Introduction: The use of a rapid diagnostic technique may be extremely useful for the management of Helicobacter pylori infection. A new immunochromatographic in-office test (ImmunoCard STAT! HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio, USA) for the detection of H. pylori in feces has recently become available. The aim of the present study was to evaluate the diagnostic reliability and reproducibility of the ImmunoCard STAT! HpSA test in patients with dyspepsia.
Patients and methods: Sixty-three dyspeptic patients were enrolled. H. pylori status was determined by CLO-test and Giemsa staining of antral biopsy. Patients with a positive result for both tests were considered infected and those with a negative result for both tests were considered not infected. Fecal H. pylori antigen was tested twice by ImmunoCard STAT! HpSA. The sensitivity, specificity, positive predictive value and negative predictive value of each determination were calculated. The concordance between the two determinations was evaluated using Kappa statistics.
Results: Of the 63 patients, 46 were infected by H. pylori. Sensitivity, specificity and positive and negative predictive values were 89-91%, 86-93%, 96-98% and 72-75%, respectively. The correlation coefficient between determinations was 0.845.
Conclusion: The new ImmunoCard STAT! HpSA test shows good sensitivity and reproducibility. Therefore, it could be highly useful in the management of H. pylori infection.