Comparison of a monoclonal with a polyclonal antibody-based enzyme immunoassay stool test in diagnosing Helicobacter pylori infection after eradication therapy

Abstract

The new stool antigen test using monoclonal antibody is useful for the diagnosis of H. pylori eradication 4 weeks after the end of treatment.

Management ofHelicobacter pyloriinfection—the Maastricht IV/ Florence Consensus Report

“…A meta-analysis of 22 studies including 2499 patients showed that laboratory SATs using monoclonal antibodies have a high accuracy both for initial and post-treatment diagnosis of H pylori 77. These data have been confirmed by more recent studies 78 79. In contrast, the rapid in-office tests have a limited accuracy 80 81…”

Diagnosis of Helicobacter pylori Infection

“…Additional studies have evaluated different stool tests: Deguchi et al. [47] compared a monoclonal stool antigen test (Testmate pylori antigen EIA ® (Wakamoto Pharmaceutical Co. Ltd., Tokyo, Japan)) with a polyclonal enzyme immunoassay (HpSA test ® ) post‐treatment in 150 patients (28 positive) using UBT as gold standard. Sensitivities were 92 and 87%, respectively, and specificity was 98% for both tests.…”

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

“…Testmate pylori antigen (TPAg; Wakamoto Pharmaceutical Co., Ltd, Tokyo, Japan) utilizes monoclonal antibody to native H. pylori catalase [3,4] and is reported to be as accurate as UBT for the evaluation of the outcome of eradication therapy in Japanese patients [5,6]. However, the results of testing with TPAg cannot be obtained quickly because stool samples are usually transferred to central laboratories and subjected to enzyme immunoassay (EIA).…”