1
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Chen B, Gao LY, Ma ZH, Chang H, Pei LJ, Zhou Q, Xing WG. The signal-to-cutoff ratios to predict HCV infection among people who inject drugs. Virusdisease 2022; 33:363-370. [PMID: 36278030 PMCID: PMC9579682 DOI: 10.1007/s13337-022-00797-5] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/21/2022] [Accepted: 10/03/2022] [Indexed: 11/22/2022] Open
Abstract
People who inject drugs (PWIDs) are primarily the high-risk population for HCV infection. This study aims to determine the optimal cut-off values for predicting HCV infection status based on the Signal-to-Cutoff (S/CO) ratio. In this study, a total of 719 PWIDs’ samples were collected, and performed for screening test by ELISA assay, and followed by RIBA assay and NAT assay to detect HCV antibody and HCV RNA levels, respectively. The findings revealed that the prevalence of HCV infection among PWIDs was 54.66% (393/719), and the false-positive rate of HCV antibody detection by ELISA assay among PWIDs was only 3.85% (16/416). In addition, when the optimal cut-off value for S/CO ratio was 2.0, the sensitivity and specificity of HCV antibody were 100.00% and 93.55%, respectively. And when the optimal cut-off value for S/CO ratio was 21.36, the sensitivity and specificity of HCV RNA positive were 89.90% and 72.73%, respectively. In conclusion, the status of HCV infection can be predicted based on the S/CO ratios of the ELISA assay, which can improve diagnosis and facilitate timely treatment to effectively prevent the spread of HCV infection.
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2
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Lee HW, Lee H, Kim BK, Chang Y, Jang JY, Kim DY. Cost-effectiveness of chronic hepatitis C screening and treatment. Clin Mol Hepatol 2021; 28:164-173. [PMID: 34955002 PMCID: PMC9013616 DOI: 10.3350/cmh.2021.0193] [Citation(s) in RCA: 15] [Impact Index Per Article: 3.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/05/2021] [Accepted: 12/24/2021] [Indexed: 11/09/2022] Open
Abstract
Hepatitis C virus (HCV) infection is the second most common cause of chronic liver disease in South Korea, with a prevalence ranging from 0.6% to 0.8%, and HCV infection incidence increases with age. The anti-HCV antibody test, which is cheaper than the HCV RNA assay, is widely used to screen for HCV infections; however, the underdiagnosis of HCV is a major barrier to the elimination of HCV infections. Although several risk factors have been associated with HCV infections, including intravenous drug use, blood transfusions, and hemodialysis, most patients with HCV infections present with no identifiable risk factors. Universal screening for HCV in adults has been suggested to improve the detection of HCV infections. We reviewed the cost-effectiveness of HCV screening and the methodologies used to perform screening. Recent studies have suggested that universal HCV screening and treatment using direct-acting antivirals represent cost-effective approaches to the prevention and treatment of HCV infection. However, the optimal timing and frequency of HCV screening remain unclear, and further studies are necessary to determine the best approaches for the elimination of HCV infections.
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Affiliation(s)
- Hye Won Lee
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.,Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.,Yonsei Liver Center, Severance Hospital, Seoul, Korea
| | - Hankil Lee
- College of Pharmacy, Ajou University, Suwon, Gyeonggi-do, Korea
| | - Beom Kyung Kim
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.,Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.,Yonsei Liver Center, Severance Hospital, Seoul, Korea
| | - Young Chang
- Department of Internal Medicine, Digestive Disease Center, Institute for Digestive Research, Soonchunhyang University College of Medicine, Seoul, Korea
| | - Jae Young Jang
- Department of Internal Medicine, Digestive Disease Center, Institute for Digestive Research, Soonchunhyang University College of Medicine, Seoul, Korea
| | - Do Young Kim
- Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.,Institute of Gastroenterology, Yonsei University College of Medicine, Seoul, Korea.,Yonsei Liver Center, Severance Hospital, Seoul, Korea
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3
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Atalay MA, Sağıroğlu P, Oskay M, Emir B. Comparison of samples found positive by anti-HCV screening test with line immunoassay and determination of threshold value. Rev Assoc Med Bras (1992) 2021; 67:1480-1484. [DOI: 10.1590/1806-9282.20210668] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/16/2021] [Accepted: 08/17/2021] [Indexed: 11/22/2022] Open
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4
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Castaneda D, Gonzalez AJ, Alomari M, Tandon K, Zervos XB. From hepatitis A to E: A critical review of viral hepatitis. World J Gastroenterol 2021; 27:1691-1715. [PMID: 33967551 PMCID: PMC8072198 DOI: 10.3748/wjg.v27.i16.1691] [Citation(s) in RCA: 71] [Impact Index Per Article: 17.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2021] [Revised: 03/02/2021] [Accepted: 04/09/2021] [Indexed: 02/06/2023] Open
Abstract
Viral infections affecting the liver have had an important impact on humanity, as they have led to significant morbidity and mortality in patients with acute and chronic infections. Once an unknown etiology, the discovery of the viral agents triggered interest of the scientific community to establish the pathogenesis and diagnostic modalities to identify the affected population. With the rapid scientific and technological advances in the last centuries, controlling and even curing the infections became a possibility, with a large focus on preventive medicine through vaccination. Hence, a comprehensive understanding of hepatitis A, B, C, D and E is required by primary care physicians and gastroenterologists to provide care to these patients. The review article describes the epidemiology, pathogenesis, clinical presentation, diagnostic tools and current medication regimens, with a focus on upcoming treatment options and the role of liver transplantation.
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Affiliation(s)
- Daniel Castaneda
- Digestive Disease Institute, Cleveland Clinic Florida, Weston, FL 33331, United States
| | | | - Mohammad Alomari
- Digestive Disease Institute, Cleveland Clinic Florida, Weston, FL 33331, United States
| | - Kanwarpreet Tandon
- Digestive Disease Institute, Cleveland Clinic Florida, Weston, FL 33331, United States
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5
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Neves WLL, Mariuba LAM, Alves KCS, Coelho KF, Tarragô AM, Costa AG, Chaves YO, Victoria FDS, Victoria MB, Malheiro A. Development of an immunoassay for the detection of human IgG against hepatitis C virus proteins using magnetic beads and flow cytometry. BIOTECHNOL BIOTEC EQ 2020. [DOI: 10.1080/13102818.2020.1839355] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/12/2022] Open
Affiliation(s)
- Walter Luiz Lima Neves
- Post-graduate Program in Basic and Applied Immunology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Post-graduate Program in Biotechnology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
| | - Luis André Morais Mariuba
- Post-graduate Program in Basic and Applied Immunology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Post-graduate Program in Biotechnology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Leonidas & Maria Deane Research Institute, FIOCRUZ-Amazônia, Manaus, AM, Brazil
- Postgraduate Program Stricto sensu in Cellular and Molecular Biology of the Oswaldo Cruz Institute (PGBCM/IOC/Fiocruz), Rio de Janeiro, Brazil
| | - Késsia Caroline Souza Alves
- Post-graduate Program in Biotechnology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
| | - Kerolaine Fonseca Coelho
- Department of Education and Research, Amazonas Hospital Foundation of Hematology and Hemotherapy (HEMOAM), Manaus, AM, Brazil
- Post-graduate Program in Tropical Medicine, State University of Amazonas (UEA), Manaus, AM, Brazil
| | - Andrea Monteiro Tarragô
- Post-graduate Program in Basic and Applied Immunology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Department of Education and Research, Amazonas Hospital Foundation of Hematology and Hemotherapy (HEMOAM), Manaus, AM, Brazil
- Post-graduate Program in Tropical Medicine, State University of Amazonas (UEA), Manaus, AM, Brazil
| | - Allyson Guimarães Costa
- Post-graduate Program in Basic and Applied Immunology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Department of Education and Research, Amazonas Hospital Foundation of Hematology and Hemotherapy (HEMOAM), Manaus, AM, Brazil
- Post-graduate Program in Tropical Medicine, State University of Amazonas (UEA), Manaus, AM, Brazil
- Post-graduate Program in Hematology Sciences, State University of Amazonas (UEA), Manaus, AM, Brazil
- Carlos Borborema Clinical Research Institute, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD), Manaus, AM, Brazil
| | - Yury Oliveira Chaves
- Post-graduate Program in Hematology Sciences, State University of Amazonas (UEA), Manaus, AM, Brazil
| | - Flamir da Silva Victoria
- Post-graduate Program in Hematology Sciences, State University of Amazonas (UEA), Manaus, AM, Brazil
- Carlos Borborema Clinical Research Institute, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD), Manaus, AM, Brazil
| | - Marilu Barbieri Victoria
- Post-graduate Program in Hematology Sciences, State University of Amazonas (UEA), Manaus, AM, Brazil
- Carlos Borborema Clinical Research Institute, Fundação de Medicina Tropical Doutor Heitor Vieira Dourado (FMT-HVD), Manaus, AM, Brazil
| | - Adriana Malheiro
- Post-graduate Program in Basic and Applied Immunology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Post-graduate Program in Biotechnology, Institute of Biological Sciences, Federal University of Amazonas (UFAM), Manaus, AM, Brazil
- Post-graduate Program in Tropical Medicine, State University of Amazonas (UEA), Manaus, AM, Brazil
- Post-graduate Program in Hematology Sciences, State University of Amazonas (UEA), Manaus, AM, Brazil
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6
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New Diagnostic Approaches to Viral Sexually Transmitted Infections. Sex Transm Infect 2020. [DOI: 10.1007/978-3-030-02200-6_6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/27/2022] Open
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7
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Soliman G, Elzalabany MS, Hassanein T, Miller FD. Mass screening for hepatitis B and C in Southern Upper Egypt. BMC Public Health 2019; 19:1326. [PMID: 31640639 PMCID: PMC6805514 DOI: 10.1186/s12889-019-7640-1] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2019] [Accepted: 09/16/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND It is well documented that Egypt has the highest prevalence of hepatitis C virus (HCV) infection in the world. The recent development of highly effective direct acting antiviral drugs (DAAs), has opened the possibility of treating and curing HCV infection in the Egyptian population on a large scale. METHODS A screening demonstration project was implemented in southern Egypt in and around the city of Luxor. Free screening and if indicated, treatment, was offered to those 16 years or older for anti-HCV antibodies (anti-HCV) and hepatitis B surface antigen (HBsAg) using third generation enzyme immunoassays (Enzygnost® Anti-HCV and HbsAg). Statistical methods included estimation of odds ratios (OR) and 95% confidence intervals (95% CI). RESULTS There was a large turnout of 67,042 persons who were screened in a 12-month period starting in June 2016. Thirty-one thousand nine hundred sixty-four males (47.7%) and 35,074 females (52.3%) were screened with a mean age of 43.6 ± 14.3 years. Nine thousand seven hundred one patients (14.5%) were positive for anti-HCV and 2950 (4.4%) for HBsAg. Prevalence of anti-HCV was significantly higher in males than females (19.67% vs.9.73% OR = 2.27; CI 2.2 to 2.4; p < 0.001) and the same for HBsAg (6.2% vs. 2.8% OR = 2.3; CI 2.2 to 2.5; p < 0.001). The prevalence of anti-HCV was significantly associated with age (p < 0.001), ranging from between 1 and 4% in individuals below the age of 40 years, then increased steadily to 42% at age 60 followed by a precipitous decline in age specific prevalence. CONCLUSIONS The results showed unanticipated patterns in the Luxor area of anti-HCV and HBsAg by age and gender in contrast to previous reports on this unique HCV epidemic in Egypt. Moreover, the level and rate of turnout, cost, and other logistical issues, provided essential information for effective planning, design, and evaluation methods for larger national mass screening and treatment programs.
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Affiliation(s)
- Gamal Soliman
- Tropical Medicine, Gastroenterology and Hepatology Department, Faculty of Medicine, Al-Azhar University, Cairo, Egypt
| | | | | | - F. DeWolfe Miller
- John A. Burns School of Medicine, University of Hawaii, Honolulu, HI USA
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8
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Mazzarella C, Rocco C, Vallefuoco L, Sorrentino R, Braschi U, Lauritano G, Di Biase A, Misso S, Portella G. Differential reactivity of anti-hepatitis C virus screening assays in patients with waning antibodies. Future Virol 2019. [DOI: 10.2217/fvl-2018-0195] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022]
Abstract
Hepatitis C virus (HCV) leads to persistent infection. Viral clearance can be obtained through pharmacological treatment or spontaneously. After viral clearance, anti-HCV antibodies (Abs) slowly decline and finally disappear. Subjects with a resolved HCV infection are reactive to anti-HCV screening assays for a long time. These subjects pose a diagnostic challenge, and therefore, a more accurate interpretation of laboratory tests is needed for cases with resolved HCV infection. However, the performances of anti-HCV screening assays against declining anti-HCV Abs have not been assessed. Here we evaluated 1509 samples with different screening assays. Screening assays provided discrepant results in patients with waning Abs. The identification of signal-to-cut-off values indicative of waning Abs for each anti-HCV assay could avoid unnecessary confirmatory tests and reduce the impact of misdiagnosis.
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Affiliation(s)
- Claudia Mazzarella
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Caterina Rocco
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Luca Vallefuoco
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Rosanna Sorrentino
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Umberto Braschi
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Gaetano Lauritano
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
| | - Antonio Di Biase
- UOC Immunoematologia e Medicina Trasfusionale ASL Caserta Ospedale Moscati, viale A Gramsci Aversa, Caserta, Italy
| | - Saverio Misso
- UOC Immunoematologia e Medicina Trasfusionale ASL Caserta Ospedale Moscati, viale A Gramsci Aversa, Caserta, Italy
| | - Giuseppe Portella
- Dipartimento di Scienze Mediche Traslazionali, Università Federico II – UOSD Virologia DAI Medicina Interna e Patologia Clinica, AOU Federico II, via S Pansini 5 -80131 Napoli, Italy
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9
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Sette LHBC, Lopes EPDA, Guedes dos Anjos NC, Valente LM, Vieira de Oliveira SA, Lucena-Silva N. High prevalence of occult hepatitis C infection in predialysis patients. World J Hepatol 2019; 11:109-118. [PMID: 30705723 PMCID: PMC6354127 DOI: 10.4254/wjh.v11.i1.109] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/28/2018] [Revised: 12/20/2018] [Accepted: 01/04/2019] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND Occult hepatitis C virus (HCV) infection (OCI) may be associated with extrahepatic diseases and it is known that the patients with chronic kidney disease (CKD) who are on hemodialysis (HD) present a higher prevalence of this type of infection than the general population, with a worse clinical outcome. However, there are no data in the literature to assess the presence of OCI in patients prior to the initiation of renal replacement therapy (RRT). Therefore, this study aimed to evaluate the occurrence and epidemiological aspects of OCI in patients with Predialysis CKD. We hypothesize that this infection could occur before RRT initiation.
AIM To research the status in predialysis patients when HD patients have high prevalence of OCI.
METHODS A cross-sectional study was conducted between 2015 and 2017. Adults with creatinine clearance < 60 mL/min·1.73 m2 (predialysis patients) were recruited to the study. Pregnant and postpartum women, patients with glomerulopathies, and patients showing positivity for serological markers of hepatitis B virus (HBV), HCV or human immunodeficiency virus infection were excluded. Patients were diagnosed with OCI according to test results of anti-HCV antibody negativity and HCV RNA positivity in either ultracentrifuged serum or, if serum-negative, in peripheral blood mononuclear cells.
RESULTS Among the 91 total patients included in the study, the prevalence of OCI was 16.5%. Among these 15 total OCI patients, 1 was diagnosed by 14 ultracentrifuged serum results and 14 were diagnosed by peripheral blood mononuclear cell results. Compared to the non-OCI group, the OCI patients presented higher frequency of older age (P = 0.002), patients with CKD of mixed etiology (P = 0.019), and patients with markers of previous HBV infection (i.e., combined positivity for anti-hepatitis B core protein antibody and anti-hepatitis B surface protein antibody) (P = 0.001).
CONCLUSION Among predialysis patients, OCI involved the elderly, patients with CKD of mixed etiology, and patients with previous HBV infection.
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Affiliation(s)
| | | | | | - Lucila Maria Valente
- Nephrology-Department of Clinical Medicine, Federal University of Pernambuco, Pernambuco 50670-901, Brazil
| | | | - Norma Lucena-Silva
- Laboratory of Immunogenetics of the Aggeu Magalhães Institute - Fiocruz Pernambuco, Pernambuco 50670-420, Brazil
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10
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Gauna A, Losada S, Lorenzo M, Toledo M, Bermúdez H, D'Angelo P, Sánchez D, Noya O. Use of Synthetic Peptides and Multiple Antigen Blot Assay in the Immunodiagnosis of Hepatitis C Virus Infection. Viral Immunol 2018; 31:568-574. [PMID: 30256730 DOI: 10.1089/vim.2018.0023] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
Acute hepatitis C virus (HCV) infection is usually asymptomatic, therefore, early diagnosis is rare. It may remain undiagnosed in individuals who progress to chronic infection, often until serious liver damage has developed. To incorporate the diagnosis of this viral disease in a multiple-diagnostic assay, we first analyzed by immunoinformatics the HCV subtype 1a polyprotein (specifically Core, E2, NS3, NS5A proteins) to select antigenic peptides to be tested initially by the Pepscan technique. Next, we performed the immunodiagnosis of HCV infection, using the Multiple Antigen Blot Assay (MABA). In 22 patients' sera included in this study, a 20-mer linear peptide belonging to the N-terminus of the worldwide conserved Core protein showed 100% sensitivity and specificity; other sequences showed different levels of antibody recognition. The use of MABA in combination with synthetic peptides as a source of multiple, specific, and nonexpensive antigens for other infectious diseases could represent a rapid, integrated, and inexpensive diagnostic methodology.
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Affiliation(s)
- Adriana Gauna
- 1 Programa de Doctorado en Biotecnología, Pontificia Universidad Católica de Valparaíso/Universidad Técnica Federico Santa María , Valparaíso, Chile
| | - Sandra Losada
- 2 Sección de Biohelmintiasis, Instituto de Medicina Tropical , Facultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela
| | - María Lorenzo
- 2 Sección de Biohelmintiasis, Instituto de Medicina Tropical , Facultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela
| | - Marilyan Toledo
- 3 Cátedra de Parasitología, Escuela de Medicina "Luis Razetti," Universidad Central de Venezuela , Caracas, Venezuela
| | - Henry Bermúdez
- 2 Sección de Biohelmintiasis, Instituto de Medicina Tropical , Facultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela
| | - Pierina D'Angelo
- 4 Laboratorio de Programas Especiales-Hepatitis y SIDA, Dpto de Virología, Gerencia Sectorial de Diagnóstico y Vigilancia Epidemiológica, Instituto Nacional de Higiene "Rafael Rangel ," Caracas, Venezuela
| | - Doneyla Sánchez
- 4 Laboratorio de Programas Especiales-Hepatitis y SIDA, Dpto de Virología, Gerencia Sectorial de Diagnóstico y Vigilancia Epidemiológica, Instituto Nacional de Higiene "Rafael Rangel ," Caracas, Venezuela
| | - Oscar Noya
- 2 Sección de Biohelmintiasis, Instituto de Medicina Tropical , Facultad de Medicina, Universidad Central de Venezuela, Caracas, Venezuela .,5 Centro para Estudios Sobre Malaria, Instituto de Altos Estudios "Dr. Arnoldo Gabaldón" Instituto Nacional de Higiene-Ministerio del Poder Popular para la Salud , Caracas, Venezuela
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11
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Naz A, Mukry SN, Naseer I, Shamsi TS. Evaluation of efficacy of serological methods for detection of HCV infection in blood donors: A single centre experience. Pak J Med Sci 2018; 34:1204-1208. [PMID: 30344577 PMCID: PMC6191814 DOI: 10.12669/pjms.345.15707] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/20/2022] Open
Abstract
Background and Objective: Blood transfusion is an essential and life-saving medical intervention. Despite multiple preventive measures transfusion-transmitted hepatitis C virus (HCV) infection continues to be a major healthcare issue in Pakistan. This study was conducted at National Institute of Blood Diseases & Bone Marrow Transplantation to evaluate the frequency of active HCV infection with or without co-infection in blood donors and also to determine comparative efficacy of Multisure HCV antibody assay (MHAA); a new serological device. Methods: A total of 14652 blood donors visiting National Institute of Blood Diseases & Bone Marrow Transplantation (NIBD) Blood Bank from January 2013 to July 2014 were enrolled and screened for a range of blood borne infections such as HBV, HCV, HIV, malaria and syphilis. The HCV was screened simultaneously by Abbot Architect anti-HCV assay (CLIA) and MHAA. The active HCV infection was confirmed by nucleic acid testing (NAT) in reactive donors. Later; for determination of comparative efficacy of MHAA; all NAT positive samples were further tested using Monolisa™, HCV blot 3.0, Anti-HCV plus V2 and Anti-HCV-MPBIO-EIA. Results: The HCV reactive sera were observed in 1.563% (226) donors. The NAT confirmed active HCV infection in 138 donors. Overall 27.84% of HCV positive donors exhibited co-infection either with HBV (2.57%), syphilis (22.78%). Triple infection was not observed in any donor. The efficacy of MHAA is comparable to all the serological tests with a sensitivity of about 96.89%. Conclusion: Active HCV infection was present in 0.94% donors. With a sensitivity of 96.89% (95% CI: 95.66-98.12) the multi-parametric device MHAA can effectively detect HCV infection in donors. Thus, it can be used in limited health care settings for HCV screening.
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Affiliation(s)
- Arshi Naz
- Arshi Naz, PhD. National Institute of Blood Diseases & Bone Marrow Transplantation, Karachi, Pakistan
| | - Samina Naz Mukry
- Samina Naz Mukry, PhD. National Institute of Blood Diseases & Bone Marrow Transplantation, Karachi, Pakistan
| | - Imran Naseer
- Imran Naseer, B.Sc. National Institute of Blood Diseases & Bone Marrow Transplantation, Karachi, Pakistan
| | - Tahir Sultan Shamsi
- Tahir Sultan Shamsi, FRC Path. National Institute of Blood Diseases & Bone Marrow Transplantation, Karachi, Pakistan
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12
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Yang X, Ye Y, Wang T, Li M, Yu L, Xia M, Qian J, Hu Z. Eu 3+ /Sm 3+ dual-label time-resolved fluoroimmunoassay for measurement of hepatitis C virus antibodies. J Clin Lab Anal 2018; 33:e22659. [PMID: 30152027 DOI: 10.1002/jcla.22659] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2018] [Revised: 07/23/2018] [Accepted: 08/03/2018] [Indexed: 01/23/2023] Open
Abstract
AIM To develop a new immunoassay based on the time-resolved fluorescence immunoassay (TRFIA) system for the simultaneous measurement of IgM and IgG antibodies to HCV. METHODS Coated recombinant HCV antigens and Eu3+ -labeled IgM and Sm3+ -labeled IgG antibodies were prepared. HCV-IgM/IgG TRFIA was established and optimized, followed by a methodological assessment. Data were expressed as x ¯ +SD and analyzed using the SPSS 13.0 software. The percentile method was used to calculate cutoff values. RESULTS The detection sensitivities of HCV-IgM and HCV-IgG were 0.06 S/CO and 0.15 S/CO, respectively. There was a good linear response from 1:40 to 1:40 960 for HCV-IgM and 1:20 to 1:40 960 for HCV-IgG, when samples strongly positive for HCV-IgM and HCV-IgG were serially diluted from 1:10 to 1:81 920. The average intra-assay coefficients of variation (CV) for HCV-IgM and -IgG were 3.45% and 3.71% and the inter-assay coefficients of variation (CV) were 6.49% and 6.79%, respectively. When HCV-negative/positive sera were tested by ELISA and using established kits, the negative, positive, and total conformity rates for HCV-IgM were 93.3% (28/30), 100% (25/25), and 96.4% (53/55), and those for HCV-IgG were 93.3% (28/30), 100% (35/35), and 96.9% (63/65), respectively. Additionally, the established kit exhibited good stability, with declines in fluorescence values to 11.1% and 9.5%, respectively, after storage at 37°C for 7 days. CONCLUSION We established a dual-label HCV-IgM/IgG TRFIA assay with a wide detection range, high specificity, high sensitivity, good stability, and good clinical value for the simultaneous measurement of HCV-IgM and HCV-IgG titers in a single test.
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Affiliation(s)
- Xue Yang
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Yan Ye
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Tingting Wang
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Mei Li
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Lei Yu
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Min Xia
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Jun Qian
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
| | - Zhigang Hu
- Affiliated Wuxi People's Hospital of Nanjing Medical University, Wuxi Children's Hospital, Wuxi, Jiangsu, China
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13
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Yue ZH, Xia CS, Wang H. Performance evaluation of the mindray anti-HCV assay for the detection of hepatitis C virus infection. J Clin Lab Anal 2018; 32:e22600. [PMID: 30058207 DOI: 10.1002/jcla.22600] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2018] [Accepted: 06/05/2018] [Indexed: 11/06/2022] Open
Abstract
BACKGROUND Anti-hepatitis C virus (anti-HCV) antibody assays are recommended for HCV infection screening. The Mindray anti-HCV assay, based on a third-generation immunoassay, was recently launched in China. We aimed to evaluate its diagnostic performance compared with that of two other widely used assays. METHODS Six HCV infection seroconversion panels were used to evaluate the sensitivity of the assay for early detection. A total of 1952 clinical samples were tested by the Mindray anti-HCV, Elecsys anti-HCV II, and Architect anti-HCV assays. Samples with reactive results using at least one anti-HCV assay were further tested with the recombinant immunoblot assay (RIBA). Inconsistent results were investigated by the HCV RNA assay and HCV core antigen assay. HCV infection diagnosis was made according to the results of laboratory tests and medical records. RESULTS The Mindray anti-HCV assay and Elecsys anti-HCV II assay detected seroconversion in an average of 12.5 days and 10.5 days, respectively, and this difference was not significant (P = .818). Of the 1952 cases, 90 were categorized as "HCV infection" and 1862 were categorized as "no HCV infection." The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (LR+), and negative likelihood ratio (LR-) of each assay were as follows: the Mindray anti-HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and 0.045, respectively; the Architect anti-HCV assay, 98.9%, 95.2%, 50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respectively. There were significant differences in the specificity, PPV and LR+ among the three assays (P < .001). There were no significant differences in the sensitivity, NPV or LR- among the three assays (P > .05). CONCLUSIONS The Mindray anti-HCV assay displays a similar sensitivity to the Elecsys anti-HCV II assay with respect to the early detection of HCV infection. The Mindray anti-HCV assay shows excellent diagnostic performance and is suitable for the screening of HCV infection.
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Affiliation(s)
- Zhi-Hong Yue
- Department of Clinical Laboratory, Peking University People's Hospital, Beijing, China
| | - Chang-Sheng Xia
- Department of Clinical Laboratory, Peking University People's Hospital, Beijing, China
| | - Hui Wang
- Department of Clinical Laboratory, Peking University People's Hospital, Beijing, China
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Gaballah AM, Esawy MM. Comparison of 2 different antibody assay methods, Elecsys Anti-HCVII (Roche) and Vidas Anti-HCV (Biomerieux), for the detection of antibody to hepatitis C virus in Egypt. Diagn Microbiol Infect Dis 2018; 92:107-111. [PMID: 29925467 DOI: 10.1016/j.diagmicrobio.2018.05.013] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/17/2017] [Revised: 05/16/2018] [Accepted: 05/16/2018] [Indexed: 02/02/2023]
Abstract
The measurement of antibodies against hepatitis C virus (HCV) is important to screen HCV infection. The aim of this study is to investigate the reliability of 2 commercially available anti-HCV antibody kits used in routine laboratory testing in Egypt. One thousand nine hundred and thirty-one serum samples were analyzed using 2 anti-HCV test systems: Cobas e 411® Elecsys Anti-HCVII and Vidas® Anti-HCV Biomerieux. Discrepant samples were tested using the recombinant immunoblot assay Innogenetics® INNO-LIA HCV Score. Overall agreement of the 2 tests was 94%. Following discrepant sample testing by LIA, sensitivity and specificity using Vidas were 94% and 99%, respectively, while those for Cobas were 97% and 96%, respectively. This study demonstrates superior specificity by Vidas and higher sensitivity by Cobas. Both methods are suitable for laboratory and/or blood screening programs. The concomitant use of a supplementary or confirmatory assay is necessary to compare the accuracy of HCV serological assays.
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Affiliation(s)
| | - Marwa Mohammed Esawy
- Department of Clinical Pathology, Faculty of Medicine, Zagazig University, Egypt.
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15
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Pondé RADA. The serological markers of acute infection with hepatitis A, B, C, D, E and G viruses revisited. Arch Virol 2017; 162:3587-3602. [PMID: 28884240 DOI: 10.1007/s00705-017-3538-3] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2016] [Accepted: 12/20/2016] [Indexed: 12/19/2022]
Abstract
Viral hepatitis is a liver infection caused by one of the six hepatitis viruses: hepatitis A, B, C, D, E, and G virus (HAV to HEV and HGV). These agents differ in their biological, immunological, pathological and epidemiological characteristics. They cause infections that, when symptomatic, lead to clinical manifestations and laboratory findings that are not specific to a particular virus, often making differential diagnosis difficult, especially when no knowledge is available regarding the patient's medical history or the epidemiological background. A number of acute-phase serological markers, such as anti-HAV, anti-HBc, anti-HDV and anti-HEV IgM antibodies, are able to provide a clear indication of an infection caused by HAV, HBV, HDV or HEV. Anti-HCV antibodies and HGV/RNA are used for the diagnosis of HCV and HGV infections. The importance of each of these markers will be reviewed, and different factors that can interfere with the diagnosis of acute infections caused by these viruses will be described.
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Affiliation(s)
- Robério Amorim de Almeida Pondé
- Laboratory of Human Virology, Institute of Tropical Pathology and Public Health, Federal University of Goias, Goiânia, Goiás, Brazil. .,Secretaria Estadual de Saúde -SES/Superintendência de Vigilância em Saúde-SUVISA/GO, Gerência de Vigilância em Saúde-GVE/Coordenação de Análises e Pesquisas-CAP, Goiânia, Goiás, Brazil. .,Faculdade União de Goyazes-FUG (College Union of Goyazes), Department of Hematology and Clinical Microbiology, Trindade, Goiás, Brazil. .,, Rua 136 Qd F44 Lt 22/24 Ed. César Sebba - Setor Sul, Goiânia, Goiás, 74-093-250, Brazil.
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16
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Fletcher GJ, Raghavendran A, Sivakumar J, Samuel P, Abraham P. Diagnostic reliability of Architect anti-HCV assay: Experience of a tertiary care hospital in India. J Clin Lab Anal 2017; 32. [PMID: 28657153 DOI: 10.1002/jcla.22245] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/03/2017] [Accepted: 03/28/2017] [Indexed: 01/02/2023] Open
Abstract
BACKGROUND & AIMS Anti-HCV assays are prone to false positive results. Thus, accurate detection of HCV infection is critical for the timely therapeutic management. This study ascertained the reliability of Architect anti-HCV assay (Abbott) and to estimate the agreement of this assay with Ortho HCV 3.0 ELISA Test System with Enhanced SAVe (Ortho), HCV Tri-dot (Tri-dot) and HCV-PCR in a tertiary care setting. METHODS A total of 78 788 consecutive sera were routinely screened for anti-HCV antibodies using Architect. All repeatedly reactive anti-HCV sera (n=1000) and anti-HCV negative sera (n=300) were tested in Ortho and in Tri-dot assays. Representative proportions of sera (n=500) with various signal-to-cut-off (S/Co) ratio were also compared with HCV-PCR. RESULTS When Architect was compared with Ortho, Tri-dot, and HCV-PCR, the level of agreement as assessed by kappa were .26, .16, and .27 respectively. Using Latent class analysis (LCA), we found that sensitivity and specificity were 100% and 36.1% for Architect, 93.8% and 100% for Ortho and 63.8% and 100% for Tri-dot respectively. The median S/CO ratio of Architect and Ortho anti-HCV assays were significantly different between HCV-PCR positive and negative results (P<.0001). Furthermore, Architect S/CO ratio of >8 showed higher accuracy indices in both anti-HCV assays. CONCLUSIONS Architect can be used as a screening assay because of its high sensitivity, high throughput, and short turnaround time. However, S/Co ratios of ≥1 to <8 in Architect necessitates HCV PCR to identify current infection and or EIA to distinguish true positivity from false biological positivity.
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Affiliation(s)
| | | | | | - Prasanna Samuel
- Department of Bio-statistics, Christian Medical College, Vellore, India
| | - Priya Abraham
- Department of Clinical Virology, Christian Medical College, Vellore, India
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17
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Kim B, Ahn HJ, Choi MH, Park Y. Retrospective analysis on the diagnostic performances and signal-to-cut-off ratios of the Elecsys Anti-HCV II assay. J Clin Lab Anal 2017; 32. [PMID: 28187227 DOI: 10.1002/jcla.22165] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/22/2016] [Accepted: 01/14/2017] [Indexed: 01/19/2023] Open
Abstract
BACKGROUND Anti-HCV assays are widely used as a screening tool for HCV infection. However, diagnostic performances and effective signal-to-cut-off ratios (S/COs) for predicting true HCV infections would vary according to the assays used. Thus, we evaluated the diagnostic performances of the new Elecsys Anti-HCV assay. METHODS A total of 41 694 cases tested by the Elecsys Anti-HCV II assay (Roche Diagnostics, Germany) during January 2013 to December 2015 were retrospectively analyzed by comparing with the diagnosis on HCV infections determined by patients' medical records and results of laboratory tests. RESULTS Excluding 62 cases with unclear history of HCV infection, 430 and 41 202 cases were respectively assorted as "true infection" and "no evidence of infection," and 99.85% of the initial results by the Elecsys assay were concordant with the diagnosis on HCV infection. Sensitivity, specificity, positive and negative predictive values were respectively 99.30%, 99.86%, 88.04%, and 99.99%, where the prevalence of the HCV infection was 1.0%. The area under the receiver operating characteristics curve value of the Elecsys assay was 0.9980 (95% confidence interval [CI]=0.9944 to 1.0017). The S/CO by the Elecsys assay for predictive of a true-positive ≥95% of the time was 19.0 (95% CI=15.0 to 25.1). CONCLUSION The Elecsys Anti-HCV II assay showed excellent diagnostic performances, particularly in terms of sensitivity, specificity, and NPV. However, the results obtained by this assay with S/CO less than a certain value would need to be retested by HCV RNA PCR or another anti-HCV assay.
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Affiliation(s)
- Banseok Kim
- Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea
| | - Hyo Jun Ahn
- Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea
| | - Min Hyuk Choi
- Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea.,Department of Laboratory Medicine, Yonsei University College of Medicine, Seoul, Korea
| | - Yongjung Park
- Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital, Goyang, Korea
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Hyun J, Ko DH, Kang HJ, Whang DH, Cha YJ, Kim HS. Evaluation of the VIDAS Anti-HCV Assay for Detection of Hepatitis C Virus Infection. Ann Lab Med 2017; 36:550-4. [PMID: 27578508 PMCID: PMC5011108 DOI: 10.3343/alm.2016.36.6.550] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/16/2016] [Revised: 05/22/2016] [Accepted: 07/19/2016] [Indexed: 01/17/2023] Open
Abstract
BACKGROUND Anti-hepatitis C virus antibody (anti-HCV) assays are recommended for screening HCV-infected persons. The VIDAS Anti-HCV Assay (bioMérieux, France), based on the enzyme-linked fluorescence test principle, was recently introduced in Korea. We evaluated the clinical performance of the VIDAS assay. METHODS One hundred HCV-positive and 1,002 HCV-negative blood samples confirmed by Architect anti-HCV (Abbott Laboratories, USA) and COBAS TaqMan HCV real-time PCR (Roche Diagnostics, USA) or the Procleix Ultrio Plus Assay (Gen-Probe Incorporated, USA) were obtained from the Human Serum Bank (HSB) and tested by VIDAS. In case of discrepant results, we conducted a recombinant immunoblot assay (RIBA). RESULTS The agreement rates for known HCV-positive and HCV-negative samples between the VIDAS assay and the HSB testing were 100% (95% confidence interval [CI]: 96.4-100%) and 99.5% (95% CI: 98.8-99.8%), respectively. One of the five discrepant samples was positive for Core 2+ and NS3-2 2+ reactivity, two samples were negative, and the other two were indeterminate regarding NS4 2+ reactivity in RIBA. We observed a significant but weak positive correlation between the titers of VIDAS and Architect assays (r=0.315, P<0.001). CONCLUSIONS The VIDAS anti-HCV assay, developed on the VIDAS automated immunoassay platform based on the ready-to-use, single-sample test concept may be useful in small-to-medium-sized laboratories. It showed good agreement with Architect anti-HCV and COBAS PCR assays and is therefore useful for detection of HCV infection. Weakly test-positive (ambiguous) samples require additional testing by another anti-HCV, RIBA, or HCV RNA assay.
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Affiliation(s)
- Jungwon Hyun
- Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea
| | - Dae Hyun Ko
- Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea
| | - Hee Jung Kang
- Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea
| | - Dong Hee Whang
- Department of Laboratory Medicine, Inje University College of Medicine, Seoul, Korea
| | - Young Joo Cha
- Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
| | - Hyun Soo Kim
- Department of Laboratory Medicine, Hallym University College of Medicine, Hwaseong, Korea.
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19
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Hepatitis C virus infection in maintenance hemodialysis patients: recommendations for diagnostics and treatment. Int J Artif Organs 2017; 39:590-595. [PMID: 28165585 DOI: 10.5301/ijao.5000548] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/31/2016] [Indexed: 12/19/2022]
Abstract
Hepatitis C virus (HCV) infection is highly prevalent among patients treated with maintenance hemodialysis and is an important cause of morbidity and mortality. It is necessary to determine the HCV genotype and the viral load to monitor the clinical and laboratory features and to establish an optimal antiviral treatment strategy. Antiviral treatments are presented with a standard interferon-based regimen and new direct-acting antiviral agents. The advent of direct-acting antivirals has improved the efficacy and safety of HCV treatment for most patients, even in difficult-to-treat populations such as patients on hemodialysis. HCV treatment with direct-acting antivirals in hemodialysis patients is highly effective, with viral eradication rates similar to those seen in patients without chronic kidney disease and with acceptable adverse event profiles.
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State of the Art, Unresolved Issues, and Future Research Directions in the Fight against Hepatitis C Virus: Perspectives for Screening, Diagnostics of Resistances, and Immunization. J Immunol Res 2016; 2016:1412840. [PMID: 27843956 PMCID: PMC5098088 DOI: 10.1155/2016/1412840] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/30/2016] [Revised: 09/09/2016] [Accepted: 09/20/2016] [Indexed: 12/13/2022] Open
Abstract
Hepatitis C virus (HCV) still represents a major public health threat, with a dramatic burden from both epidemiological and clinical points of view. New generation of direct-acting antiviral agents (DAAs) has been recently introduced in clinical practice promising to cure HCV and to overcome the issues related to the interferon-based therapies. However, the emergence of drug resistance and the suboptimal activity of DAAs therapies against diverse HCV genotypes have been observed, determining treatment failure and hampering an effective control of HCV spread worldwide. Moreover, these treatments remain poorly accessible, particularly in low-income countries. Finally, effective screening strategy is crucial to early identifying and treating all HCV chronically infected patients. For all these reasons, even though new drugs may contribute to impacting HCV spread worldwide a preventive HCV vaccine remains a cornerstone in the road to significantly reduce the HCV spread globally, with the ultimate goal of its eradication. Advances in molecular vaccinology, together with a strong financial, political, and societal support, will enable reaching this fundamental success in the coming years. In this comprehensive review, the state of the art about these major topics in the fight against HCV and the future of research in these fields are discussed.
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Evaluation of the Novel HISCL Chemiluminescence Enzyme Immunoassay for Laboratory Screening of Hepatitis C Virus. CLINICAL AND VACCINE IMMUNOLOGY : CVI 2016; 23:652-4. [PMID: 27170643 DOI: 10.1128/cvi.00078-16] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Subscribe] [Scholar Register] [Received: 04/06/2016] [Accepted: 05/06/2016] [Indexed: 02/05/2023]
Abstract
The hepatitis C virus (HCV) antibody assay remains the first-line screening test to identify HCV infection. The newly arrived HISCL Anti-HCV assay had a satisfactory seroconversion sensitivity. Its sensitivity and specificity were 98.97 and 100% for clinical samples. In general, the HISCL Anti-HCV assay may be a novel choice for clinical HCV screening.
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22
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Seignères B, Descamps F, Croise R, Barlet V, Bouvier-Alias M, Chevaliez S, Pawlotsky JM, Abdelhady W, Rafik M, Avellon AM, Echevarria JM, Hausmann M, Dugua JM. Multicenter clinical evaluation of the new 3rd generation assay for detection of antibodies against hepatitis C virus on the VIDAS(®) system. J Clin Virol 2016; 78:20-6. [PMID: 26962723 DOI: 10.1016/j.jcv.2016.03.001] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/21/2015] [Revised: 02/19/2016] [Accepted: 03/01/2016] [Indexed: 01/21/2023]
Abstract
BACKGROUND Detection of antibodies (anti-HCV) against hepatitis C virus (HCV) is indispensable for screening and diagnosis of viral hepatitis and for the viral safety of blood, tissue or organ donations. It gains additional importance by the new HCV drugs which improve the therapeutic possibilities dramatically. OBJECTIVE To evaluate the performance of a newly developed immune assay for anti-HCV based on the well-established VIDAS platform. STUDY DESIGN The assay was evaluated with samples from anti-HCV negative blood donors and from patients with or without HCV markers in six centres in France, Spain and Egypt. The status of the samples was determined by using CE-marked immune assays (Architect, AxSym, Prism, Vitros), two immunoblots (RIBA, Inno-Lia) and/or HCV RNA results. RESULTS Specificity was 99.67% in 10,320 French blood donors without anti-HCV, 99.5% in 200 anti-HCV negative hospitalized European patients and 99.0% in 198 negative patients from Egypt. Sensitivity was 99.7% in 1054 patients pretested positive by other assays; 345 patients with known genotype had genotype 1-6; 61 patients were co-infected with HIV. VIDAS was reactive in 78% of 91 patients with uncertain or very weak anti-HCV. It became on average positive at day 37 with seroconversion panels. CONCLUSIONS This multicentric, international study with >12,000 samples show that the new VIDAS anti-HCV assay is very suitable for screening and confirmation of HCV infection. Sensitivity, specificity and recognition of seroconversion compare favorably with well-established CE-marked tests and help to clarify discrepant results obtained with other assays.
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Affiliation(s)
- B Seignères
- bioMérieux, R&D Immunoassays, Marcy l'Etoile, France.
| | | | - R Croise
- EFS Rhône-Alpes, Metz-Tessy, France
| | - V Barlet
- EFS Rhône-Alpes, Metz-Tessy, France
| | - M Bouvier-Alias
- National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France
| | - S Chevaliez
- National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France
| | - J M Pawlotsky
- National Reference Center for Viral Hepatitis B, C and Delta, Department of Virology, Henri Mondor Hospital, Université Paris-Est, INSERM U955, Créteil, France
| | - W Abdelhady
- Clinical Pathology Department, Ain Shams Faculty of Medecine, Cairo, Egypt
| | - M Rafik
- Clinical Pathology Department, Ain Shams Faculty of Medecine, Cairo, Egypt
| | - A M Avellon
- National Centre of Microbiology, Department of Virology, Majadahonda, Spain
| | - J M Echevarria
- National Centre of Microbiology, Department of Virology, Majadahonda, Spain
| | - M Hausmann
- bioMérieux, R&D Immunoassays, Marcy l'Etoile, France
| | - J-M Dugua
- bioMérieux, R&D Immunoassays, Marcy l'Etoile, France
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Li D, Zhu S, Wang T, An J, Wang L, Tao C. Comparison of Elecsys Anti-HCV II Assay With Other HCV Screening Assays. J Clin Lab Anal 2015; 30:451-6. [PMID: 26667603 DOI: 10.1002/jcla.21878] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2014] [Accepted: 07/11/2015] [Indexed: 02/05/2023] Open
Abstract
OBJECTIVE Early detection of hepatitis C virus (HCV) is an important step in preventing progression to cirrhosis and hepatocellular carcinoma. Serologic assays for anti-HCV antibody are valuable first-line tests in the screening and diagnosis of HCV infection. This study's aim was to evaluate the sensitivity and specificity of Elecsys Anti-HCV II assay for HCV screening. DESIGN AND METHODS A total of 1,044 routine sera, 20 known HCV-positive samples, plus 54 preselected weakly positive samples were tested for anti-HCV with Elecsys Anti-HCV II assay, Elecsys Anti-HCV assays, InTec HCV enzymoimmunoassay (EIA), and Livzon Anti-HCV EIA. Interference test was assessed with additional 423 specimens without clinical evidence of HCV infection: preselected HCV weak reactive samples; dialysis samples; anti-HBc (antibody to HBV core antigen) (+), anti-Treponema pallidum (+), and anti-HIV (+) sera; and samples form autoimmune/alcoholic hepatitis or systemic Lupus erythematosus (SLE). Discrepant results were evaluated with recombinant immunoblot assay. The seroconversion panels were evaluated to assess how early each assay could detect HCV infection. RESULTS The specificity (99.81%) of the Elecsys Anti-HCV II assay was less than that with the two EIA comparison methods. However, false-negative results were easily seen in the EIA assays. When serial bleeds of HCV panels were compared with the above-mentioned methods, the assay detected acute HCV infection only 3.5 days after a positive HCV-RNA nucleic acid test and earlier than the comparator assays. CONCLUSION Sensitivities and specificities of the anti-HCV assays were sufficiently high for use in this study. The Elecsys Anti-HCV II assay is suitable for screening and reliable early detection of HCV infection.
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Affiliation(s)
- Dongdong Li
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
| | - Siyuan Zhu
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
| | - Tingting Wang
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
| | - Jingna An
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
| | - Lanlan Wang
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China
| | - Chuanmin Tao
- Division of Clinical Microbiology, Department of Laboratory Medicine, West China Hospital, Sichuan University, Chengdu, P.R. China.
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Li HC, Lo SY. Hepatitis C virus: Virology, diagnosis and treatment. World J Hepatol 2015; 7:1377-1389. [PMID: 26052383 PMCID: PMC4450201 DOI: 10.4254/wjh.v7.i10.1377] [Citation(s) in RCA: 108] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2014] [Revised: 12/22/2014] [Accepted: 04/02/2015] [Indexed: 02/06/2023] Open
Abstract
More than twenty years of study has provided a better understanding of hepatitis C virus (HCV) life cycle, including the general properties of viral RNA and proteins. This effort facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. Quantization and genotyping of HCV RNAs are important to determine the optimal duration of anti-viral therapy and predict the likelihood of response. In the early 2000s, pegylated interferon plus ribavirin became the standard anti-HCV treatment. However, this therapy is not ideal. To 2014, boceprevir, telaprevir, simeprevir, sofosbuvir and Harvoni are approved by Food and Drug Administration for the treat of HCV infections. It is likely that the new all-oral, interferon-free, pan-genotyping anti-HCV therapy will be available within the next few years. Majority of HCV infections will be cured by these anti-viral treatments. However, not all patients are expected to be cured due to viral resistance and the high cost of antiviral treatments. Thus, an efficient prophylactic vaccine will be the next challenge in the fight against HCV infection.
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Yoo SJ, Wang LL, Ning HC, Tao CM, Hirankarn N, Kuakarn S, Yang R, Han TH, Chan RC, Hussain BM, Hussin H, Muliaty D, Shen L, Liu H, Wei L. Evaluation of the Elecsys(®) Anti-HCV II assay for routine hepatitis C virus screening of different Asian Pacific populations and detection of early infection. J Clin Virol 2014; 64:20-7. [PMID: 25728074 DOI: 10.1016/j.jcv.2014.12.015] [Citation(s) in RCA: 15] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/11/2014] [Revised: 12/12/2014] [Accepted: 12/23/2014] [Indexed: 02/05/2023]
Abstract
BACKGROUND Early diagnosis of hepatitis C virus (HCV) infection is essential to allow appropriate treatment and prevent transmission. OBJECTIVES To evaluate the Elecsys(®) Anti-HCV II assay as a routine screening assay in Asia using a large number of samples from different Asian Pacific populations and compare its performance with other HCV assays routinely used in the region. STUDY DESIGN The sensitivity and specificity of the Elecsys(®) Anti-HCV II assay were determined using routine hospital samples and compared with at least one of the following comparator assays at nine independent centers: ARCHITECT™ Anti-HCV; Serodia(®)-HCV Particle Agglutination; Vitros(®) ECi Anti-HCV; Elecsys(®) Anti-HCV; ADVIA Centaur(®) HCV; InTec(®) HCV EIA; or Livzon(®) Anti-HCV. Commercially available seroconversion panels were used to assess sensitivity for early detection of infection. RESULTS The Elecsys(®) Anti-HCV II assay was more sensitive in recognizing early infection and detected acute HCV infection earlier on average than the comparator assays for all six panels tested. 7,726 routine samples were tested and 322 identified as HCV positive. Elecsys(®) Anti-HCV II had a sensitivity of 100% and a specificity of 99.66%, both of which were comparable or superior to the results obtained for competitor assays, which ranged from 87.5-100% and 98.98-100%, respectively. CONCLUSIONS The Elecsys(®) Anti-HCV II assay has the sensitivity and specificity to support its use as a routine screening method in the Asia Pacific region. Furthermore, this assay shortens the diagnostic window between infection and the detection of antibodies compared with established methods.
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Affiliation(s)
- Soo Jin Yoo
- Inje University Sanggye Paik Hospital, 1342, Dongilro, Nowon-gu, Seoul 139-707, South Korea.
| | - Lan Lan Wang
- West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China.
| | - Hsiao-Chen Ning
- Chang Gung Memorial Hospital, 5 Fusing Street, Gueishan Township, Taoyuan County 333, Taiwan ROC.
| | - Chuan Min Tao
- West China Hospital, Sichuan University, 37 GuoXue Xiang, Chengdu, Sichuan Province 610041, China.
| | - Nattiya Hirankarn
- Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, 1873 Rama Road, Pathumwan, Bangkok 10330, Thailand.
| | - Sunida Kuakarn
- Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, 1873 Rama Road, Pathumwan, Bangkok 10330, Thailand.
| | - Ruifeng Yang
- Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Xizhimen South Street No 11, Xicheng District, Beijing 100044, China.
| | - Tae Hee Han
- Inje University Sanggye Paik Hospital, 1342, Dongilro, Nowon-gu, Seoul 139-707, South Korea.
| | - Raymond C Chan
- Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia.
| | - Baizurah Mohd Hussain
- Hospital Ampang, Jalan Mewah Utara, Pandan Mewah, 68000 Ampang, Selangor DE, Malaysia.
| | - Hazilawati Hussin
- Hospital Ampang, Jalan Mewah Utara, Pandan Mewah, 68000 Ampang, Selangor DE, Malaysia.
| | - Dewi Muliaty
- Prodia Clinical Laboratory, Kramat Raya Street No. 150, Jakarta 10430, Indonesia.
| | - Lisong Shen
- Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, 1665 Kong Jiang Road, Shanghai 200092, China.
| | - Hongjing Liu
- Xin Hua Hospital, Shanghai Jiao Tong University School of Medicine, 1665 Kong Jiang Road, Shanghai 200092, China.
| | - Lai Wei
- Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Xizhimen South Street No 11, Xicheng District, Beijing 100044, China.
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Uliana CV, Riccardi CS, Yamanaka H. Diagnostic tests for hepatitis C: Recent trends in electrochemical immunosensor and genosensor analysis. World J Gastroenterol 2014; 20:15476-15491. [PMID: 25400433 PMCID: PMC4229514 DOI: 10.3748/wjg.v20.i42.15476] [Citation(s) in RCA: 23] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/07/2013] [Revised: 02/19/2014] [Accepted: 06/13/2014] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C is a liver disease that is transmitted through contact with the blood of an infected person. An estimated 150 million individuals worldwide have been chronically infected with the hepatitis C virus (HCV). Hepatitis C shows significant genetic variation in the global population, due to the high rate of viral RNA mutation. There are six variants of the virus (HCV genotypes 1, 2, 3, 4, 5, and 6), with 15 recorded subtypes that vary in prevalence across different regions of the world. A variety of devices are used to diagnose hepatitis C, including HCV antibody test, HCV viral load test, HCV genotype test and liver biopsy. Rapid, inexpensive, sensitive, and robust analytical devices are therefore essential for effective diagnosis and monitoring of disease treatment. This review provides an overview of current electrochemical immunosensor and genosensor technologies employed in HCV detection. There are a limited number of publications showing electrochemical biosensors being used for the detection of HCV. Due to their simplicity, specificity, and reliability, electrochemical biosensor devices have potential clinical applications in several viral infections.
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Maasoumy B, Bremer B, Raupach R, Lehmann P, Manns MP, Cornberg M, Wedemeyer H. How to interpret borderline HCV antibody test results: a comparative study investigating four different anti-HCV assays. Viral Immunol 2014; 27:7-13. [PMID: 24494968 DOI: 10.1089/vim.2013.0064] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022] Open
Abstract
Anti-HCV testing is the first step to diagnose hepatitis C. Although anti-HCV assay performance improved during the last 2 decades, very high sensitivity required for screening may lead to limitations in specificity. Thus, there remains an uncertainty how to interpret anti-HCV test results with a borderline signal-to-cut-off ratio. Comparison was made of concordance and performance of four licensed anti-HCV assays in samples with borderline signal-to-cut-off ratios. Out of 12,090 consecutive samples tested for anti-HCV with the Abbott Architect Anti-HCV assay over a period of 29 months, 95 plasma samples with a signal-to-cut-off ratio between 0.5 and 2 were selected for this study. All samples were re-tested with the Enzygnost Anti-HCV version 4.0, the Ortho anti-HCV version 3.0, and the Monolisa anti-HCV-Plus version 2 assays. Discordant samples were classified by additional immunoblot testing. Overall, only 52% of the Architect borderline samples gave similar results in all four assays. Inter-assay concordance ranged between 58% and 80%. The highest discordance was observed between the Architect and the Monolisa assay (42%). In contrast, a high level of concordance was found between the Enzygnost and Ortho assays (80%). The Monolisa was best to identify negative samples (100%), while the Enzygnost correctly classified most of the positive samples (96%). Anti-HCV antibody assays show significant variation in classifying samples with low signal-to-cut-off ratios. Different performances may have cost and management implications, as false-positive results are not infrequent. However, sensitivities were good for all assays if indeterminate results are not considered as negative.
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Affiliation(s)
- Benjamin Maasoumy
- Department for Gastroenterology, Hepatology and Endocrinology; Hannover Medical School , Hannover, Germany
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Saludes V, González V, Planas R, Matas L, Ausina V, Martró E. Tools for the diagnosis of hepatitis C virus infection and hepatic fibrosis staging. World J Gastroenterol 2014; 20:3431-3442. [PMID: 24707126 PMCID: PMC3974510 DOI: 10.3748/wjg.v20.i13.3431] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/27/2013] [Revised: 12/05/2013] [Accepted: 03/06/2014] [Indexed: 02/06/2023] Open
Abstract
Hepatitis C virus (HCV) infection represents a major public health issue. Hepatitis C can be cured by therapy, but many infected individuals are unaware of their status. Effective HCV screening, fast diagnosis and characterization, and hepatic fibrosis staging are highly relevant for controlling transmission, treating infected patients and, consequently, avoiding end-stage liver disease. Exposure to HCV can be determined with high sensitivity and specificity with currently available third generation serology assays. Additionally, the use of point-of-care tests can increase HCV screening opportunities. However, active HCV infection must be confirmed by direct diagnosis methods. Additionally, HCV genotyping is required prior to starting any treatment. Increasingly, high-volume clinical laboratories use different types of automated platforms, which have simplified sample processing, reduced hands-on-time, minimized contamination risks and human error and ensured full traceability of results. Significant advances have also been made in the field of fibrosis stage assessment with the development of non-invasive methods, such as imaging techniques and serum-based tests. However, no single test is currently available that is able to completely replace liver biopsy. This review focuses on approved commercial tools used to diagnose HCV infection and the recommended hepatic fibrosis staging tests.
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Yang R, Guan W, Wang Q, Liu Y, Wei L. Performance evaluation and comparison of the newly developed Elecsys anti-HCV II assay with other widely used assays. Clin Chim Acta 2013; 426:95-101. [DOI: 10.1016/j.cca.2013.09.010] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/08/2013] [Revised: 09/10/2013] [Accepted: 09/10/2013] [Indexed: 02/05/2023]
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Torresi J, Johnson DF, Leder K. Response to letters. J Travel Med 2013; 20:409-10. [PMID: 24165388 DOI: 10.1111/jtm.12068_2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/29/2022]
Affiliation(s)
- Joseph Torresi
- Department of Infectious Diseases, Austin Hospital, Heidelberg, Victoria, Australia; Victorian Infectious Diseases Service, Royal Melbourne Hospital, Parkville, Victoria, Australia
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Esteban JI, van Helden J, Alborino F, Bürgisser P, Cellerai C, Pantaleo G, Eiras A, Rodriguez MI, Ghisetti V, Gleich M, Imdahl R, Kaiser C, Möller P, Wetlitzky O, Segovia M, Schennach H, Mühlbacher A. Multicenter evaluation of the elecsys® anti-HCV II assay for the diagnosis of hepatitis C virus infection. J Med Virol 2013; 85:1362-8. [DOI: 10.1002/jmv.23536] [Citation(s) in RCA: 18] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 01/03/2013] [Indexed: 01/08/2023]
Affiliation(s)
- Juan I. Esteban
- Liver Unit; Vall d'Hebron University Hospital; Barcelona Spain
- Networked Biomedical Research Center Hepatic and Digestive Diseases (CIBEREHD); Institute of Health Carlos III; Madrid Spain
| | | | - Flora Alborino
- Dolo Hospital; Laboratory Medicine Local Health Unit 13; Dolo Italy
| | - Philippe Bürgisser
- Division of Immunology and Allergy, Department of Medicine and Laboratory Medicine; Centre Hospitalier Universitaire Vaudois; Lausanne Switzerland
| | - Cristina Cellerai
- Division of Immunology and Allergy, Department of Medicine and Laboratory Medicine; Centre Hospitalier Universitaire Vaudois; Lausanne Switzerland
| | - Giuseppe Pantaleo
- Division of Immunology and Allergy, Department of Medicine and Laboratory Medicine; Centre Hospitalier Universitaire Vaudois; Lausanne Switzerland
| | - Adolfo Eiras
- Transfusion Centre of Galicia; Santiago de Compostela; Spain
| | | | - Valeria Ghisetti
- Amedeo di Savoia Hospital; Laboratory of Microbiology and Virology; Turin Italy
| | - Michael Gleich
- Laboratory Schottdorf Medical Centre GmbH; Augsburg Germany
| | - Roland Imdahl
- Laboratory Schottdorf Medical Centre GmbH; Augsburg Germany
| | - Claudia Kaiser
- MVZ Laboratory Centre Munich Medical Care Centre; Munich Germany
| | - Petra Möller
- MVZ Laboratory Centre Munich Medical Care Centre; Munich Germany
| | - Olaf Wetlitzky
- MVZ Laboratory Centre Munich Medical Care Centre; Munich Germany
| | - Manuel Segovia
- Virgen de la Arrixaca Hospital; Laboratory Microbiology/Virology; Murcia Spain
| | - Harald Schennach
- Central Institute for Blood Transfusion and Immunology; Innsbruck Austria
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Enzyme-linked immunosorbent/chemiluminescence assays, recombinant immunoblot assays and nucleic acid tests in the diagnosis of HCV infection. Eur J Clin Microbiol Infect Dis 2013; 32:985-8. [PMID: 23666504 DOI: 10.1007/s10096-013-1857-1] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/16/2013] [Accepted: 03/05/2013] [Indexed: 12/21/2022]
Abstract
The diagnosis of hepatitis C virus (HCV) infection is defined according to the results obtained from screening assays, and confirmation made by supplemental tests, in order to exclude the possibility of false-positive and false-negative results and, therefore, a misdiagnosis. Identifying the patient's true clinical status is of crucial importance to direct an accurate course of therapy, but, often, the definition of this status is only possible after conjunctions and analysis of the results obtained from each methodology applied, considering the limitations of each assay. In this manuscript, it is discussed briefly the possible results obtained from the three methods most commonly applied in routine laboratory and their contribution in the diagnosis of HCV infection.
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Miyajima I, Kawaguchi T, Fukami A, Nagao Y, Adachi H, Sasaki S, Imaizumi T, Sata M. Chronic HCV infection was associated with severe insulin resistance and mild atherosclerosis: a population-based study in an HCV hyperendemic area. J Gastroenterol 2013; 48:93-100. [PMID: 22678465 DOI: 10.1007/s00535-012-0610-3] [Citation(s) in RCA: 34] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/30/2011] [Accepted: 05/01/2012] [Indexed: 02/04/2023]
Abstract
BACKGROUND Hepatitis C virus (HCV) affects glucose and lipid metabolism in vitro; however, it is unclear whether HCV infection is associated with insulin resistance and atherosclerosis at the population level. We aimed to investigate this association in a Japanese cohort of the Seven Countries Study, and our investigation was conducted in Tanushimaru, an HCV hyperendemic area. METHODS A total of 1908 inhabitants of Tanushimaru were classified into 3 groups according to HCV infection status: those who were uninfected (n = 1780), those with transient infection (n = 88), and those with chronic infection (n = 40). Insulin resistance and atherosclerosis were evaluated by homeostasis model assessment for insulin resistance (HOMA-IR) and carotid intima-media thickness (IMT), respectively. Intergroup differences in variables were evaluated by age- and sex-matched multivariate regression analysis. RESULTS Significant intergroup differences were seen in fasting glucose and insulin levels. The HOMA-IR value was significantly higher in the group with chronic infection than the values in the uninfected and transiently infected groups (3.0 ± 0.39 vs. 1.3 ± 0.03 vs. 1.5 ± 0.14; P < 0.001). In contrast, low-density lipoprotein (LDL)-cholesterol and triglyceride levels were significantly lower in the group with chronic infection than the levels in the other groups. IMT was reduced in the group with chronic infection, with a significant intergroup difference (0.67 ± 0.02 vs. 0.71 ± 0.003 vs. 0.72 ± 0.01 mm; P = 0.003). CONCLUSIONS This population-based study in an HCV hyperendemic area revealed that chronic HCV infection was associated with severe insulin resistance and with mild atherosclerosis, suggesting a unique characteristic of HCV-related metabolic abnormality.
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Affiliation(s)
- Ichiro Miyajima
- Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan
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Cabezas-Fernandez MT, Cabeza-Barrera MI. Introduction of an automated system for the diagnosis and quantification of hepatitis B and hepatitis C viruses. Open Virol J 2012; 6:122-34. [PMID: 23284598 PMCID: PMC3531716 DOI: 10.2174/1874357901206010122] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/09/2012] [Revised: 09/18/2012] [Accepted: 09/20/2012] [Indexed: 02/07/2023] Open
Abstract
Hepatitis B virus (HBV) and Hepatitis C virus (HCV) infections pose major public health problems because of their prevalence worldwide. Consequently, screening for these infections is an important part of routine laboratory activity. Serological and molecular markers are key elements in diagnosis, prognosis and treatment monitoring for HBV and HCV infections. Today, automated chemiluminescence immunoassay (CLIA) analyzers are widely used for virological diagnosis, particularly in high-volume clinical laboratories. Molecular biology techniques are routinely used to detect and quantify viral genomes as well as to analyze their sequence; in order to determine their genotype and detect resistance to antiviral drugs. Real-time PCR, which provides high sensitivity and a broad dynamic range, has gradually replaced other signal and target amplification technologies for the quantification and detection of nucleic acid. The next-generation DNA sequencing techniques are still restricted to research laboratories.The serological and molecular marker methods available for HBV and HCV are discussed in this article, along with their utility and limitations for use in Chronic Hepatitis B (CHB) diagnosis and monitoring.
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High prevalence of anti-HCV antibodies in two metropolitan emergency departments in Germany: a prospective screening analysis of 28,809 patients. PLoS One 2012; 7:e41206. [PMID: 22848445 PMCID: PMC3405124 DOI: 10.1371/journal.pone.0041206] [Citation(s) in RCA: 39] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/06/2012] [Accepted: 06/18/2012] [Indexed: 12/21/2022] Open
Abstract
Background and Aims The prevalence of hepatitis C virus (HCV) antibodies in Germany has been estimated to be in the range of 0.4–0.63%. Screening for HCV is recommended in patients with elevated ALT levels or significant risk factors for HCV transmission only. However, 15–30% of patients report no risk factors and ALT levels can be normal in up to 20–30% of patients with chronic HCV infection. The aim of this study was to assess the HCV seroprevalence in patients visiting two tertiary care emergency departments in Berlin and Frankfurt, respectively. Methods Between May 2008 and March 2010, a total of 28,809 consecutive patients were screened for the presence of anti-HCV antibodies. Anti-HCV positive sera were subsequently tested for HCV-RNA. Results The overall HCV seroprevalence was 2.6% (95% CI: 2.4–2.8; 2.4% in Berlin and 3.5% in Frankfurt). HCV-RNA was detectable in 68% of anti-HCV positive cases. Thus, the prevalence of chronic HCV infection in the overall study population was 1.6% (95% CI 1.5–1.8). The most commonly reported risk factor was former/current injection drug use (IDU; 31.2%) and those with IDU as the main risk factor were significantly younger than patients without IDU (p<0.001) and the male-to-female ratio was 72% (121 vs. 46 patients; p<0.001). Finally, 18.8% of contacted HCV-RNA positive patients had not been diagnosed previously. Conclusions The HCV seroprevalence was more than four times higher compared to current estimates and almost one fifth of contacted HCV-RNA positive patients had not been diagnosed previously.
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Park Y, Seok Y, Choi J, Kim HS. Performance evaluation of the Vitros anti-hepatitis C virus antibody assay for use in clinical laboratories. Clin Biochem 2012; 45:175-7. [DOI: 10.1016/j.clinbiochem.2011.10.020] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/12/2011] [Revised: 10/11/2011] [Accepted: 10/30/2011] [Indexed: 01/11/2023]
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Laboratory Diagnosis of Infection Due to Viruses, Chlamydia, Chlamydophila, and Mycoplasma. PRINCIPLES AND PRACTICE OF PEDIATRIC INFECTIOUS DISEASES 2012. [PMCID: PMC7152074 DOI: 10.1016/b978-1-4377-2702-9.00289-0] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Indexed: 11/18/2022]
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