Daniele Rocha

The Brazilian experience of nucleic acid testing to detect human immunodeficiency virus, hepatitis C virus, and hepatitis B virus infections in blood donors: BRAZILIAN NAT OF HIV, HCV, AND HBV

The history of the development and implementation of the Brazilian nucleic acid testing (NAT) platform to detect and discriminate among human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) infections in blood donors is described here. The results for the sensitivity, reproducibility, and NAT yield of the platform since program implementation are provided.

One-step real-time PCR assay for detection and quantification of RNA HCV to monitor patients under treatment in Brazil

The Brazilian Public Health Service provides freely αPEG-IFN to treat patients infected with HCV. The primary goal of HCV therapy is the long-term elimination of HCV from the blood to reduce the risk of HCV associated complications and death. Patient viremia affects the treatment duration and response, thus influencing clinical decisions. We developed a high-throughput method to perform the quantification of RNA hepatitis C virus (HCV) virus load in plasma samples to monitor patients under treatment. The method is based on a duplex detection, in a one-step real-time RT-PCR assay and it has been validated according to the rules established by the official Brazilian regulatory agency (ANVISA). This new method was compared to a commercial kit (Cobas/Taqman HCV Test v2.0 - Roche), showing virus load results with significant correlation between them (p = 0,012) using commercial and clinical panels. In addition, 611 samples from patients treated with peguilated alfa-interferon (αPEG-IFN) from different regions of Brazil were analyzed. Our one-step real-time RT-PCR assay demonstrated good performance in viral load measurement and in treatment course monitoring, with acceptable sensitivity and specificity values.

Transgênicos - Plantas Produtoras de Fármacos (PPF)

As Plantas Produtoras de Farmacos (PPF) representam a 4a onda de vegetais geneticamente modificados. Neste caso, com a tecnologia sendo empregada para desenvolver e produzir vacinas e/ou produtos farmaceuticos, a partir de plantas transgenicas. Esta tecnologia, como todas as inovacoes cientificas, vem acompanhada de riscos. Porem, o conhecimento atual disponivel sobre seu uso nao permite ainda conclusoes definitivas sobre o carater dos riscos, sua significância e sua probabilidade de causar, ou nao, serios danos. A analise de risco deve servir de base para a implementacao de inovacoes tecnocientificas. Os parâmetros devem ser avaliados, precaucoes especiais devem ser tomadas, a pesquisa deve ser conduzida de forma detalhada e tambem precisa ter amplo alcance quanto aos riscos potenciais por ser uma inovacao. O presente artigo revisou a aplicabilidade desta nova tecnologia com relacao ao gerenciamento do risco e a uma contencao que vise a seguranca de uso, a manipulacao e o comercio para os seres humanos.