Development of serological assays to identify Helicobacter suis and Helicobacter pylori infections

Helicobacter suis hosted by hogs is the most prevalent gastric non- Helicobacter pylori Helicobacter species found in humans. Recent studies suggest that the H. suis infection has already induced many cases of gastric disease. However, the infection period and route of H. suis from hogs remain unclear. Because diagnostic methods based on the urease activity of H. suis often yield negative judgments, there is no reliable method for diagnosing H. suis infection in clinical practice without gastric biopsy specimens. We developed the world’s first ELISA to simultaneously diagnose H. suis and H. pylori infection in a single test. The area under the ROC curve was 0.9648 or 0.9200 for identifying H. suis or H. pylori infection, respectively. The sensitivity, specificity, and positive and negative predictive values for identifying H. suis infection were 100%, 92.6%, 76.9%, and 100%, and those for identifying H. pylori infection were 88.2%, 87.5%, 65.2%, and 96.6%, respectively. (150 words) ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by MEXT/JSPS KAKENHI (JP19H03474, JP20K08365) and AMED (JP20fk0108148, JP20fk0108133). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Research Ethics Committees (REC) of the National Institute of Infectious Diseases (NIID) and Kitasato University approved this study under registration numbers 1284 and 18100, respectively. The ethical review was also approved at the following eight medical institutions: Junpukai Health Maintenance Center, Kyorin University Hospital, Tokai University Hospital, Toyama University Hospital, Takeda Hospital, Aichi Medical University Hospital, Kakogawa Central Municipal Hospital, and Kanazawa Municipal Hospital. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data produced in the present work are contained in the manuscript.