Abstract
Helicobacter pylori infection poses significant health risks, such as gastric adenocarcinoma, necessitating accurate diagnosis and effective treatment in primary care. This study evaluated the diagnostic efficacy of the serological current infection marker (CIM) test in identifying current H. pylori infection. The CIM test samples from 159 participants undergoing gastroscopy were collected, and H. pylori-positive outpatients received triple therapy based on histology or rapid urease test results. Following treatment, 45 patients underwent a (13)C-urea breath test and the CIM test for eradication assessment. For pre-eradication, the CIM test demonstrated 89.6% sensitivity, 95.7% specificity, 93.8% positive predictive value, 92.6% negative predictive value, and 93.1% accuracy. Following post-eradication, the CIM test exhibited sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 71.4%, 92.1%, 62.5%, 94.6%, and 88.9%, respectively, using the (13)C-urea breath test as the reference standard. The CIM test showcased commendable diagnostic performance, emphasizing its efficacy in both pre- and post-eradication scenarios. Notably, the accuracy, non-invasiveness, user-friendliness, and cost-effectiveness of the CIM test advocate for its recommendation as a preferred diagnostic tool in primary care settings for H. pylori infection detection.