Leticia de Paula Scalioni1, Helena Medina Cruz1, Vanessa Salete de Paula2, Juliana Custódio Miguel1, Vanessa Alves Marques1, Cristiane Alves Villela-Nogueira3, Flavio Augusto Pádua Milagres4, Marcelo Santos Cruz5, Francisco Inácio Bastos6, Tarcisio Matos Andrade7, Ana Rita Coimbra Motta-Castro8, Lia Laura Lewis-Ximenez1, Elisabeth Lampe1, Livia Melo Villar9. 1. Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. 2. Laboratory of Tecnhological Development of Virology, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. 3. Hepatology Division, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. 4. Medicine Faculty, Federal University of Tocantins, Palmas, Brazil. 5. Institute of Psychiatry, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil. 6. Institute of Communication and Scientific Information & Technology for Health, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil. 7. Department of Community & Family Health, Federal University of Bahia, Salvador, Brazil. 8. Department of Biochemistry and Pharmacy, Federal University of Mato Grosso do Sul, Campo Grande, MS, Brazil. 9. Laboratory of Viral Hepatitis, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil. Electronic address: lvillar@ioc.fiocruz.br.
Abstract
BACKGROUND: Rapid tests for the detection of antibodies to hepatitis C virus (anti-HCV) can facilitate access to diagnosis. OBJECTIVES: 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. STUDY DESIGN: 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. CONCLUSION: All of the rapid tests could be used to identify active HCV infection among individuals with different endemicity profiles and risk behaviors.
BACKGROUND: Rapid tests for the detection of antibodies to hepatitis C virus (anti-HCV) can facilitate access to diagnosis. OBJECTIVES: 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. STUDY DESIGN: 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. CONCLUSION: All of the rapid tests could be used to identify active HCV infection among individuals with different endemicity profiles and risk behaviors.
Authors: Curt G Beckwith; Ann E Kurth; Lauri B Bazerman; Emily J Patry; Alice Cates; Liem Tran; Amanda Noska; Irene Kuo Journal: J Public Health (Oxf) Date: 2015-03-02 Impact factor: 2.341
Authors: Helena Medina Cruz; Leticia de Paula Scalioni; Vanessa Salete de Paula; Elisangela Ferreira da Silva; Kycia Maria Rodrigues do Ó; Flavio Augusto Pádua Milagres; Marcelo Santos Cruz; Francisco Inácio Bastos; Priscila Pollo-Flores; Erotildes Leal; Ana Rita Coimbra Motta-Castro; José Henrique Pilotto; Lia Laura Lewis-Ximenez; Elisabeth Lampe; Livia Melo Villar Journal: BMC Infect Dis Date: 2015-11-30 Impact factor: 3.090