{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T06:42:46Z","timestamp":1790232166049,"version":"4.1.0"},"reference-count":27,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2025,12,10]],"date-time":"2025-12-10T00:00:00Z","timestamp":1765324800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["1U01CA292771"],"award-info":[{"award-number":["1U01CA292771"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U54 EB027049"],"award-info":[{"award-number":["U54 EB027049"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U54EB007958"],"award-info":[{"award-number":["U54EB007958"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["U19AI159822"],"award-info":[{"award-number":["U19AI159822"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]},{"name":"National Institute of Biomedical Engineering"},{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,5,15]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hepatitis C virus (HCV) infection is a major public health problem despite the availability of highly effective and curative direct-acting antiviral treatments. Low diagnostic rates, driven in part by a 2-step diagnostic process and the need for molecular confirmation, pose a significant barrier to timely treatment. Here we describe the development, analytical characterization, and a preliminary clinical validation study of a rapid, user-friendly, sensitive, qualitative molecular test for point-of-care HCV testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This study evaluated the analytical performance of a 15-minute time to result qualitative molecular test for HCV on the sample-to-answer point-of-care DASH Rapid PCR System. The dynamic range, limit of detection, analytical specificity, and the equivalent detection of genotypes 1\u20136 were assessed. A small clinical validation study was independently conducted by Johns Hopkins University investigators using retrospectively collected specimens.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The Research Use Only DASH HCV assay has wide dynamic range, can detect HCV genotypes 1\u20136, and has a detection limit of 200\u2005IU\/mL with 100\u2005\u03bcL specimen volume addition. In a preliminary study of 97 plasma specimens, the DASH HCV assay demonstrated 100% positive percent agreement and 100% negative percent agreement when compared to commercial platforms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The DASH HCV test holds potential to enable same-day diagnosis and treatment in support of HCV elimination efforts.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/infdis\/jiaf608","type":"journal-article","created":{"date-parts":[[2025,12,3]],"date-time":"2025-12-03T13:19:28Z","timestamp":1764767968000},"page":"823-830","source":"Crossref","is-referenced-by-count":5,"title":["Development of a Rapid Automated Point-of-Care Test for Hepatitis C Viral RNA on the DASH Rapid Polymerase Chain Reaction System"],"prefix":"10.1093","volume":"233","author":[{"given":"Jennifer L","family":"Reed","sequence":"first","affiliation":[{"name":"Center for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine , Chicago, Illinois ,","place":["USA"]},{"name":"Department of Biomedical Engineering, Northwestern University , Evanston, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew A","family":"Butzler","sequence":"additional","affiliation":[{"name":"Center for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine , Chicago, Illinois ,","place":["USA"]},{"name":"Department of Biomedical Engineering, Northwestern University , Evanston, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia A","family":"Hawkins","sequence":"additional","affiliation":[{"name":"Center for Global Communicable and Emerging Infectious Diseases, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine , Chicago, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8619-5598","authenticated-orcid":false,"given":"Yukari C","family":"Manabe","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Holden","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David L","family":"Thomas","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9331-2462","authenticated-orcid":false,"given":"Andrea L","family":"Cox","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine , Baltimore, Maryland ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5554-6615","authenticated-orcid":false,"given":"Sally M","family":"McFall","sequence":"additional","affiliation":[{"name":"Center for Innovation in Global Health Technologies, Robert J. Havey Institute for Global Health, Northwestern University Feinberg School of Medicine , Chicago, Illinois ,","place":["USA"]},{"name":"Department of Biomedical Engineering, Northwestern University , Evanston, Illinois ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2025,12,10]]},"reference":[{"key":"2026051419574451700_jiaf608-B1","doi-asserted-by":"crossref","first-page":"1270","DOI":"10.1086\/423943","article-title":"Clearance of hepatitis C virus after newly acquired infection in injection drug users","volume":"190","author":"Jauncey","year":"2004","journal-title":"J Infect Dis"},{"key":"2026051419574451700_jiaf608-B2","author":"World Health Organization"},{"key":"2026051419574451700_jiaf608-B3","first-page":"3","article-title":"HIV and hepatitis testing: global progress, challenges, and future directions","volume":"18","author":"Easterbrook","year":"2016","journal-title":"AIDS Rev"},{"key":"2026051419574451700_jiaf608-B4","doi-asserted-by":"crossref","first-page":"186","DOI":"10.4254\/wjh.v10.i2.186","article-title":"Hepatitis C virus: morphogenesis, infection and therapy","volume":"10","author":"Morozov","year":"2018","journal-title":"World J Hepatol"},{"key":"2026051419574451700_jiaf608-B5","doi-asserted-by":"crossref","first-page":"e0224751","DOI":"10.1371\/journal.pone.0224751","article-title":"Utility of the new cobas HCV test for viral load monitoring during direct-acting antiviral therapy","volume":"14","author":"M\u00fccke","year":"2019","journal-title":"PLoS One"},{"key":"2026051419574451700_jiaf608-B6","doi-asserted-by":"crossref","first-page":"253","DOI":"10.1016\/S2468-1253(22)00346-6","article-title":"Impact of hepatitis C virus point-of-care RNA viral load testing compared with laboratory-based testing on uptake of RNA testing and treatment, and turnaround times: a systematic review and meta-analysis","volume":"8","author":"Trickey","year":"2023","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"2026051419574451700_jiaf608-B7"},{"key":"2026051419574451700_jiaf608-B8","volume-title":"WHO guidelines approved by the guidelines review committee. 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