Primary screening of blood donors by nat testing for HCV-RNA: development of an "in-house" method and results

• Autor(a) principal: Wendel, Silvano
• Data de Publicação: 2007
• Outros Autores: Levi, José Eduardo, Takaoka, Deise Tihe, Silva, Isabela Cristina, Castro, Juliana Polachini de, Torezan-Filho, Mário A., Ghaname, Jorge, Gioachini, Romualdo, Brandão, Joselito, Durigon, Edison Luis
• Tipo de documento: Artigo
• Idioma: eng
• Título da fonte: Revista do Instituto de Medicina Tropical de São Paulo
• Texto Completo: https://www.revistas.usp.br/rimtsp/article/view/31086
• topic: Nucleic Acid Testing; Blood Donors; RT-PCR; Transfusional Risk; Hepatitis C Virus; HCV

An "in-house" RT-PCR method was developed that allows the simultaneous detection of the RNA of the Hepatitis C Virus (HCV) and an artificial RNA employed as an external control. Samples were analyzed in pools of 6-12 donations, each donation included in two pools, one horizontal and one vertical, permitting the immediate identification of a reactive donation, obviating the need for pool dismembering. The whole process took 6-8 hours per day and results were issued in parallel to serology. The method was shown to detect all six HCV genotypes and a sensitivity of 500 IU/mL was achieved (95% hit rate). Until July 2005, 139,678 donations were tested and 315 (0.23%) were found reactive for HCV-RNA. Except for five false-positives, all 310 presented the corresponding antibody as well, so the yield of NAT-only donations was zero, presenting a specificity of 99.83%. Detection of a window period donation, in the population studied, will probably demand testing of a larger number of donations. International experience is showing a rate of 1:200,000 - 1:500,000 of isolated HCV-RNA reactive donations.