{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T20:05:48Z","timestamp":1792785948642,"version":"4.5.0"},"reference-count":16,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"name":"Japan Society for the Promotion of Science-Grants-in-Aid for Scientific Research","award":["22H03963"],"award-info":[{"award-number":["22H03963"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Japan Society for the Promotion of Science-Grants-in-Aid for Scientific Research","award":["20H05877"],"award-info":[{"award-number":["20H05877"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Japan Society for the Promotion of Science-Grants-in-Aid for Scientific Research","award":["25K22895"],"award-info":[{"award-number":["25K22895"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Japan Society for the Promotion of Science-Grants-in-Aid for Scientific Research","award":["24KK0208"],"award-info":[{"award-number":["24KK0208"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"crossref"}]},{"name":"Japan Society for the Promotion of Science Fellows","award":["24KJ0230"],"award-info":[{"award-number":["24KJ0230"]}],"id":[{"id":"https:\/\/ror.org\/00hhkn466","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>There is an unmet need for a rapid, affordable, and highly sensitive point-of-care for heaptitis C virus (HCV) antigens detection suitable for decentralized settings. We developed SMART-C, a lateral-flow assay integrating a thermo-responsive smart polymer for HCV antigen extraction and enrichment with colloidal gold nanoparticles. We evaluated its diagnostic performance against the Cobas\u00ae 6800 HCV RNA PCR assay as the reference standard.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A multinational, multicentre, prospective diagnostic accuracy study was conducted during 2022\u20132026 at hospital and field sites in Egypt, Pakistan, and Japan. Paired serum\/plasma samples from venous blood were tested blindly using SMART-C and quantitative HCV RNA PCR. Sensitivity, specificity, accuracy, positive predictive value (PPV), and negative predictive value (NPV) were calculated following STARD guidelines. Additionally, 21 patients initiating direct-acting antiviral (DAA) therapy were prospectively followed to assess SMART-C performance during treatment and after viral clearance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Among 1353 paired samples from a high-risk clinical cohort, SMART-C demonstrated 94.6% sensitivity (474\/501; 95% CI, 92.3\u201396.3) and 91.3% specificity (778\/852; 95% CI, 89.2\u201393.0), with 92.5% accuracy, 86.5% PPV, and 96.6% NPV. Agreement with PCR was high (\u03ba = 0.843). SMART-C paralleled PCR-defined viral decline during DAA therapy and became negative concordantly with PCR clearance in 19\/21 patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>SMART-C achieved an analytical limit of detection below 10\u2005IU\/mL, approaching that of the Cobas\u00ae 6800 PCR assay (approximately 10\u2005IU\/mL). Its high diagnostic performance and simple lateral-flow format support its potential for decentralized HCV testing and contribution to WHO hepatitis C elimination goals.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiag450","type":"journal-article","created":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T11:22:46Z","timestamp":1788780166000},"source":"Crossref","is-referenced-by-count":0,"title":["A Novel Decentralized Rapid Test for Detection of Hepatitis C virus Antigens Using Smart Polymer Technology: A Prospective Multinational Study"],"prefix":"10.1093","author":[{"given":"Gamal","family":"Shiha","sequence":"first","affiliation":[{"name":"Gastroenterology and Hepatology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University , Mansoura ,","place":["Egypt"]},{"name":"Gastroentrology and Hepatology Department, Egyptian Liver Research Institute and Hospital (ELRIAH) , Sherbin, El Mansoura ,","place":["Egypt"]},{"name":"Technical Institute of Nursing Internal Medicine Department, , Sherbin ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7906-0350","authenticated-orcid":false,"given":"Mitsuhiro","family":"Ebara","sequence":"additional","affiliation":[{"name":"Research Center for Macromolecules and Biomaterials, National Institute for Materials Science (NIMS) , Tsukuba, Ibaraki ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayman","family":"Hassan","sequence":"additional","affiliation":[{"name":"Gastroentrology and Hepatology Department, Egyptian Liver Research Institute and Hospital (ELRIAH) , Sherbin, El Mansoura ,","place":["Egypt"]},{"name":"Medical Laboratories Department, Higher Technological Institute of Applied Health Sciences , Sherbin, Mansoura ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1652-6168","authenticated-orcid":false,"given":"Hidenori","family":"Toyoda","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital , Ogaki ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohamed","family":"Abdel-Samiee","sequence":"additional","affiliation":[{"name":"Hepatology and Gastroenterology Department, National Liver Institute, Menoufia University , Shebin El-kom ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yosra","family":"Osama Khalifa","sequence":"additional","affiliation":[{"name":"Hepatology and Gastroenterology Department, National Liver Institute, Menoufia University , Shebin El-kom ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hossam A","family":"Galbt","sequence":"additional","affiliation":[{"name":"Clinical Pathology Department, National Liver Institute, Menoufia University, Shebin El-Kom ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eman","family":"Abdelsameea","sequence":"additional","affiliation":[{"name":"Hepatology and Gastroenterology Department, National Liver Institute, Menoufia University , Shebin El-kom ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-3609-4205","authenticated-orcid":false,"given":"Ahmed","family":"Farahat","sequence":"additional","affiliation":[{"name":"Gastroenterology and Hepatology Unit, Internal Medicine Department, Faculty of Medicine, Mansoura University , Mansoura ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dina H","family":"Ziada","sequence":"additional","affiliation":[{"name":"Tropical Medicine and Infectious Disease Department, Faculty of Medicine, Tanta University , Tanta ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Madonna","family":"Magdy Fahmy","sequence":"additional","affiliation":[{"name":"Tropical Medicine and Infectious Disease Department, Faculty of Medicine, Tanta University , Tanta ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Asad","family":"Ali Choudhry","sequence":"additional","affiliation":[{"name":"PARSA Trust Liver Clinic Gastroentrology and Hepatology Department, , Gujranwala ,","place":["Pakistan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-1926-8607","authenticated-orcid":false,"given":"Auj","family":"Chaudhry","sequence":"additional","affiliation":[{"name":"PARSA Trust Liver Clinic Gastroentrology and Hepatology Department, , Gujranwala ,","place":["Pakistan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hafsa","family":"Asad","sequence":"additional","affiliation":[{"name":"PARSA Trust Liver Clinic Gastroentrology and Hepatology Department, , Gujranwala ,","place":["Pakistan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5617-4726","authenticated-orcid":false,"given":"Ahmed","family":"Nabil","sequence":"additional","affiliation":[{"name":"Research Center for Macromolecules and Biomaterials, National Institute for Materials Science (NIMS) , Tsukuba, Ibaraki ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gaston","family":"Picchio","sequence":"additional","affiliation":[{"name":"Independent Free-Lance Consultant , Flemington, New Jersey ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riham","family":"Soliman","sequence":"additional","affiliation":[{"name":"Gastroentrology and Hepatology Department, Egyptian Liver Research Institute and Hospital (ELRIAH) , Sherbin, El Mansoura ,","place":["Egypt"]},{"name":"Technical Institute of Nursing Internal Medicine Department, , Sherbin ,","place":["Egypt"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,9,17]]},"reference":[{"key":"2026092919364156500_jiag450-B1","volume-title":"Combating hepatitis B and C to reach elimination by 2030: advocacy brief","author":"WHO","year":"2016"},{"key":"2026092919364156500_jiag450-B2","volume-title":"Global health sector strategy on viral hepatitis 2016\u20132021: towards ending viral hepatitis","author":"World Health Organization","year":"2016"},{"key":"2026092919364156500_jiag450-B3","doi-asserted-by":"crossref","first-page":"142","DOI":"10.1053\/j.gastro.2016.09.009","article-title":"Eradication of hepatitis C virus infection in patients with cirrhosis reduces risk of liver and non-liver 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