Evaluation of a novel rapid one-step monoclonal chromatographic immunoassay for detection of Helicobacter pylori in stool from children.

A new rapid office-based one-step monoclonal immunoassay (RAPID Hp StAR, DakoCytomation, Cambridge, UK) for detection of Helicobacter pylori antigen in stool was evaluated in children against invasive diagnostic methods and compared to the results of a monoclonal EIA targeting the same antigen (Amplified IDEIA Hp StAR, DakoCytomation, Cambridge, UK). Coded stool samples from 118 symptomatic children (0.3-18.8 years) were investigated prior to any anti-H. pylori therapy. Fifty-four children were H. pylori infected defined by positive culture and/or two other positive tests ((13)C-urea breath test, histology, rapid urea test), the remaining 64 children showed concordant negative results. Thirty-four infected children (4.8-17.8 years) were monitored with (13)C-urea breath test (five remained positive) and stool test 6-8 weeks after anti-H. pylori therapy. The immunoassays were independently read by two investigators. The monoclonal EIA showed excellent sensitivity and specificity before (98% and 100%, respectively) and after therapy (100%; 96.2%). The rapid immunoassay was invalid for technical reasons in nine samples (5.9%). The two observers agreed in 31 positive and 93 negative results, but had discordant results in 17 samples (11.2%). Overall, the rapid test showed a poor sensitivity (63.8%-71.1%), but a good specificity (91.1%-96.2%) before treatment. We conclude that the new office based monoclonal enzyme immunoassay for diagnosis of H. pylori should be modified to improve sensitivity, inter-observer-variability and some technical problems. In contrast, the monoclonal EIA stool test is highly reliable, both pre- and post therapy, and equivalent to the (13)C-urea breath test.