Diagnostic Accuracy of Enzyme-Linked Immunosorbent Assay Compared with Polymerase Chain Reaction in Diagnosing Helicobacter pylori in Patients with Gastric Problems

Background: Helicobacter pylon, identified in 1982, is a significant gastric pathogen affecting a large portion of the global population. Objectives: This study aims to compare the diagnostic accuracy of enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) methods for detecting H. pylon, which is crucial for improving treatment strategies for gastric disorders. Methods: The study involved 70 patients at Khurshid Private Laboratory in Tehran between July and September 2022. The goal was to identify H. pylon DNA in stool samples using real-time PCR, while simultaneously testing serum samples for H. pylon using the ELISA method. Data were analyzed using SPSS software. Results: In a study of 70 patients with stomach diseases, the prevalence of H. pylon infection based on PCR results was 24.29%, with a slightly higher prevalence in females than males. For diagnosing H. pylon infection, the optimal IgA cut-off point was identified as 7.15 mg/dL, yielding a sensitivity of 88%, specificity of 89%, and an AUC of 0.94. The optimal cut-off for IgG was 95.70 mg/dL, with a sensitivity of 76%, specificity of 94%, and an AUC of 0.88, using PCR results as the gold standard. Conclusions: This study emphasizes the importance of accurately diagnosing H. pylon infections, highlighting that PCR offers greater sensitivity and specificity than ELISA. By establishing optimal IgA and IgG cut-off points, the study enhances diagnostic precision, which could lead to improved therapeutic interventions and patient outcomes.