{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,29]],"date-time":"2026-10-29T05:31:49Z","timestamp":1793251909114,"version":"4.5.0"},"reference-count":15,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T00:00:00Z","timestamp":1788825600000},"content-version":"vor","delay-in-days":7,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,1]],"date-time":"2026-09-01T00:00:00Z","timestamp":1788220800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Helicobacter"],"published-print":{"date-parts":[[2026,9]]},"abstract":"ABSTRACT<\/jats:title>\n \n Background<\/jats:title>\n \n \n Helicobacter pylori<\/jats:italic>\n <\/jats:styled-content>\n (\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n ) infection is a major risk factor for gastric cancer (GC) and other gastrointestinal diseases. Current non\u2010invasive detection methods for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n , such as\n 13<\/jats:sup>\n C\u2010urea breath test (UBT), are constrained by high cost, radiation concerns, prolonged test duration, and susceptibility to false negative results due to medication use. Thus, a rapid, cost\u2010effective, accurate, and medication\u2010resistant detection method for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n infection is urgently needed.\n <\/jats:p>\n <\/jats:sec>\n \n Materials and Methods<\/jats:title>\n \n This study developed a novel point\u2010of\u2010care testing for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n infection based on 16S rRNA isothermal amplification, using throat swabs as the detection samples (POCT). To systematically evaluate its diagnostic performance, a multi\u2010center cross\u2010sectional paired diagnostic study was conducted at Shandong Public Health Clinical Center and East Campus of Qilu Hospital, Shandong University from January 2025 to August 2025. This study enrolled a total of 543 participants, all of whom underwent both POCT and UBT simultaneously on the same day. Regarding UBT as the reference gold standard, the diagnosis metrics including accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of POCT for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n detection were analyzed to evaluate its clinical application.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n The POCT assay exhibited an overall accuracy of 95%, sensitivity of 89%, and specificity of 97%. PPV and NPV were 90% and 96%, respectively. Its high agreement with UBT was confirmed by a Kappa value of 0.860 (\n p<\/jats:italic>\n \u2009<\u20090.01). Additionally, the diagnostic performance of POCT also demonstrated high consistency between two centers.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n \n The 16S rRNA isothermal amplification point\u2010of\u2010care testing exhibits excellent diagnostic accuracy for\n \n H. pylori<\/jats:italic>\n <\/jats:styled-content>\n infection. It holds the potential to serve as an economic, efficient, and widely applicable alternative to the traditional UBT.\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/hel.70164","type":"journal-article","created":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T10:23:22Z","timestamp":1788863002000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A Novel\n Helicobacter pylori<\/i>\n Test Based on 16S rRNA Isothermal Amplification Point\u2010of\u2010Care Testing of Throat Swab"],"prefix":"10.1111","volume":"31","author":[{"ORCID":"https:\/\/orcid.org\/0009-0001-2979-5279","authenticated-orcid":false,"given":"Ziyu","family":"Liu","sequence":"first","affiliation":[{"name":"Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"},{"name":"Zhongshan School of Medicine Sun Yat\u2010Sen University Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-4614-8084","authenticated-orcid":false,"given":"Minqing","family":"Wu","sequence":"additional","affiliation":[{"name":"Cancer Prevention Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanhong","family":"Li","sequence":"additional","affiliation":[{"name":"Cancer Prevention Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qiyu","family":"Huang","sequence":"additional","affiliation":[{"name":"Cancer Prevention Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiying","family":"Mao","sequence":"additional","affiliation":[{"name":"Department of Radiology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0633-1906","authenticated-orcid":false,"given":"Yong","family":"Diao","sequence":"additional","affiliation":[{"name":"School of Medicine Huaqiao University Quanzhou Fujian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Huiyong","family":"Yang","sequence":"additional","affiliation":[{"name":"School of Medicine Huaqiao University Quanzhou Fujian China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuying","family":"Liu","sequence":"additional","affiliation":[{"name":"Cancer Prevention Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7208-1861","authenticated-orcid":false,"given":"Chuanbo","family":"Xie","sequence":"additional","affiliation":[{"name":"Cancer Prevention Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine Sun Yat\u2010Sen University Cancer Center Guangzhou Guangdong China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhaoyan","family":"Yu","sequence":"additional","affiliation":[{"name":"Center for Mass Spectrometry Research and Clinical Application, and Center for Integrative and Translational Medicine Shandong Public Health Clinical Center Affiliated to Shandong University Jinan Shandong China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,8]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2020-322368"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2016-312288"},{"key":"e_1_2_11_4_1","volume-title":"Population\u2010Based Helicobacter pylori Screen\u2010and\u2010Treat Strategies for Gastric Cancer Prevention: Guidance on Implementation","author":"IARC Working Group 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