title: Performance of rapid hepatitis C virus antibody assays among high- and low-risk populations.
abstract: BACKGROUND
  Rapid tests for the detection of antibodies to hepatitis C virus (anti-HCV) can facilitate access to diagnosis.
  
  
  OBJECTIVE
  This study aimed to evaluate the performance of rapid tests for anti-HCV detection in the sera, whole blood, and oral fluid samples from individuals with different endemicity profiles and risk behaviors.
  
  
  METHODS
  Three groups donated biological samples that were tested using three anti-HCV rapid tests (WAMA, Bioeasy and OraSure): (I) suspected cases of hepatitis C, (II) individuals who were living in remote areas in Brazil and (III) crack users and beauty professionals. Reproducibility, repeatability and cross-reactivity to other infectious agents (dengue, HIV, malaria, and syphilis) were also evaluated.
  
  
  RESULTS
  In group I, specificities varied from 93.75% to 100% and sensitivities varied from 76.03% to 93.84% according to the EIA results. When anti-HCV/HCV RNA-reactive sera samples were considered true-positive HCV cases, the sensitivities and specificities varied from 86.3% to 99.09% and 93.75% to 100%, respectively. In group II, the OraSure rapid test presented the best performance. In group III, the Bioeasy assay performed best using saliva and whole blood and the OraSure assay performed best using oral fluid samples. The reproducibility and repeatability of the WAMA and Bioeasy tests were excellent. The level of concordance between the HCV EIAs and the rapid tests using samples that were reactive for other infectious agents varied from 82.35% to 100% for the WAMA assay and 94.11% to 100% for the Bioeasy assay.
  
  
  CONCLUSIONS
  All of the rapid tests could be used to identify active HCV infection among individuals with different endemicity profiles and risk behaviors.
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Leticia de Paula
authors.initials: Lde P
authors.lastname: Scalioni
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Helena Medina
authors.initials: HM
authors.lastname: Cruz
authors.affiliation: Laboratory of Tecnhological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Vanessa Salete
authors.initials: VS
authors.lastname: de Paula
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Juliana Custódio
authors.initials: JC
authors.lastname: Miguel
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Vanessa Alves
authors.initials: VA
authors.lastname: Marques
authors.affiliation: Hepatology Division, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
authors.forename: Cristiane Alves
authors.initials: CA
authors.lastname: Villela-Nogueira
authors.affiliation: Medicine Faculty, Federal University of Tocantins, Palmas, Brazil.
authors.forename: Flavio Augusto Pádua
authors.initials: FA
authors.lastname: Milagres
authors.affiliation: Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.
authors.forename: Marcelo Santos
authors.initials: MS
authors.lastname: Cruz
authors.affiliation: Institute of Communication and Scientific Information & Technology for Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
authors.forename: Francisco Inácio
authors.initials: FI
authors.lastname: Bastos
authors.affiliation: Department of Community & Family Health, Federal University of Bahia, Salvador, Brazil.
authors.forename: Tarcisio Matos
authors.initials: TM
authors.lastname: Andrade
authors.affiliation: Department of Biochemistry and Pharmacy, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil.
authors.forename: Ana Rita Coimbra
authors.initials: AR
authors.lastname: Motta-Castro
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Lia Laura
authors.initials: LL
authors.lastname: Lewis-Ximenez
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lampe
authors.affiliation: Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. Electronic address: lvillar@ioc.fiocruz.br.
authors.forename: Livia Melo
authors.initials: LM
authors.lastname: Villar
mesh_terms: D000293:Adolescent; D000328:Adult; D001938:Brazil / Q000453:epidemiology; D003429:Cross Reactions / Q000276:immunology; D005260:Female; D016174:Hepacivirus / Q000276:immunology*; D006526:Hepatitis C / Q000175:diagnosis / Q000453:epidemiology / Q000276:immunology*; D018937:Hepatitis C Antibodies / Q000097:blood / Q000276:immunology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011159:Population Surveillance; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D016036:Seroepidemiologic Studies; D012698:Serologic Tests; D055815:Young Adult
chemical_list: D018937:Hepatitis C Antibodies
keywords: Diagnosis; Endemicity; Hepatitis C virus; Prevalence; Rapid test