Maryam Esmaeili - Department of Medical Biotechnology, Biotechnology Research Center, Pasteur Institute of Iran, Tehran
Samaneh Saberi - Department of Medical Biotechnology, Biotechnology Research Center, Pasteur Institute of Iran, Tehran
Mehdi Alikhani - Department of Medical Biotechnology, Biotechnology Research Center, Pasteur Institute of Iran, Tehran
Mojgan Hatefi - Department of Medical Biotechnology, Biotechnology Research Center, Pasteur Institute of Iran, Tehran
Mohammad Tashakoripour - ۲Department of Gastroenterology, Amiralam Hospital, Tehran University of Medical Sciences, Tehran
Mahmoud Eshagh Hosseini - ۲Department of Gastroenterology, Amiralam Hospital, Tehran University of Medical Sciences, Tehran
Mohammad Ali Mohagheghi - Cancer Research Center, Tehran University of Medical Sciences, Tehran
Marjan Mohammadi - Department of Medical Biotechnology, Biotechnology Research Center, Pasteur Institute of Iran, Tehran

Introduction: Helicobacter pylori, as an etiologic cause of peptic ulcers and gastric cancer, should be tested and treated. The true state of infection can only be detected by isolation of gastric biopsies through the invasive method of gastroscopy. However, there are several non-invasive methods for detection of infection, the most common of which is serology. Methods: Here we have evaluated the efficacy of two commonly used commercial IgG-based ELISA kits (Kit-۱ and Kit-۲) against the endoscopy (biopsy)-based methods of rapid urease test (RUT) and bacterial culture. Our study population included ۷۵۴ subjects categorized as having: ۱) nonulcer dyspepsia (NUD, N=۴۸۵), ۲) peptic ulcer disease (PUD, N=۶۵), and ۳) gastric cancer (GC, N=۲۰۴). Results: The rates of agreement between the results obtained by Kit-۱, Kit-۲ and both kits with culture/RUT were ۶۲.۴% (۳۱۸ of ۵۰۰, P=۰.۰۰۰۱), ۷۴.۴% (۱۸۳ of ۲۴۶, P<۰.۰۰۰۱), and ۸۱.۸% (۱۱۷ of ۱۴۳, P<۰.۰۰۰۱), respectively. The agreement rate between the two kits, regardless of the results of the culture and RUT, was ۸۳.۶% (۱۴۷ of ۱۷۶, P<۰.۰۰۰۱), leaving ۱۶.۴% of the subjects with discrepant results. The sensitivity rate and more drastically the specificity rates (against biopsy-based tests), claimed by Kit-۱ (۱۰۰% and ۷۵%) and Kit-۲ (>۹۶% and >۹۹%) were significantly reduced (Kit-۱: ۹۴.۴% and ۴۰.۳%; Kit-۲: ۸۶.۵% and ۷۱%) for the Iranian population. Conclusion: Our data raises questions regarding the accuracy of commercial IgG-based ELISA kits for the detection of H. pylori infection. Therefore, caution should be practiced when such tests are used as the sole basis of medical decision making.

Serology, ELISA, Sensitivity, Specificity, Gold Standard