Diagnostic evaluation of a new IgG kit for Helicobacter pylori: comparison with commercial kits and gold standards

Helicobacter pylori (H. Pylori) infection is one of the most common chronic infectious diseases globally. Accurate diagnosis remains a challenge, as current methods have varying advantages and limitations. This study assessed the diagnostic performance of a novel domestically produced serological kit (Sina Biotech) for detecting anti- H. pylori IgG antibodies, compared with three commercial ELISA kits and two gold standard methods: the rapid urease test and histopathology. This cross-sectional study included 90 adult patients with dyspepsia who underwent upper gastrointestinal endoscopy. Based on concordant rapid urease and histopathology results, 48 patients were categorized as infected and 42 as uninfected. Anti- H. pylori IgG levels were measured using four ELISA kits: Sina Biotech, Pishtazteb, Immunolab, and Demeditec. Sensitivity and specificity were calculated for each kit. The Pishtazteb kit showed 74% sensitivity and 70% specificity. The Immunolab kit had the highest sensitivity (90%) but the lowest specificity (52%). Demeditec showed 84% sensitivity and 60% specificity. Sina Biotech demonstrated the highest specificity (86%) but lower sensitivity (68%). While Immunolab was most effective at detecting infection, Sina Biotech provided superior accuracy in identifying non-infected individuals. Characterized by high specificity, the Sina Biotech kit provides a cost-effective, locally produced serological tool for detecting Helicobacter pylori infection proving especially valuable in resource-limited settings where access to invasive diagnostics is restricted though its low sensitivity remains a clear limitation.