Oral urease rapid test serve as an effective complement to the detection of Helicobacter pylori infection through urea breath test.

The urea breath test (UBT) is the clinic’s most popular and accurate non-invasive diagnostic method for Helicobacter pylori (HP) infection. Yet, it is time-consuming and unavailable to some individuals. The oral rapid urease test (RUT) is an emerging non-invasive convenience method but lacks clinical data support. A double-center, double-blind, methodological comparative design experiment is invited to evaluate the consistency of the oral RUT with UBT. 247 participants were enrolled. Their Dental plaque and tongue coating samples were collected, blind and tested with RUT. The significant association between the RUT and UBT was analyzed. The oral RUT showed a high level of agreement with the UBT. The sensitivity of the test reagent was 98.63% (95% CI: 92.64%, 99.76%), and the specificity was 96.34% (95% CI: 92.25%, 98.31%). The overall conformity rate was 97.05% (95% CI: 94.03%, 98.56%). The positive predictive value was 92.31%, and the negative predictive value was 99.37%. The positive likelihood ratio was 26.96, and the negative likelihood ratio was 0.01. The Kappa value was 0.97. The efficacy of oral RUT for HP infection diagnosis is extremely consistent with the UBT.Trial registrationClinical trial of rapid test paper (chemical reaction method) for Helicobacter pylori (NO.ChiCTR2500097395), Registration Date2025.02.19.Retrospectively registered.