EVALUATION OF A RAPID, NEW METHOD FOR DETECTING SERUM IGG ANTIBODIES TO HELICOBACTER-PYLORI

There is an increased need for rapid, inexpensive tests to diagnose He licobacter pylori infection. Our objective was to determine the perfor mance characteristics of an immunochromatographic test (ICT) for detec tion of anti-H. pylori IgG antibodies. A commercially available ICT ki t. (FlexSure(R) HP) was tested with a well-characterized cohort of ban ked sera as well as with fresh serum from randomly selected symptomati c patients. The ICT was evaluated with 107 stored sera and 96 prospect ive patients. The test correctly identified 65 of 68 H. pylori-infecte d and 37 of 39 noninfected stored sera and 54 of 57 infected and 30 of 39 noninfected patients. Sensitivity, specificity, and positive and n egative predictive values were 96%, 95%, 97%, and 93% in stored serum and 95%, 77%, 86%, and 91% in fresh serum, respectively. We concluded that the ICT, reported at 4 min, is highly sensitive for detecting ant i-H. pylori IgG antibodies in human serum. With a high negative predic tive value, the test may be used to exclude H. pylori infection in sym ptomatic patients.