Serological (Immunological) Detection Methods for Helicobacter pylori (H. pylori) Used in Medical Clinics
Keywords:
Helicobacter pylori, serological diagnosis, ELISA, immunochromatographic assay, rapid test, PCR, medical clinics, H. pylori detectionAbstract
Introduction: Helicobacter pylori (H. pylori) is one of the most common causes of chronic infections worldwide, colonising the gastric mucosa of approximately 43% of the global population from 2011 to 2022. This is a gram-negative, microaerophilic bacterium that is an aetiological agent for chronic gastritis, peptic ulcer disease, gastric adenocarcinoma, and mucosa-associated lymphoid tissue (MALT) lymphoma. Due to the extensive clinical disease spectrum associated with H. pylori, it is crucial to diagnose H. pylori in a timely and accurate manner to achieve optimal management and eradication therapy.
Aim: The objective of this review is to assess critically the current serological (immunological) diagnostic testing methods, including enzyme-linked immunosorbent assay (ELISA), rapid immunochromatographic assays (lateral flow assays), and immunoblot (Western blot) techniques for the detection of H. pylori infection, as well as to evaluate the reasons preventing routine use of PCR-based diagnostic testing methods in the clinical setting; also, the overall diagnosis of each serological testing method will be assessed.
Methods: A systematic Narrative Review was conducted through searches of the following databases: PubMed, Scopus and Web of Science. Each database search was limited to studies published between 2019 and 2025 and applicable to the serological diagnostic methodologies for H. pylori detection, including; studies containing sensitivity and specificity data, clinical applicability and relation to guidelines for H. pylori diagnosis.
Results: High-Quality Testing for Active Helicobacter pylori Infection: Serological Testing (IgG) — the most commonly used method—is a very sensitive (80% to 100%) initial screening test that is used as first-line diagnostic screening in many medical clinics. Rapid point-of-care results using immunochromatographic assays typically provide good (acceptable) diagnostic accuracy. However, all serologic tests have one important limitation: they do not reliably distinguish between active [current] versus previous [resolved] infections, and therefore are not appropriate for confirming eradication of infection. PCR-based methods may have increased sensitivity and specificity, but they remain largely absent from routine clinical practice due either to prohibitive costs, to high equipment needs, or to a lack of commercially standardized assay protocols.
Conclusion: Serological tests will be the primary method of screening for Helicobacter pylori in medical clinics. Sequential algorithmic approaches using initial serologic testing for detection, followed by additional confirmatory non-invasive testing, are the optimal way to maximize diagnostic accuracy. The expanding commercial availability and reduction in cost of PCR-based assays will be a very important future direction for clinical microbiology.
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