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

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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.