Evaluation of a latex agglutination test (PYLOGEN) for the detection of Helicobacter pylori in stool specimens.

The aim of the study was to assess a new latex agglutination (LA) stool antigen assay (PYLOGEN; CerTest Biotec, Zaragoza, Spain) in the diagnosis of Helicobacter pylori infection and to monitor its eradication after treatment. The LA test has been approved for sale in Europe, and its approval from the US Food and Drug Administration is still pending. The individuals enrolled were classified into 3 groups of patients: Group 1 consisted of 38 patients who are H. pylori positive. The diagnosis of H. pylori infection was established if there was concordance between 2 test results (urea breath test [UBT], rapid urease test, and histopathologic study) or if the culture alone was positive. Patients with only 1 positive test were considered indeterminate and were excluded from the study. Group 2 comprised 9 patients without positive tests and who were considered to be H. pylori negative. Group 3 consisted of 57 patients who received eradication treatment. The sensitivity and specificity of the test were 78.9% and 100%, respectively. The results of the UBT of the patients were studied 6 weeks after eradication therapy. The sensitivity and specificity of the LA test relative to UBT for patients after treatment were 75% and 93.3%, respectively.