{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:11:27Z","timestamp":1791515487669,"version":"4.3.4"},"reference-count":32,"publisher":"Public Library of Science (PLoS)","issue":"11","license":[{"start":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T00:00:00Z","timestamp":1731888000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016545","name":"Roche Diagnostics","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100016545","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Center of Excellence in Clinical Virology, Chulalongkorn University"},{"name":"the King Chulalongkorn Memorial Hospital"},{"name":"the Second Century Fund (C2F), Chulalongkorn University (TH)."}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS ONE"],"abstract":"<jats:p>Hepatitis C virus (HCV) infection can cause acute and chronic hepatitis, leading to liver cirrhosis and hepatocellular carcinoma. The World Health Organization aims to eliminate viral hepatitis by 2030 through extensive screening and treatment. To achieve this goal, comprehensive and widespread screening is essential for diagnosis and treatment. This study aims to evaluate the diagnostic sensitivity and specificity of the Elecsys<jats:sup>\u00ae<\/jats:sup> HCV Duo immunoassay (Duo-assay), which simultaneously detects anti-HCV antibodies (Duo\/anti-HCV) and HCV core antigen (Duo\/HCVcAg) in a single sample, compared with initially antibody testing followed by quantitative real-time polymerase chain reaction (qRT-PCR). Additionally, this study aimed to evaluate a relationship between Duo\/HCVcAg and qRT-PCR assay in different genotypes. A total of 769 plasma samples were tested using the Duo-assay to further evaluate the test\u2019s performance and conduct Duo\/HCVcAg correlation analysis using qRT-PCR for each genotype. Among the active infection group (anti-HCV+\/RNA+; n = 473), the Duo-assay showed 100% sensitivity for detecting Duo\/anti-HCV and 70.6% for Duo\/HCVcAg. In the resolved infection group (anti-HCV+\/RNA\u2013; n = 176), the assay showed 100% sensitivity for Duo\/anti-HCV and 100% specificity for Duo\/HCVcAg. In the non-infected group (anti-HCV\u2013\/RNA\u2013; n = 120), the assay showed 100% specificity for both Duo\/anti-HCV and Duo\/HCVcAg. Moreover, no correlation was observed between the Duo\/HCVcAg and HCV RNA tests, irrespective of genotype. These findings indicate that the Duo-assay is highly sensitive for detecting anti-HCV and specifically identifies patients with active infection. Nevertheless, cases with anti-HCV+\/HCVcAg\u2013results should undergo additional confirmation with western blot\/immunoblot and qRT-PCR to ensure diagnostic accuracy, especially in Blood donation facilities.<\/jats:p>","DOI":"10.1371\/journal.pone.0313771","type":"journal-article","created":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T18:21:52Z","timestamp":1731954112000},"page":"e0313771","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":12,"title":["Comparison of anti-HCV combined with HCVcAg (Elecsys HCV Duo immunoassay) and anti-HCV rapid test followed by HCV RNA analysis using qRT-PCR to identify active infection for treatment"],"prefix":"10.1371","volume":"19","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9482-6353","authenticated-orcid":true,"given":"Sitthichai","family":"Kanokudom","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kittiyod","family":"Poovorawan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pornjarim","family":"Nilyanimit","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nungruthai","family":"Suntronwong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ratchadawan","family":"Aeemjinda","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sittisak","family":"Honsawek","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2337-6807","authenticated-orcid":true,"given":"Yong","family":"Poovorawan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"340","published-online":{"date-parts":[[2024,11,18]]},"reference":[{"key":"pone.0313771.ref001","unstructured":"World Health Organization (WHO) [Internet]. Hepatitis. [cited 2024 August 15]. https:\/\/www.who.int\/health-topics\/hepatitis#tab=tab_1."},{"key":"pone.0313771.ref002","doi-asserted-by":"crossref","first-page":"286","DOI":"10.1016\/S2468-1253(23)00408-9","article-title":"WHO hepatitis C elimination targets: the global equity challenge","volume":"9","author":"K Heath","year":"2024","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"pone.0313771.ref003","unstructured":"World Health Organization (WHO) [Internet]. Hepatitis C (updated on 2024 April 9). [cited 2024 August 15]. https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/hepatitis-c."},{"key":"pone.0313771.ref004","doi-asserted-by":"crossref","first-page":"522","DOI":"10.1111\/liv.14324","article-title":"Global timing of hepatitis C virus elimination in high-income countries","volume":"40","author":"H Razavi","year":"2020","journal-title":"Liver Int"},{"key":"pone.0313771.ref005","doi-asserted-by":"crossref","first-page":"346","DOI":"10.1016\/S2468-1253(23)00321-7","article-title":"Progress towards elimination of viral hepatitis: a lancet gastroenterology & hepatology commission update","volume":"9","author":"GS Cooke","year":"2024","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"pone.0313771.ref006","doi-asserted-by":"crossref","first-page":"S198","DOI":"10.1093\/infdis\/jiac490","article-title":"Simplified test-to-treat strategy for hepatitis C in Thailand: the Phetchabun model","volume":"228","author":"R Wasitthankasem","year":"2023","journal-title":"J Infect Dis"},{"key":"pone.0313771.ref007","doi-asserted-by":"crossref","first-page":"175","DOI":"10.4269\/ajtmh.19-0817","article-title":"Prevalence of hepatitis C virus in an endemic area of Thailand: burden assessment toward HCV elimination","volume":"103","author":"R Wasitthankasem","year":"2020","journal-title":"Am J Trop Med Hyg"},{"key":"pone.0313771.ref008","doi-asserted-by":"crossref","first-page":"7348755","DOI":"10.1155\/2022\/7348755","article-title":"Performance of HCV antigen testing for the diagnosis and monitoring of antiviral treatment: a systematic review and meta-analysis","volume":"2022","author":"GL Flores","year":"2022","journal-title":"BioMed Res Int"},{"key":"pone.0313771.ref009","doi-asserted-by":"crossref","first-page":"e0268728","DOI":"10.1371\/journal.pone.0268728","article-title":"Qualitative hepatitis C virus RNA assay identifies active infection with sufficient viral load for treatment amon Phetchabun residents in Thailand.g","volume":"18","author":"P Pratedrat","year":"2023","journal-title":"PLOS ONE"},{"key":"pone.0313771.ref010","unstructured":"National Health Security Office of Thailand (NHSO) [Internet]. Payment for Public Health Services for Hepatitis C Treatment -issue No. 2 (updated on 2023 September 19) [cited 2024 October 23]. https:\/\/www.nhso.go.th\/storage\/downloads\/main\/233\/39_%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8%A8%E0%B8%81%E0%B8%B2%E0%B8%A3%E0%B8%88%E0%B9%88%E0%B8%B2%E0%B8%A2%E0%B9%84%E0%B8%A7%E0%B8%A3%E0%B8%B1%E0%B8%AA%E0%B8%95%E0%B8%B1%E0%B8%9A%E0%B8%AD%E0%B8%B1%E0%B8%81%E0%B9%80%E0%B8%AA%E0%B8%9A%E0%B8%8B%E0%B8%B5_%E0%B8%89.2_2566_.pdf."},{"key":"pone.0313771.ref011","unstructured":"Minstry of Public Health of Thailand (MOPH) [internet]. Thailand Practice Guideline for Eliminate Hepatitis C (updated 2022 May) [cited 2024 October 23]. https:\/\/ddc.moph.go.th\/uploads\/publish\/1032520200721094236.pdf."},{"key":"pone.0313771.ref012","unstructured":"Roche Diagnostics GmbH [Internet]. Elecsys\u00ae HCV Duo (Mat. No. 08110697190). method sheet, V1; 2021\u201306. [cited 2024 August 15]. https:\/\/diagnostics.roche.com\/global\/en\/products\/params\/elecsys-hcv-duo.html."},{"key":"pone.0313771.ref013","doi-asserted-by":"crossref","first-page":"105293","DOI":"10.1016\/j.jcv.2022.105293","article-title":"Multicenter performance evaluation of the Elecsys HCV Duo immunoassay","volume":"156","author":"M Majchrzak","year":"2022","journal-title":"J Clin Virol"},{"key":"pone.0313771.ref014","doi-asserted-by":"crossref","first-page":"e0287694","DOI":"10.1371\/journal.pone.0287694","article-title":"An amino acid substitution in HCV core antigen limits its use as a reliable measure of HCV infection compared with HCV RNA","volume":"18","author":"P Hansoongnern","year":"2023","journal-title":"PLOS ONE"},{"key":"pone.0313771.ref015","doi-asserted-by":"crossref","first-page":"e22632","DOI":"10.1002\/jcla.22632","article-title":"The correlation of HCV RNA and HCV core antigen in different genotypes of HCV","volume":"33","author":"Y Xiang","year":"2018","journal-title":"J Clin Lab Anal"},{"key":"pone.0313771.ref016","doi-asserted-by":"crossref","first-page":"e0267102","DOI":"10.1371\/journal.pone.0267102","article-title":"Long-term persistence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein-specific and neutralizing antibodies in recovered COVID-19 patients","volume":"17","author":"J Chansaenroj","year":"2022","journal-title":"PLOS ONE"},{"key":"pone.0313771.ref017","doi-asserted-by":"crossref","first-page":"21446","DOI":"10.7448\/IAS.20.1.21446","article-title":"HCV Ag quantification as a one-step procedure in diagnosing chronic hepatitis C infection in Cameroon: the ANRS 12336 study","volume":"20","author":"L Duchesne","year":"2017","journal-title":"J Int AIDS Soc"},{"key":"pone.0313771.ref018","doi-asserted-by":"crossref","first-page":"373","DOI":"10.1007\/s13337-019-00542-5","article-title":"Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody","volume":"30","author":"S Mahajan","year":"2019","journal-title":"VirusDisease"},{"key":"pone.0313771.ref019","doi-asserted-by":"crossref","first-page":"1534","DOI":"10.4269\/ajtmh.21-1016","article-title":"Prescreening with a rapid diagnostic test followed by a confirmatory qualitative nucleic acid test can simplify hepatitis C diagnosis","volume":"106","author":"R Wasitthankasem","year":"2022","journal-title":"Am J Trop Med Hyg"},{"key":"pone.0313771.ref020","doi-asserted-by":"crossref","first-page":"126","DOI":"10.1016\/j.diagmicrobio.2018.01.021","article-title":"Hepatitis C virus core antigen for screening organ donors and recipients","volume":"91","author":"R Benito","year":"2018","journal-title":"Diagn Microbiol Infect Dis"},{"key":"pone.0313771.ref021","doi-asserted-by":"crossref","first-page":"e23755","DOI":"10.1002\/jcla.23755","article-title":"HCV core antigen plays an important role in the fight against HCV as an alternative to HCV-RNA detection","volume":"35","author":"Y Wang","year":"2021","journal-title":"J Clin Lab Anal"},{"key":"pone.0313771.ref022","doi-asserted-by":"crossref","first-page":"1498","DOI":"10.21873\/invivo.13234","article-title":"HCV core-antigen assay as an effective alternative to HCV RNA quantification in patients with hepatitis C","volume":"37","author":"R Vieira","year":"2023","journal-title":"In Vivo"},{"key":"pone.0313771.ref023","doi-asserted-by":"crossref","first-page":"e4008","DOI":"10.7717\/peerj.4008","article-title":"HCV core antigen is an alternative marker to HCV RNA for evaluating active HCV infection: implications for improved diagnostic option in an era of affordable DAAs","volume":"5","author":"R Wasitthankasem","year":"2017","journal-title":"PeerJ"},{"key":"pone.0313771.ref024","doi-asserted-by":"crossref","first-page":"S45","DOI":"10.1016\/j.jhep.2014.07.027","article-title":"Global epidemiology and genotype distribution of the hepatitis C virus infection","volume":"61","author":"E Gower","year":"2014","journal-title":"J Hepatol"},{"key":"pone.0313771.ref025","doi-asserted-by":"crossref","first-page":"e0212033","DOI":"10.1371\/journal.pone.0212033","article-title":"Nine-year distribution pattern of hepatitis C virus (HCV) genotypes in Southern Italy","volume":"14","author":"A Petruzziello","year":"2019","journal-title":"PLOS ONE"},{"key":"pone.0313771.ref026","doi-asserted-by":"crossref","first-page":"7824","DOI":"10.3748\/wjg.v22.i34.7824","article-title":"Global epidemiology of hepatitis C virus infection: an up-date of the distribution and circulation of hepatitis C virus genotypes","volume":"22","author":"A Petruzziello","year":"2016","journal-title":"World J Gastroenterol"},{"key":"pone.0313771.ref027","doi-asserted-by":"crossref","first-page":"e33","DOI":"10.1016\/j.ijid.2012.05.086","article-title":"Epidemiology of hepatitis C virus -genotypes 1 through 6 in Asia and the world","volume":"16","author":"Y. Poovorawan","year":"2012","journal-title":"Int J Infect Dis"},{"key":"pone.0313771.ref028","doi-asserted-by":"crossref","first-page":"e0126764","DOI":"10.1371\/journal.pone.0126764","article-title":"Genotypic distribution of hepatitis C virus in Thailand and Southeast Asia","volume":"10","author":"R Wasitthankasem","year":"2015","journal-title":"PLOS ONE"},{"key":"pone.0313771.ref029","doi-asserted-by":"crossref","first-page":"533","DOI":"10.1038\/s41575-022-00608-8","article-title":"Breakthroughs in hepatitis C research: from discovery to cure","volume":"19","author":"MP Manns","year":"2022","journal-title":"Nat Rev Gastroenterol Hepatol"},{"key":"pone.0313771.ref030","doi-asserted-by":"crossref","first-page":"527030","DOI":"10.1155\/2014\/527030","article-title":"Factors associated with spontaneous clearance of hepatitis C virus in Chinese population","volume":"2014","author":"F Kong","year":"2014","journal-title":"BioMed Res Int"},{"key":"pone.0313771.ref031","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1111\/j.1365-2893.2005.00651.x","article-title":"Spontaneous viral clearance following acute hepatitis C infection: a systematic review of longitudinal studies","volume":"13","author":"JM Micallef","year":"2006","journal-title":"J Viral Hepat"},{"key":"pone.0313771.ref032","unstructured":"The National Health Service (NHS) [Internet]. Treatment-hepatitis C (last updated 2021 October 27). [cited 2024 August 15]. https:\/\/www.nhs.uk\/conditions\/hepatitis-c\/treatment\/."}],"container-title":["PLOS ONE"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0313771","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,11,18]],"date-time":"2024-11-18T18:22:09Z","timestamp":1731954129000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0313771"}},"subtitle":[],"editor":[{"given":"Gheyath K.","family":"Nasrallah","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2024,11,18]]},"references-count":32,"journal-issue":{"issue":"11","published-online":{"date-parts":[[2024,11,18]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0313771","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,11,18]]}}}