{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:11:38Z","timestamp":1791515498819,"version":"4.3.4"},"reference-count":12,"publisher":"Wiley","issue":"15","license":[{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,6,16]],"date-time":"2026-06-16T00:00:00Z","timestamp":1781568000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100009619","name":"Japan Agency for Medical Research and Development","doi-asserted-by":"publisher","award":["JP25fk0210172"],"award-info":[{"award-number":["JP25fk0210172"]}],"id":[{"id":"10.13039\/100009619","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100016545","name":"Roche Diagnostics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016545","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Laboratory Analysis"],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>In Japan, the hepatitis C virus (HCV) care cascade is constrained at the transition from anti\u2010HCV antibody screening to confirmatory HCV ribonucleic acid (HCV RNA) testing in nonspecialist departments. As HCV prevalence declines and the population ages, the two\u2010step antibody\u2010to\u2010RNA algorithm becomes less efficient and vulnerable to loss to follow\u2010up. We evaluated whether the Elecsys HCV Duo assay could function as a triage test to strengthen linkage to care.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a two\u2010part study in Kumamoto Prefecture, Japan. First, a survey of 19 specialized institutions assessed hepatitis virus testing practices and downstream evaluation in nonspecialist departments. Second, 479 serum samples from patients undergoing HCV RNA quantification at four hospitals were prospectively evaluated using the Elecsys HCV Duo assay, with detection rates stratified by viral load.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Nonspecialist departments accounted for 86.6% of in\u2010hospital anti\u2010HCV testing; however, among 1416 anti\u2010HCV\u2013positive individuals identified outside gastroenterology departments, only 22.7% underwent confirmatory HCV RNA testing. In the prospective evaluation of 479 samples, HCVcAg sensitivity and specificity versus HCV RNA were 62.8% and 99.8%, respectively. Detection rates increased with viral load, from 0% at \u2264\u20094.0 log\n                      <jats:sub>10<\/jats:sub>\n                      IU\/mL to 16.7% at 4.1\u20135.5 log\n                      <jats:sub>10<\/jats:sub>\n                      IU\/mL and 86.2% at \u2265\u20095.6 log\n                      <jats:sub>10<\/jats:sub>\n                      IU\/mL.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A vulnerability in the HCV care cascade lies at the transition from screening to confirmatory evaluation in nonspecialist settings. When implemented as a triage test within referral pathways, the Elecsys HCV Duo assay may improve linkage to specialist care while reserving HCV RNA testing for downstream confirmation.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcla.70286","type":"journal-article","created":{"date-parts":[[2026,6,17]],"date-time":"2026-06-17T04:46:20Z","timestamp":1781671580000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Improving Linkage to the\n                    <scp>HCV<\/scp>\n                    Care Cascade in Nonspecialist Settings: Evaluation of the Performance and Triage Utility of the Elecsys\n                    <scp>HCV<\/scp>\n                    Duo Assay in Japan"],"prefix":"10.1002","volume":"40","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7955-1806","authenticated-orcid":false,"given":"Hiroko","family":"Setoyama","sequence":"first","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Faculty of Life Sciences Kumamoto University  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8990-9496","authenticated-orcid":false,"given":"Takehisa","family":"Watanabe","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology, Faculty of Life Sciences Kumamoto University  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiho","family":"Miyase","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Hepatology Kumamoto Shinto General Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masakuni","family":"Tateyama","sequence":"additional","affiliation":[{"name":"National Hospital Organization Kumamoto Medical Center  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiko","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Saiseikai Kumamoto Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhiro","family":"Minami","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Kumamoto Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masato","family":"Sasaki","sequence":"additional","affiliation":[{"name":"Kumamoto Rosai Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunpei","family":"Hashigo","sequence":"additional","affiliation":[{"name":"Kumamoto City Hospital  Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kotaro","family":"Fukubayashi","sequence":"additional","affiliation":[{"name":"Kumamoto Kenhoku Hospital  Kumamoto 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