title: Prospective assessment of rapid diagnostic tests for the detection of antibodies to hepatitis C virus, a tool for improving access to care.
abstract: Large-scale hepatitis C screening is required to prevent further spread of the infection, improve access to care in the context of new hepatitis C virus (HCV) drug regimens without interferon-alpha and subsequently reduce the risk of long-term complications of chronic liver disease. Rapid diagnostic tests (RDTs) represent an attractive alternative to enzyme immunoassay using blood from venepuncture. The aim of the present study was to prospectively assess the clinical performance of CE-marked RDTs detecting anti-HCV antibodies in fingerstick capillary whole blood and/or oral fluid. A total of 513 individuals, including 318 patients with chronic HCV infection, 25 patients with resolved HCV infection and 170 HCV-seronegative individuals, were prospectively enrolled. The specificity of RDTs with fingerstick whole blood varied from 98.8% to 100%. The clinical sensitivity was high for the OraQuick(®) and Toyo(®) tests (99.4% and 95.8%, respectively), but low for the Labmen(®) test (63.1%). The specificity and clinical sensitivity in crevicular fluid were both satisfactory for the OraQuick(®) test (100% and 97.6%, respectively). HCV antibody RDTs were easy and rapid to perform in the context of patient care. They were highly specific. Both the OraQuick(®) and Toyo(®) tests reached the expected level of performance for wide-scale use, with a performance advantage for the OraQuick(®) HCV test. RDTs appear to be a promising new tool for wide-scale screening of HCV infection in high-risk to medium-risk populations. Hence, careful assessment of the performance of HCV RDTs must be recommended before they can be implemented in clinical practice.
authors.affiliation: National Reference Centre for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France. Electronic address: stephane.chevaliez@aphp.fr.
authors.forename: S
authors.initials: S
authors.lastname: Chevaliez
authors.affiliation: National Reference Centre for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France.
authors.forename: L
authors.initials: L
authors.lastname: Poiteau
authors.affiliation: Department of Hepatology and Gastroenterology, Centre Inter-communal de Créteil, Créteil, France.
authors.forename: I
authors.initials: I
authors.lastname: Rosa
authors.affiliation: National Reference Centre for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France.
authors.forename: A
authors.initials: A
authors.lastname: Soulier
authors.affiliation: INSERM U955, Créteil, France; Department of Public Health, hôpital Henri Mondor, Université Paris-Est, Créteil, France.
authors.forename: F
authors.initials: F
authors.lastname: Roudot-Thoraval
authors.affiliation: National Reference Centre for Viral Hepatitis B, C and delta in Blood Transfusion, Institut National de la Transfusion Sanguine, Paris, France.
authors.forename: S
authors.initials: S
authors.lastname: Laperche
authors.affiliation: INSERM U955, Créteil, France; Department of Hepatology and Gastroenterology, hôpital Henri Mondor, Université Paris-Est, Créteil, France.
authors.forename: C
authors.initials: C
authors.lastname: Hézode
authors.affiliation: National Reference Centre for Viral Hepatitis B, C and delta, Department of Virology, hôpital Henri Mondor, Université Paris-Est, Créteil, France; INSERM U955, Créteil, France.
authors.forename: J-M
authors.initials: JM
authors.lastname: Pawlotsky
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001769:Blood / Q000276:immunology; D002846:Chromatography, Affinity / Q000379:methods*; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D005883:Gingival Crevicular Fluid / Q000276:immunology; D016174:Hepacivirus / Q000276:immunology*; D018937:Hepatitis C Antibodies / Q000032:analysis* / Q000097:blood*; D019698:Hepatitis C, Chronic / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D019095:Point-of-Care Systems; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D055815:Young Adult
chemical_list: D018937:Hepatitis C Antibodies
keywords: Anti-hepatitis C virus antibodies; capillary whole blood; crevicular fluid; hepatitis C; rapid diagnostic test; screening