Academic Journal
Oral urease rapid test serve as an effective complement to the detection of Helicobacter pylori infection through urea breath test.
| Τίτλος: | Oral urease rapid test serve as an effective complement to the detection of Helicobacter pylori infection through urea breath test. |
|---|---|
| Συγγραφείς: | He Y; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Wang C; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Luo W; Gastroenterology Department of Panyu District Central Hospital, Guangzhou, Guangdong, China., Lin W; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Li S; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Xie F; Gastroenterology Department of Panyu District Central Hospital, Guangzhou, Guangdong, China., Zhou C; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Shen J; Gastroenterology Department of Panyu District Central Hospital, Guangzhou, Guangdong, China., Zou W; Nuclear Medicine Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Zhong J; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China., Wan Y; Gastroenterology Department of Panyu District Central Hospital, Guangzhou, Guangdong, China. wanyur@163.com., Zhao J; Gastrointestinal Surgery Department of Jiangmen Central Hospital, Jiangmen, Guangdong, China. zhaojinglin@jmszxyy.com.cn.; Digestive Disease Research Center of Jiangmen Central Hospital, Jiangmen, Guangdong, China. zhaojinglin@jmszxyy.com.cn. |
| Πηγή: | BMC gastroenterology [BMC Gastroenterol] 2025 Nov 28; Vol. 25 (1), pp. 846. Date of Electronic Publication: 2025 Nov 28. |
| Τύπος έκδοσης: | Journal Article; Comparative Study |
| Γλώσσα: | English |
| Στοιχεία περιοδικού: | Publisher: BioMed Central Country of Publication: England NLM ID: 100968547 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-230X (Electronic) Linking ISSN: 1471230X NLM ISO Abbreviation: BMC Gastroenterol Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: London : BioMed Central, [2001- |
| Ιατρικοί όροι (MeSH): | Helicobacter Infections*/diagnosis , Urease*/analysis , Helicobacter pylori*/isolation & purification, Breath Tests/methods ; Urea/analysis ; Dental Plaque/microbiology ; Tongue/microbiology ; Humans ; Sensitivity and Specificity ; Female ; Double-Blind Method ; Male ; Adult ; Predictive Value of Tests ; Middle Aged ; Rapid Diagnostic Tests ; Young Adult |
| Περίληψη: | 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. |
| Competing Interests: | Declarations. Ethics approval and consent to participate: The clinical trial was performed with approval from the Ethics Committees of Jiangmen Central Hospital (No.202301 A) and Panyu District Central Hospital(No.PYZXYYEC2022-034-01). All procedures were carried out following relevant guidelines, regulations and adheres to CONSORT guidelines. The clinical trial complies with the Declaration of Helsinki, and all participants signed the informed consent form for the clinical trial. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests. |
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| Contributed Indexing: | Keywords: Helicobacter pylori infection; Rapid urease test; Urea breath test |
| Substance Nomenclature: | EC 3.5.1.5 (Urease) 8W8T17847W (Urea) |
| Entry Date(s): | Date Created: 20251129 Date Completed: 20260626 Latest Revision: 20260626 |
| Update Code: | 20260627 |
| PubMed Central ID: | PMC12661813 |
| DOI: | 10.1186/s12876-025-04446-1 |
| PMID: | 41315954 |
| Βάση Δεδομένων: | MEDLINE |
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