ABSTRACT
Objective:To evaluate the effects of the cassette 14C-urea breath test kit, scintillation sampling bottle (solid-state scintillation method) and liquid scintillation 14C-urea breath test kit in the diagnosis of Helicobacter pylori ( H. pylori) infection. Methods:From January 7 to October 28, 2020, 239 patients were enrolled who visited Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine, the Second Affiliated Hospital of Zhejiang University School of Medicine and the First Affiliated Hospital of Nanchang University. All subjects first received 14C-urea breath test.Within >1 to <7 days after gas collection, mucosal tissues were taken under gastroscopy for gold standard test, including biopsy and rapid urease test (RUT). If both biopsy and RUT indicated H. pylori positive, the result of gold standard test was H. pylori positive, and if both were negative, the result of gold standard test was H. pylori negative. If the results of biopsy and RUT were inconsistent, they were not included in the subsequent analysis. Based on the results of gold standard test, the sensitivity, specificity, accuracy, positive predictive value and negative predictive value of the cassette 14C-urea breath test kit, scintillation sampling bottle, and liquid scintillation 14C-urea breath test kit in the diagnosis of H. pylori infection were analyzed. The safety of the test was evaluated by whether there were any adverse events during the test. Descriptive methods were used for statistical analysis. Results:Among the 239 subjects, 12 cases did not complete the test, 227 subjects finally completed the test. The test completion rate was 95.0% (227/239). No.008 patient was only included in the analysis of cassette 14C-urea breath test kit and scintillation sampling bottle because of lacking the result of liquid scintillation breath test. The results of gold standard test showed that among 227 patients, 87 cases were H. pylori positive, 118 cases were H. pylori negative. The results of biopsy and RUT were inconsistent in 22 cases, so they were not included in the subsequent analysis. Excluding No.008 patient, the results of gold standard test showed that 86 cases were H. pylori positive and 118 cases were negative. Based on the results of gold standard test, the sensitivity, specificity, accuracy, positive predictive value, and negative predictive value of cassette 14C-urea breath test kit, scintillation sampling bottle, and the liquid scintillation 14C-urea breath test kit in the diagnosis of H. pylori infection were 91.9%, 100.0%, 96.6%, 100.0% and 94.4%, respectively; 95.4%, 97.5%, 96.6%, 96.5% and 96.6%, respectively; and 96.5%, 99.2%, 98.0%, 98.8% and 97.5%, respectively. Only one adverse event (right upper abdominal pain after eating) occurred. Combined with the patients condition, the adverse event was determined as the onset of chronic cholecystitis and it might not be related to the test medication. Conclusions:Cassette 14C-urea breath test kit, scintillation sampling bottle, and liquid scintillation 14C-urea breath test kit have reliable performance, good safety, and high sensitivity, specificity and accuracy in the diagnosis of H. pylori infection, which are worthy of clinical application.