Applicability of a rapid stool antigen test, using monoclonal antibody to catalase, for the management of Helicobacter pylori infection

Abstract

Most monoclonal antibody-based stool antigen tests are of the "send-out" format. Rapid Testmate pylori antigen (Rapid TPAg) uses monoclonal antibody and is an "in-the-office" test. The aim of this study was to examine the usefulness of Rapid TPAg for the management of H. pylori infection. One-hundred and two consecutive patients who received H. pylori eradication therapy underwent both urea breath test (UBT) and Rapid TPAg at 5-6 weeks after finishing the eradication therapy. Stool samples were maintained at -20, 5, 25, and 40°C and subjected to Rapid TPAg after 1-7 days. Stool samples were also tested by enzyme immunoassay (EIA) to quantify antigenicity. The agreement between Rapid TPAg and UBT in the evaluation of the results of H. pylori eradication treatment was 94.1%. The overall accuracy of Rapid TPAg and UBT to determine H. pylori eradication was 98.0 and 96.0%, respectively. The results of Rapid TPAg were not altered after storage of samples at -20 to 40°C for 7 days. Antigenicity quantified by EIA did not decrease significantly after 7 days. Rapid TPAg is a useful diagnostic test for immediate and accurate determination of the results of H. pylori eradication therapy. The antigenicity of stool sample suspensions was preserved for 7 days in the collection devices.