Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection
Background/Objectives: The Elecsys<sup>®</sup> 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...
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2024-09-01
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| author | Prooksa Ananchuensook Jongkonnee Wongpiyabovorn Anchalee Avihingsanon Pisit Tangkijvanich |
| author_facet | Prooksa Ananchuensook Jongkonnee Wongpiyabovorn Anchalee Avihingsanon Pisit Tangkijvanich |
| author_sort | Prooksa Ananchuensook |
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| description | Background/Objectives: The Elecsys<sup>®</sup> 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 12–24 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], 96.82–99.97%), 100% (95%CI, 95.39–100%), and 0.998 (95%CI, 0.992–1.003), respectively. The corresponding results for HCV-Ag in determining SVR were 57.14% (95%CI, 20.24–88.19%), 97.41% (95%CI, 93.73–99.04%), and 0.773 (95%CI, 0.543–1.003), respectively. The assay also exhibited comparable sensitivity and specificity between HCV mono- and coinfection. Conclusions: Our study showed that the Elecsys<sup>®</sup> HCV Duo immunoassay effectively diagnosed HCV infection, regardless of HIV status, making it suitable for managing high-risk populations in resource-limited settings. |
| format | Article |
| id | doaj-art-41e667f9af7a4f22831c76fdb527fa37 |
| institution | OA Journals |
| issn | 2075-4418 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | MDPI AG |
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| series | Diagnostics |
| spelling | doaj-art-41e667f9af7a4f22831c76fdb527fa372025-08-20T01:47:42ZengMDPI AGDiagnostics2075-44182024-09-011419217910.3390/diagnostics14192179Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV InfectionProoksa Ananchuensook0Jongkonnee Wongpiyabovorn1Anchalee Avihingsanon2Pisit Tangkijvanich3Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, ThailandDepartment of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, ThailandThe HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, ThailandCenter of Excellence in Hepatitis and Liver Cancer, Department of Biochemistry, Chulalongkorn University, Bangkok 10330, ThailandBackground/Objectives: The Elecsys<sup>®</sup> 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 12–24 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], 96.82–99.97%), 100% (95%CI, 95.39–100%), and 0.998 (95%CI, 0.992–1.003), respectively. The corresponding results for HCV-Ag in determining SVR were 57.14% (95%CI, 20.24–88.19%), 97.41% (95%CI, 93.73–99.04%), and 0.773 (95%CI, 0.543–1.003), respectively. The assay also exhibited comparable sensitivity and specificity between HCV mono- and coinfection. Conclusions: Our study showed that the Elecsys<sup>®</sup> HCV Duo immunoassay effectively diagnosed HCV infection, regardless of HIV status, making it suitable for managing high-risk populations in resource-limited settings.https://www.mdpi.com/2075-4418/14/19/2179Elecsys<sup>®</sup> HCV Duo immunoassaychronic hepatitis C virus (HCV) infectiondirect-acting antivirals (DAAs)sustainedvirological response (SVR)HCV core antigen |
| spellingShingle | Prooksa Ananchuensook Jongkonnee Wongpiyabovorn Anchalee Avihingsanon Pisit Tangkijvanich Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection Diagnostics Elecsys<sup>®</sup> HCV Duo immunoassay chronic hepatitis C virus (HCV) infection direct-acting antivirals (DAAs) sustained virological response (SVR) HCV core antigen |
| title | Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection |
| title_full | Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection |
| title_fullStr | Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection |
| title_full_unstemmed | Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection |
| title_short | Performance of Elecsys<sup>®</sup> HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection |
| title_sort | performance of elecsys sup r sup hcv duo immunoassay for diagnosis and assessment of treatment response in hcv patients with or without hiv infection |
| topic | Elecsys<sup>®</sup> HCV Duo immunoassay chronic hepatitis C virus (HCV) infection direct-acting antivirals (DAAs) sustained virological response (SVR) HCV core antigen |
| url | https://www.mdpi.com/2075-4418/14/19/2179 |
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