ABSTRACT
The pandemic outbreak of coronavirus 2 (SARS-CoV-2), which began in China, is still ongoing in Brazil and worldwide, with over than 4.0 million confirmed cases and 280,000 deaths after 4 months of the virus spreading. It is now the top-priority pathogen to be dealt with due to its high transmissibility, severe illness and associated mortality, absence of effective prophylactic and therapeutic measures with knowledge gaps in human epidemiology, immunity and pathogenesis. To meet the increasing demand of the diagnostic and clinical services, it is necessary to improve biosafety and expand laboratory capabilities since the existing laboratories and workers cannot meet the emerging demand. This article highlights the risk class and biosafety consensus of the minimum requirements for the SARS-COV-2 clinical and diagnostic laboratories, as well as, the prevention of the biorisk to the workers, avoiding accidental dissemination to their families and the community.
A pandemia do Coronavírus 2 (SARS-CoV-2), iniciada na China, e ainda em curso no Brasil e mundo afora, já registra mais de 4,0 milhões de casos confirmados e mais de 280 mil óbitos após 4 meses de dispersão do vírus. É no momento o patógeno de maior prioridade a ser tratado, por ter alta transmissibilidade, associado à graves doenças e mortalidade, assim como, ausência de medidas profiláticas e terapêuticas eficazes, limitados conhecimentos da epidemiologia, imunidade e patogênese humana. Para acompanhar à crescente demanda dos serviços clínicos e diagnósticos, é necessário aprimorar a biossegurança e expandir a capacidades dos laboratórios e profissionais. O artigo destaca a classe de risco e os consensos dos requisitos mínimos de biossegurança para atividades em laboratórios clínicos e diagnósticos com o SARS-COV-2, assim como, a prevenção de riscos biológicos aos profissionais, evitando disseminação acidental às famílias e à comunidade.
ABSTRACT
O Brasil, desde 1996, com a implementação da Resolução CNS n. 196, entra no cenário mundial como importante país no aspecto regulatório das pesquisas com seres humanos, assim como, na organização do Sistema Nacional de Ética em Pesquisa com seres humanos. Novas demandas, ajustes e complementações do sistema ensejaram novas Resoluções: a CNS n. 466/2012 e a CNS n. 510/2016. O Sistema Nacional se baseia em uma autoridade nacional -Comissão Nacional de Ética em Pesquisa (Conep) - e autoridades locais os Comitês de Ética em Pesquisa CEPs. O artigo reflete a organização nacional da regulação ética em pesquisa e sugere a necessidade de sinergia entre as autoridades nacionais e institucionais. Ainda ilustra conceitos sobre a estrutura, funcionamento e principais desafios do atual sistema, pautado pelos princípios e as diretrizes éticas globalmente aceitas, não se limitando aos interesses do avanço científico e tecnológico em prol da vida e da saúde humana, mas, acima de tudo, no respeito e na proteção dos participantes de pesquisa.
Brazil, since 1996, with the implementation of the Resolution CNS n. 196, has risen an important global stage with regard the regulatory aspect of research involving human beings and the organization of the National System on Ethics in Human Research. New challenges, amendments and complements of the System led to new Resolutions, the CNS n. 466/2012 and the CNS n. 510/2016. The National System is based on the national authority -The National Commission for Research Ethics (Conep) -and the institutional authorities, the Research Ethics Committees (CEPs). The article reflects the national organization of ethical regulation in research, and suggests the need of synergy between the national and institutional authorities. It also illustrates concepts about the structure, functioning and main challenges of the current system, guided by the principles and ethical guidelines globally accepted, not just limited to the interests of scientific andtechnological advancement, but largely, on the respect and research participant protection.
Subject(s)
Humans , Ethics Committees, Research , Ethics, Research , Human Experimentation/ethics , Research Design/legislation & jurisprudence , Resolutions , Human Experimentation/legislation & jurisprudenceABSTRACT
Humoral and cellular immune responses of mice inoculated with recombinant Mycobacterium bovis BCG expressing the MSP1a antigen of Anaplasma marginale were evaluated. The msp1a gene was amplified by PCR and cloned into the mycobacterial expression vectors pUS2000 and pMIP12. Immunization of isogenic BALB/c mice with the rBCG/pUS2000-msp1a construct induced significant seroconversion to MSP1a (p<0.001), which was 26 times above pre-immunization levels at day 63 post-initial immunization and which remained stable for the duration of the experiment (6 months). In contrast, rBCG/pMIP12-msp1a induced seroconversion at a level of 6 times above pre-immunization values, which peaked at day 63. Western blot analysis showed that sera derived from mice vaccinated with either rBCG construct recognized both native and recombinant forms of A. marginale MSP1a. In contrast to the humoral response data, immunization with rBCG/pMIP12-msp1a was found to induce a markedly stronger cellular response than that recorded for BCG/pUS2000-msp1a. These observations clearly demonstrated the immunogenicity of recombinant BCG expressing the MSP1a antigen and suggested that the immune responses were influenced by the level of antigen expression. The results of this research warrant studies of recombinant M. bovis BCG expressing MSP1a in cattle to test for protective antibody production for control of bovine anaplasmosis.
Subject(s)
BCG Vaccine/immunology , Bacterial Outer Membrane Proteins/immunology , Mycobacterium bovis/immunology , Anaplasma marginale , Animals , Antibody Formation/immunology , BCG Vaccine/genetics , Bacterial Outer Membrane Proteins/biosynthesis , Bacterial Outer Membrane Proteins/genetics , Cattle , Cloning, Molecular , Female , Immunity, Cellular/immunology , Mice , Mice, Inbred BALB C , Mycobacterium bovis/geneticsABSTRACT
O cumprimento da legislacão que regulamenta a comercializacão de alimentos e ingredientes contendo Organismos Geneticamente Modificados (OGMs) é totalmente dependente da sensibilidade e confiabilidade dos métodos de deteccão e quantificacão de OGMs. Na presente revisão, foram discutidos os métodos mais relevantes para tais fins, especialmente aqueles que se baseiam na deteccão da proteína ou do DNA recombinante, destacando as suas principais propriedades, limitacões e vantagens. A regulamentacão e algumas sugestões de métodos alternativos para a deteccão de OGMs também são abordadas.
