{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T03:11:28Z","timestamp":1791515488017,"version":"4.3.4"},"reference-count":29,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2024,9,29]],"date-time":"2024-09-29T00:00:00Z","timestamp":1727568000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NSRF","award":["B38G670012"],"award-info":[{"award-number":["B38G670012"]}]},{"name":"NSRF","award":["FF69"],"award-info":[{"award-number":["FF69"]}]},{"name":"Thailand Science Research and Innovation (TSRI) via Chulalongkorn University, and Roche Thailand Ltd.","award":["B38G670012"],"award-info":[{"award-number":["B38G670012"]}]},{"name":"Thailand Science Research and Innovation (TSRI) via Chulalongkorn University, and Roche Thailand Ltd.","award":["FF69"],"award-info":[{"award-number":["FF69"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Diagnostics"],"abstract":"<jats:p>Background\/Objectives: The Elecsys\u00ae HCV Duo immunoassay (Roche Diagnostics International Ltd., Rotkreuz, Switzerland) detects both antibodies to hepatitis C virus (anti-HCV) and HCV core antigen (HCV-Ag) and has shown excellent diagnostic performance in blood donor samples. We aim to validate its use for diagnosing chronic HCV infection and assessing sustained virological response (SVR) post-direct-acting antivirals (DAAs) in patients with or without HIV infection. Methods: Blood samples from 100 healthy controls, as well as 64 HCV mono-infection and 136 HCV-HIV coinfections, were collected before and 12\u201324 weeks after DAAs. The assay performance for determining active infection at baseline and SVR was compared with HCV RNA. Results: Overall, 156 (78.0%) of HCV-infected patients had HCV genotype 1, and the SVR rate was 96.5%. The sensitivity, specificity, and area under the ROC curve (AUROC) for HCV diagnosis at baseline were 99.50% (95% confidence interval [CI], 96.82\u201399.97%), 100% (95%CI, 95.39\u2013100%), and 0.998 (95%CI, 0.992\u20131.003), respectively. The corresponding results for HCV-Ag in determining SVR were 57.14% (95%CI, 20.24\u201388.19%), 97.41% (95%CI, 93.73\u201399.04%), and 0.773 (95%CI, 0.543\u20131.003), respectively. The assay also exhibited comparable sensitivity and specificity between HCV mono- and coinfection. Conclusions: Our study showed that the Elecsys\u00ae HCV Duo immunoassay effectively diagnosed HCV infection, regardless of HIV status, making it suitable for managing high-risk populations in resource-limited settings.<\/jats:p>","DOI":"10.3390\/diagnostics14192179","type":"journal-article","created":{"date-parts":[[2024,9,30]],"date-time":"2024-09-30T04:00:04Z","timestamp":1727668804000},"page":"2179","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Performance of Elecsys\u00ae HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7513-7245","authenticated-orcid":false,"given":"Prooksa","family":"Ananchuensook","sequence":"first","affiliation":[{"name":"Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand"},{"name":"Academic Affair, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jongkonnee","family":"Wongpiyabovorn","sequence":"additional","affiliation":[{"name":"Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3222-9611","authenticated-orcid":false,"given":"Anchalee","family":"Avihingsanon","sequence":"additional","affiliation":[{"name":"The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2926-8671","authenticated-orcid":false,"given":"Pisit","family":"Tangkijvanich","sequence":"additional","affiliation":[{"name":"Center of Excellence in Hepatitis and Liver Cancer, Department of Biochemistry, Chulalongkorn University, Bangkok 10330, Thailand"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,29]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"S58","DOI":"10.1016\/j.jhep.2014.07.012","article-title":"Natural history of hepatitis C","volume":"61","author":"Westbrook","year":"2014","journal-title":"J. Hepatol."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"637","DOI":"10.7326\/M16-2575","article-title":"Oral Direct-Acting Agent Therapy for Hepatitis C Virus Infection: A Systematic Review","volume":"166","author":"Nelson","year":"2017","journal-title":"Ann. Intern. Med."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"1421","DOI":"10.3748\/wjg.v22.i4.1421","article-title":"New approaches in the treatment of hepatitis C","volume":"22","year":"2016","journal-title":"World J. Gastroenterol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"254","DOI":"10.1002\/cld.978","article-title":"Hepatitis C Virus Elimination by 2030: Conquering Mount Improbable","volume":"16","author":"Dhiman","year":"2020","journal-title":"Clin. Liver Dis."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"1451","DOI":"10.1016\/S0140-6736(19)32320-7","article-title":"Hepatitis C","volume":"394","author":"Spearman","year":"2019","journal-title":"Lancet"},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"101626","DOI":"10.1016\/j.clinre.2021.101626","article-title":"HCV virology and diagnosis","volume":"45","author":"Roger","year":"2021","journal-title":"Clin. Res. Hepatol. Gastroenterol."},{"key":"ref_7","doi-asserted-by":"crossref","unstructured":"(2020). EASL recommendations on treatment of hepatitis C: Final update of the series(\u2606). J. Hepatol., 73, 1170\u20131218.","DOI":"10.1016\/j.jhep.2020.08.018"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"686","DOI":"10.1002\/hep.31060","article-title":"Hepatitis C Guidance 2019 Update: American Association for the Study of Liver Diseases-Infectious Diseases Society of America Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection","volume":"71","author":"Ghany","year":"2020","journal-title":"Hepatology"},{"key":"ref_9","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":"Benito","year":"2018","journal-title":"Diagn. Microbiol. Infect. Dis."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"92","DOI":"10.1016\/j.jcv.2004.10.005","article-title":"The role of core antigen detection in management of hepatitis C: A critical review","volume":"32","author":"Seme","year":"2005","journal-title":"J. Clin. Virol."},{"key":"ref_11","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":"Wang","year":"2021","journal-title":"J. Clin. Lab. Anal."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"2489","DOI":"10.1111\/trf.13179","article-title":"Sensitivity of hepatitis C virus core antigen and antibody combination assays in a global panel of window period samples","volume":"55","author":"Laperche","year":"2015","journal-title":"Transfusion"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"263","DOI":"10.1093\/cid\/ciu782","article-title":"Hepatitis C core antigen testing: A reliable, quick, and potentially cost-effective alternative to hepatitis C polymerase chain reaction in diagnosing acute hepatitis C virus infection","volume":"60","author":"Cresswell","year":"2015","journal-title":"Clin. Infect. Dis."},{"key":"ref_14","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":"Majchrzak","year":"2022","journal-title":"J. Clin. Virol."},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"305","DOI":"10.3851\/IMP3370","article-title":"Efficacy of elbasvir\/grazoprevir therapy in HCV genotype-1 with or without HIV infection: Role of HCV core antigen monitoring and improvement of liver stiffness and steatosis","volume":"25","author":"Chayanupatkul","year":"2020","journal-title":"Antivir. Ther."},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"258","DOI":"10.1016\/j.kjms.2010.11.007","article-title":"Performance characteristics of a combined hepatitis C virus core antigen and anti-hepatitis C virus antibody test in different patient groups","volume":"27","author":"Yang","year":"2011","journal-title":"Kaohsiung J. Med. Sci."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"119","DOI":"10.1016\/j.jviromet.2014.01.002","article-title":"Screening for hepatitis C virus infection in a high prevalence country by an antigen\/antibody combination assay versus a rapid test","volume":"199","author":"Tagny","year":"2014","journal-title":"J. Virol. Methods"},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1179\/acb.2010.053","article-title":"Evaluation of the use of a combined HCV antigen\/antibody assay in routine laboratory practice","volume":"65","author":"Vermeersch","year":"2010","journal-title":"Acta Clin. Belg."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1007\/s00284-011-0046-7","article-title":"Comparison of monolisa HCV Ag\/Ab ULTRA with two anti-HCV assays for the detection of HCV infection in hospital setting","volume":"64","author":"Yagci","year":"2012","journal-title":"Curr. Microbiol."},{"key":"ref_20","doi-asserted-by":"crossref","first-page":"343","DOI":"10.4314\/ejhs.v24i4.10","article-title":"Evaluation of an antigen-antibody \u201ccombination\u201d enzyme linked immunosorbent assay for diagnosis of hepatitis C virus infections","volume":"24","author":"Odari","year":"2014","journal-title":"Ethiop. J. Health Sci."},{"key":"ref_21","doi-asserted-by":"crossref","unstructured":"Ponnuvel, S., Prakash, A., Steve, R.J., Doss, G.P., Goel, A., Zachariah, U.G., Eapen, C.E., Rebekah, G., Kannangai, R., and Fletcher, G.J. (2023). Longitudinal assessment of HCV core antigen kinetics to monitor therapeutic response in the age of DAAs. PLoS ONE, 18.","DOI":"10.1371\/journal.pone.0282013"},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"856","DOI":"10.1016\/S2468-1253(18)30271-1","article-title":"HCV core antigen as an alternative to HCV RNA testing in the era of direct-acting antivirals: Retrospective screening and diagnostic cohort studies","volume":"3","author":"Wong","year":"2018","journal-title":"Lancet. Gastroenterol. Hepatol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"190","DOI":"10.1080\/09674845.2019.1654790","article-title":"Hepatitis C virus core antigen as a possible alternative for evaluation of treatment effectiveness after treatment with direct-acting antivirals","volume":"76","author":"Tomasiewicz","year":"2019","journal-title":"Br. J. Biomed. Sci."},{"key":"ref_24","doi-asserted-by":"crossref","first-page":"29","DOI":"10.1016\/j.diagmicrobio.2017.06.006","article-title":"Hepatitis C virus core antigen in the management of patients treated with new direct-acting antivirals","volume":"89","author":"Arboledas","year":"2017","journal-title":"Diagn. Microbiol. Infect. Dis."},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"1729","DOI":"10.1080\/14656566.2021.1921737","article-title":"An update on direct antiviral agents for the treatment of hepatitis C","volume":"22","author":"Stanciu","year":"2021","journal-title":"Expert Opin. Pharmacother."},{"key":"ref_26","doi-asserted-by":"crossref","first-page":"345","DOI":"10.7326\/M16-0065","article-title":"Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection: A Systematic Review and Meta-analysis","volume":"165","author":"Freiman","year":"2016","journal-title":"Ann. Intern. Med."},{"key":"ref_27","doi-asserted-by":"crossref","first-page":"S316","DOI":"10.1093\/infdis\/jiad453","article-title":"What Is Needed to Move Toward Single-Step Diagnosis of Current HCV Infection?","volume":"229","author":"Feld","year":"2024","journal-title":"J. Infect. Dis."},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"S328","DOI":"10.1093\/infdis\/jiad269","article-title":"What Hepatitis C Virus (HCV) Diagnostic Tools Are Needed to Advance Diagnosis of Current HCV Infection in Outreach Settings and in a Nonclinical Setting?","volume":"229","author":"Page","year":"2024","journal-title":"J. Infect. Dis."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"S350","DOI":"10.1093\/infdis\/jiad199","article-title":"Opportunities for Enhanced Prevention and Control of Hepatitis C Through Improved Screening and Testing Efforts","volume":"229","author":"Cartwright","year":"2024","journal-title":"J. Infect. Dis."}],"container-title":["Diagnostics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/19\/2179\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T16:07:05Z","timestamp":1760112425000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2075-4418\/14\/19\/2179"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,9,29]]},"references-count":29,"journal-issue":{"issue":"19","published-online":{"date-parts":[[2024,10]]}},"alternative-id":["diagnostics14192179"],"URL":"https:\/\/doi.org\/10.3390\/diagnostics14192179","relation":{},"ISSN":["2075-4418"],"issn-type":[{"value":"2075-4418","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,9,29]]}}}