Validity of rapid urease test using swab of gastric mucus to mucosal forceps and 13 C-urease breath test: a multicenter prospective observational study

• Published in: BMC gastroenterology Vol. 24; no. 1; pp. 258 - 6
• Main Authors: Yoshikawa, Takaaki, Yamauchi, Atsushi, Kou, Tadayuki, Murao, Takahisa, Kamada, Tomoari, Suehiro, Mitsuhiko, Kawano, Koichiro, Haruma, Ken, Yazumi, Shujiro
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 09.08.2024; BioMed Central; BMC
• Subjects: 13 C-urea breath test; Accuracy; Adult; Aged; Aged, 80 and over; Atrophic gastritis; Biopsy; Breath Tests - instrumentation; Breath Tests - methods; Cancer therapies; Carbon Isotopes; Diagnosis; Endoscopy, Digestive System; Enzymes; Female; Gastric Mucosa - microbiology; Health aspects; Helicobacter infections; Helicobacter Infections - diagnosis; Helicobacter Infections - microbiology; Helicobacter pylori; Helicobacter pylori - enzymology; Helicobacter pylori - isolation & purification; Hospitals; Humans; Hydrolases; Infections; Informed consent; Kappa coefficient; Male; Measurement; Middle Aged; Mucosa; Pharmaceuticals; Prospective Studies; Rapid urease test; Regression analysis; Reproducibility of Results; Sensitivity and Specificity; Sodium; Surgical Instruments - microbiology; Urease; Urease - analysis; Urease - metabolism; Japan; Rapid urease test; Helicobacter pylori; Atrophic gastritis; 13 C-urea breath test
• ISSN: 1471-230X; 1471-230X
• DOI: 10.1186/s12876-024-03344-2

Theoretically, a rapid urease test (RUT) using a swab of the gastric wall (Swab-RUT) for Helicobacter pylori (H. pylori) is safe. However, the validity and utility of Swab-RUT remain unclear. Therefore, we assessed the validity and utility of Swab-RUT compared to RUT using mucosal forceps of the gastric wall (Forceps-RUT) and C-urea breath test (UBT). This study was a multicenter prospective observational study. When the examinees were suspected of H. pylori infection during esophagogastroduodenoscopy, we performed Swab-RUT and Forceps-RUT continuously. When the examinees were not suspected of H. pylori infection, we performed Swab-RUT alone. We validated the status of H. pylori infection using UBT. Ninety-four examinees were enrolled from four institutions between May 2016 and December 2020 (median age [range], 56.5 [26-88] years). In this study, the sensitivity, specificity, and accuracy of Swab-RUT to UBT were 0.933 (95% confidence interval: 0.779-0.992), 0.922 (0.827-0.974), and 0.926 (0.853-0.970), respectively. The Kappa coefficient of Swab-RUT to UBT was 0.833, and that of Swab-RUT to forceps-RUT was 0.936. No complications were observed in this study. Swab-RUT is a valid examination for the status of H. pylori infection compared to the conventional Forceps-RUT.