effective detection method that may be useful especially in children, as a first noninvasive diagnostic test.