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Evaluation of the Performance Characteristics of H. pylori Antibody Rapid Test for Point-of-Care Diagnosis

Zhang Lei, Yang Feng, Zhu Junzhe

Helicobacter pylori, a spiral-shaped bacterium, predominantly inhabits the human gastric mucosa. Recognized as a primary causative agent in gastritis, gastric ulcers, and gastric cancer, H. pylori comprises the gastric mucosa’s protective layer via its enzymatic and toxic activities, precipitating inflammation and tissue damage. Given these implications, early and accurate diagnosis, followed by intervention, is paramount to curb the spread of this infection. This study evaluates the H. pylori Antibody Rapid Test's diagnostic precision in identifying Helicobacter pylori infection is evaluated

This rapid immunoassay utilizes chromatography to qualitatively detect H. pylori in human whole blood, serum, or plasma. Its effectiveness is assessed in comparison to established standards such as biopsy, histology, and the Rapid Urease Test (RUT), with results demonstrating its excellent diagnostic capabilities. The test validated a sensitivity of 96.8% and a specificity of 93.0% when compared to results obtained from Biopsy/Histology/RUT. As a reliable diagnostic tool, the H. pylori Antibody Rapid Test facilitates the swift detection of H. pylori infection, expediting the commencement of treatment, reducing the transmission of Helicobacter pylori, and guiding treatment decisions. These performance evaluations underscore its potential to refine clinical approaches, improve patient health outcomes, and enhance their quality of life. In the realm of H. pylori infection diagnosis, the H. pylori Antibody Rapid Test stands as a valuable tool, offering convenience, efficiency, and dependable results. Its integration into clinical practice can significantly contribute to early detection and management of H. pylori infection, ultimately leading to enhanced patient outcomes and a reduction in the burden of H. pylori-related gastric diseases.