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Open AccessBrief Report
Performance of Elecsys® HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection
by
Prooksa Ananchuensook
Prooksa Ananchuensook 1,2,
Jongkonnee Wongpiyabovorn
Jongkonnee Wongpiyabovorn 3,
Anchalee Avihingsanon
Anchalee Avihingsanon 4 and
Pisit Tangkijvanich
Pisit Tangkijvanich 5,*
1
Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
2
Academic Affair, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
3
Department of Microbiology, Faculty of Medicine, Chulalongkorn University, Bangkok 10330, Thailand
4
The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok 10330, Thailand
5
Center of Excellence in Hepatitis and Liver Cancer, Department of Biochemistry, Chulalongkorn University, Bangkok 10330, Thailand
*
Author to whom correspondence should be addressed.
Diagnostics 2024, 14(19), 2179; https://doi.org/10.3390/diagnostics14192179 (registering DOI)
Submission received: 15 August 2024
/
Revised: 26 September 2024
/
Accepted: 29 September 2024
/
Published: 29 September 2024
Abstract
Background/Objectives:The Elecsys® 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® HCV Duo immunoassay effectively diagnosed HCV infection, regardless of HIV status, making it suitable for managing high-risk populations in resource-limited settings.
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MDPI and ACS Style
Ananchuensook, P.; Wongpiyabovorn, J.; Avihingsanon, A.; Tangkijvanich, P.
Performance of Elecsys® HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection. Diagnostics 2024, 14, 2179.
https://doi.org/10.3390/diagnostics14192179
AMA Style
Ananchuensook P, Wongpiyabovorn J, Avihingsanon A, Tangkijvanich P.
Performance of Elecsys® HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection. Diagnostics. 2024; 14(19):2179.
https://doi.org/10.3390/diagnostics14192179
Chicago/Turabian Style
Ananchuensook, Prooksa, Jongkonnee Wongpiyabovorn, Anchalee Avihingsanon, and Pisit Tangkijvanich.
2024. "Performance of Elecsys® HCV Duo Immunoassay for Diagnosis and Assessment of Treatment Response in HCV Patients with or without HIV Infection" Diagnostics 14, no. 19: 2179.
https://doi.org/10.3390/diagnostics14192179
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