Author(s)

Zhang Lei ¹, Yang Feng ², Zhu Junzhe ³

Affiliation(s)

¹ Zhejiang Gongshang University, Hangzhou, Zhejiang, 310018, China
² Community Health Service Center, Yipeng Street, Qiantang District, Hangzhou, Zhejiang, 310000, China
³ Wenzhou Medical University, Wenzhou, Zhejiang, 310000, China

Corresponding Author

Zhang Lei

ABSTRACT

Helicobacter pylori (H. pylori) is a bacterial pathogen known to colonize the human stomach and is associated with various gastrointestinal disorders. H. pylori antigen rapid testing is a qualitative method that utilizes rapid chromatographic immunoassay to detect the presence of H. pylori antigen in human fecal specimens. This study aimed to assess the performance of The H. pylori Antigen Rapid Test Cassette (Feces), developed by Hangzhou AllTest Biotech Co., Ltd., by evaluating its sensitivity, specificity, and accuracy. A total of 362 fecal specimens obtained from symptomatic and asymptomatic individuals were included in the analysis. The H. pylori antigen rapid test cassette was compared to endoscopy-based methods, which served as the reference standard. Among the specimens, 170 were confirmed negative, while 192 were confirmed positive by endoscopy-based methods. The study findings demonstrated a high relative sensitivity of 98.8% for the H. pylori antigen rapid test cassette, indicating its ability to accurately identify 98.8% of true positive cases. Additionally, the test exhibited a relative specificity of 98.4%, accurately identifying 98.4% of negative cases. Overall, the test displayed an accuracy of 98.6%, reflecting a high proportion of correct results. These results suggest that the AllTest H. pylori Antigen Rapid Test Cassette is an effective method for early diagnosis of H. pylori infection, providing reliable results for clinical decision-making. Moreover, this method is user-friendly, with results obtainable within 10 minutes, non-invasive, and non-traumatic. This makes it valuable, particularly in areas with limited healthcare resources. It can expedite screening, facilitate prompt diagnosis, and enable timely treatment, thereby improving patient outcomes and contributing to global public health goals.

KEYWORDS

Helicobacter pylori; H. pylori; sensitivity; specificity; accuracy; diagnosis; rapid test; antigen; feces

CITE THIS PAPER

Zhang Lei, Yang Feng, Zhu Junzhe, Evaluation of the Fecal Antigen Rapid Test for Early Detection of Helicobacter Pylori Infection. MEDS Clinical Medicine (2024) Vol. 5: 54-59. DOI: http://dx.doi.org/10.23977/medsc.2024.050208.

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