Academic literature on the topic 'Statens Serum Institut'

The efficacy of the Statens Serum Institut (SSI) enteric medium for isolation and direct identification of enteric pathogens was evaluated. Six different biochemical reactions can be read by using the SSI enteric medium, allowing direct identification of a range of enteric pathogens. All 248 gram-negative bacterial species that were tested grew on the SSI enteric medium. Only 10 of 248 bacteria (4%) showed discrepant results in the biochemical reactions, and none of these were enteric pathogens. Forty-three of 47 enteric pathogens (92%) produced identical rates of semiquantitative growth on the SSI enteric medium and 5% blood agar, whereas three Vibrio spp. and oneAeromonas spp. showed reduced growth. Gram-positive bacteria did not grow on the SSI enteric medium. Most enteric pathogens had a detection limit of 50 bacteria per ml of feces, but higher numbers of Vibrio spp. and some Shigella spp. were required for detection. The growth rates of 125 enteric pathogens and 12 Yersinia spp. on the SSI enteric medium, xylose lysine deoxycholate (XLD), Hektoen enteric (HE),Salmonella-Shigella (SS), and cefsulodin-irgasan-novobiocin (CIN) agar were compared. Detection rates after application of 200 CFU were 99% for SSI enteric medium, 92% for XLD, 88% for HE, and 82% for SS agar. The 12 Yersinia spp. grew excellently on both the SSI enteric medium and CIN agar. We conclude that the performance of the SSI enteric medium compares favorably to those of other media tested. Its ability to detect Yersinia spp. may limit the number of media needed in the typical laboratory. The direct identification of enteric pathogens on the medium may also provide a more rapid diagnosis.

The Danish meningococcal disease laboratory surveillance system was established in 1974, based on close collaboration between local Departments of Clinical Microbiology and the Reference Laboratory at Statens Serum Institut. The completeness of the clinical notification system integrated with the laboratory surveillance system has been estimated to be more than 95%. Overall 4257 (79%) of 5356 cases of meningococcal disease notified during 1974–1999 were confirmed by culture of Neisseria meningitidis. The proportion of culture-confirmed cases ranged from 70% in 1989 to 89% in 1980. Only 26 patients (0·6%) with culture-confirmed meningococcal disease were not notified. Serological phenotype and susceptibility to penicillin and sulphonamide were determined for all isolates. Multilocus enzyme electrophoresis and/or DNA-based analyses were used for the assessment of clusters and outbreaks. Meningococcal antibody tests and counter-immunoelectrophoresis were used for the ascertainment of suspected cases. These combined systems allowed timely and reliable management of outbreaks and identification of clusters.

Isavuconazole (ISZ) is used in the treatment of aspergillosis and mucormycosis. The purpose of this study was to evaluate the therapeutic drug monitoring (TDM) of ISZ samples from a clinical setting performed at Statens Serum Institut. Materials/methods: Isavuconazole serum concentrations were determined by fluorescent detection on a UHPLC. Serum-ISZ (s-ISZ) results were included and compared to those of serum-voriconazole (s-VRZ) in a 33 month period from March 2017. Clinical data were obtained for patients receiving ISZ. The therapeutic range was initially 2–10 mg/L, but was adjusted to 2–5 mg/L during the study period except for selected patients with Mucorales infections who received off-label doses of ISZ. Results: A total of 273 s-ISZ and 1242 s-VRZ measurements from 35 and 283 patients, respectively, were included. Seventeen patients had received both ISZ and VRZ with TDM within the study period. The median s-ISZ was 4.3 mg/L (0.5–15.4 mg/L) with 83% of measurements within the therapeutic index. The median s-VRZ was 2.6 mg/L (0.2–21.9 mg/L) with 67% of measurements within the therapeutic index. The median intra-/interindividual coefficient of variation (CV) was 43.4%/54.8% for ISZ compared to 53.2%/83.3% for VRZ. For patients receiving ISZ, the adverse events were mostly gastroenteric and few drug–drug interactions were observed. Furthermore, immediate change from ISZ to VRZ treatment seemed to lead to prolonged metabolism of ISZ with detection up to 35 days after discontinuation. Conclusions: The majority of patients achieved s-ISZ levels well within the therapeutic range with less intra/interindividual CV than patients receiving VRZ.

Upon HIV infection diagnosis, an 8-month-old boy was transferred for evaluation of worsening respiratory distress requiring mechanical ventilation.Pneumocystis jiroveciipneumonia (PCP) was diagnosed; the boy also had a nonhealing ulcer at the site of vaccination with Statens Serum Institut (Danish strain) Bacillus Calmette-Guérin (BCG) vaccine and associated axillary lymphadenopathy. PCP treatment resulted in weaning from mechanical ventilation. Antimycobacterial treatment was immediately attempted but was discontinued because of hepatotoxicity. Over several months, he developed splenic lesions and then disseminated skin and cystic bone lesions.M. boviswas repeatedly cultured from both skin and bone lesions despite various multidrug antimycobacterial regimens which included linezolid. Eventually, treatment with a regimen of rifabutin, isoniazid, ethambutol, and linezolid led to definitive cure. Clinicians should consider a linezolid-containing regimen for treatment of severe disseminated BCG infection, especially if other drug regimens have failed. Although drug toxicity is a particular concern for young children, this patient received linezolid for 13 months without serious toxicity. This case also highlights the need for universal screening among pregnant women to prevent vertical transmission of HIV. Finally, routine immunization with BCG vaccine at birth should be questioned in countries with low and declining burden of tuberculosis.

Abstract Approximately one third of the world’s population is infected with Mycobacterium tuberculosis. Developing novel vaccines to protect against pulmonary tuberculosis is a public health priority. In this study, a Hybrid 1 (H1) subunit vaccine containing a recombinant fusion protein of Ag85B and ESAT-6 was paired with a two-component CAF01 liposomal adjuvant system developed and manufactured by Statens Serum Institut. A phase I clinical study was performed to evaluate H1:CAF01 in healthy non-BCG vaccinated adult male and female subjects between the ages of 18 and 55 years old. The subjects were randomized into four groups including H1 alone or H1 with 125/25µg, 313/125µg or 625/125µg CAF01 and were vaccinated on study days 0 and 56. PBMCs harvested approximately 150 weeks post vaccination were used to assess antigen specific responses by a 13-color intracellular cytokine staining assay. Vaccination with H1:CAF01 resulted in statistically significant Ag85B-specific CD4 polyfunctional CD154+ T cells compared to H1 alone. ESAT-6 stimulation resulted in detection of CD4 polyfunctional CD154+ T cells responses that were not elevated to a statistically significant extent compared to H1 alone. This is the first demonstration of the persistence of an antigen-specific cellular immune response up to 3 years after vaccination in a clinical trial using H1:CAF01 vaccination.

Global immunization campaigns have resulted in a major decline in the global incidence of polio cases, with wild-type poliovirus remaining endemic in only two countries. Live oral polio vaccine (OPV) played a role in the reduction in polio case numbers; however, the risk of OPV developing into circulating vaccine-derived poliovirus makes it unsuitable for eradication programs. Trivalent inactivated polio virus (TIPV) vaccines which contain formalin-inactivated antigens produced from virulent types 1, 2 and 3 reference polio strains grown in Vero monkey kidney cells have been advocated as a replacement for OPV; however, TIPVs have weak immunogenicity and multiple boosts are required before peak neutralizing titers are reached. This study examined whether the incorporation of the novel polysaccharide adjuvant, Advax-CpG, could boost the immunogenicity of two TIPV vaccines, (i) a commercially available polio vaccine (IPOL®, Sanofi Pasteur) and (ii) a new TIPV formulation developed by Statens Serum Institut (SSI). Mice were immunized intramuscularly based on recommended vaccine dosage schedules and serum antibody titers were followed for 12 months post-immunization. Advax-CpG significantly enhanced the long-term immunogenicity of both TIPV vaccines and had at least a 10-fold antigen dose-sparing effect. An exception was the poor ability of the SSI TIPV to induce serotype type 1 neutralizing antibodies. Immunization with monovalent IPVs suggested that the low type 1 response to TIPV may be due to antigen competition when the type 1 antigen was co-formulated with the type 2 and 3 antigens. This study provides valuable insights into the complexity of the formulation of multivalent polio vaccines and supports the further development of adjuvanted antigen-sparing TIPV vaccines in the fight to eradicate polio.

The purpose of this study was to evaluate the potential value of different epithelial cell culture systems as in vitro models for studying corneal permeability. Transformed human corneal epithelial (HCE-T) cells and Statens Serum Institut rabbit corneal (SIRC) cells were cultured on permeable filters. SkinEthic human corneal epithelium (S-HCE) and Clonetics human corneal epithelium (C-HCE) were received as ready-to-use systems. Excised rabbit corneas (ERCs) and human corneas (EHCs) were mounted in Ussing chambers, and used as references. Barrier properties were assessed by measuring transepithelial electrical resistance, and by determining the apparent permeability of markers with different physico–chemical properties, namely, fluorescein, sodium salt; propranolol hydrochloride; moxaverine hydrochloride; timolol hydrogenmaleate; and rhodamine 123. SIRC cells and the S-HCE failed to develop epithelial barrier properties, and hence were unable to distinguish between the permeation markers. Barrier function and the power to differentiate compound permeabilities were evident with HCE-T cells, and were even more pronounced in the case of C-HCE, corresponding very well with data from ERCs and EHCs. A net secretion of rhodamine 123 was not observed with any of the models, suggesting that P-glycoprotein or similar efflux systems have no significant effects on corneal permeability. Currently available corneal epithelial cell culture systems show differences in epithelial barrier function. Systems lacking functional cell–cell contacts are of limited value for assessing corneal permeability, and should be critically evaluated for other purposes.

ABSTRACT The determination of Shiga toxin (ST) subtypes can be an important element in the risk characterization of foodborne ST-producing Escherichia coli (STEC) isolates for making risk management decisions. ST subtyping methods include PCR techniques based on electrophoretic or pyrosequencing analysis of amplicons and in silico techniques based on whole genome sequence analysis using algorithms that can be readily incorporated into bioinformatics analysis pipelines for characterization of isolates by their genetic composition. The choice of technique will depend on the performance characteristics of the method and an individual laboratory's access to specialized equipment or personnel. We developed two whole genome sequence–based ST subtyping tools: (i) an in silico PCR algorithm requiring genome assembly to replicate a reference PCR-based method developed by the Statens Serum Institut (SSI) and (ii) an assembly-independent routine in which raw sequencing results are mapped to a database of known ST subtype sequence variants (V-Typer). These tools were evaluated alongside the SSI reference PCR method and a recently described PCR-based pyrosequencing technique. The V-Typer method results corresponded closely with the reference method in the analysis of 67 STEC cultures obtained from a World Health Organization National Reference Laboratory. In contrast, the in silico PCR method failed to detect ST subtypes in several cases, a result which we attribute to assembly-induced errors typically encountered with repetitive gene sequences. The V-Typer can be readily integrated into bioinformatics protocols used in the identification and characterization of foodborne STEC isolates.

Abstract In 1958, Dr. P. von Magnus and his colleagues at the State Serum Institute in Copenhagen recovered an orthopoxviru:s from the skin lesions of a cynomolgus monkey during an outbreak of a pox disease in their laboratory monkeys. They noted that the pocks it produced on the chorioallantoic membrane were very similar to those produced by variola virus (although subs,equently differences were found), but unlike variola virus, the new virus produced large lesions in rabbit skin. It was a new orthopoxvirus, which they called “ monkeypox virus” . Over the next 10 years nine more outbreaks were recognized in captive primates in North America and Europe, all in monkeys shipped from Asia, except for a case in a chimpanzee very recently imported from Sierra Leone and a large outbreak in the Rotterdam Zoo in1964-1965 which was introduced by two South American anteaters. No cases occurred in animal handlers, and no cases were reported in captive monkeys after 1968.

Abstract The number of human embryonic stem cell lines currently available for research in the United States, some scientists, legislators, and commentators maintain, is insuffcient for research and therapeutic eVorts. They find that the policy of President George W. Bush of providing federal funding only for research on twenty-two embryonic stem cell lines derived before August 2001 has left researchers with too small a number of stem cell lines with which to go forward at a rapid pace. Furthermore, cells that are maintained in culture for a significant length of time tend to deteriorate, including those listed on the National Institutes of Health (NIH) registry. Many of these stem cell lines, although some say not all, have been cultured with nonhuman cells or serum that would pose health risks to patients who received differentiated offshoots from them in research or therapy. For such reasons, stem cell investigators are attempting to develop a larger pool of human pluripotent stem cells—cells that can transform into almost any cell of the body except placental tissue—by expanding the use of certain currently available sources of these cells and developing new sources.

A aplicação do Building Information Modelling (BIM) vem sendo impulsionada nacionalmente tanto pelo Decreto Nº 9.377, que determina a Estratégia Nacional de Disseminação do BIM, como pelo reconhecido potencial da metodologia como ferramenta para a melhoria de todo o ciclo de vida de um ativo. No entanto, o processo de adoção do BIM é desafiador pois demanda mudanças massivas em todas as esferas da organização. Os caminhos a serem seguidos dependem dos objetivos e procedimentos particulares de cada empresa. Isso reflete na necessidade da criação de uma estratégia assertiva alinhada aos planos de negócio e, para isso, é imprescindível a atuação de profissionais capacitados na metodologia BIM. Em contrapartida, acompanhando o mercado de trabalho e as pesquisas em relação ao ensino BIM, percebe-se que a formação na área ainda é sintética (BARISON, 2015; KASSEM e AMORIM, 2015; LEAL e SALGADO, 2019) e essa oferta ainda é bastante limitada. Diante dessa demanda latente, no ano de 2021 o Serviço Nacional de Aprendizagem Industrial (SENAI) por meio do Instituto SENAI de Tecnologia em Construção Civil desenvolveu o Programa de Residência em BIM. O programa é voltado tanto para construtoras, incorporadoras e escritórios de projetos (empresas patrocinadoras), quanto para profissionais graduados nas áreas de Arquitetura e Urbanismo ou Engenharia Civil (residentes). O propósito fundamental desse projeto é a difusão do BIM na indústria da construção civil e a capacitação de profissionais para liderar equipes, empresas e projetos, promovendo um ambiente adequado na adoção da ferramenta, acompanhando a implementação e o projeto em suas diferentes fases. Nessa direção, a abordagem da experiência de ensino apresentada foi teórico-prática, com aplicação e desenvolvimento do conhecimento teórico adquirido pelos residentes nas empresas patrocinadoras, contando com a mentoria contínua dos consultores Senai. Os mentores são especialistas BIM, com experiência na implantação da metodologia em grandes empresas e organizações de âmbito nacional. A mentoria englobou aulas teóricas e agenda semanal para sanar dúvidas dos residentes e orientar acerca dos próximos passos a serem tomados nas atividades práticas. A metodologia do programa de residência BIM foi desenvolvida sob uma base teórica de grande referência, que são os documentos estruturados por Bilal Succar e pela Penn State University, além disso, foi estritamente alinhada às demandas de mercado, seguindo as diretrizes já desenvolvidas e aplicadas pela equipe técnica do Centro de Referência BIM do SENAI desde 2018. As atividades da residência foram divididas em três módulos sequenciais e optativos, contemplando capacitação teórica e atividades práticas em todos eles. Módulo I: capacitação dos residentes e empresas e definições norteadoras de todo o processo de implantação e implementação BIM. Nessa fase foram estabelecidas as metas das empresas sobre a residência, os usos esperados do BIM e os meios necessárias para alcançar esses objetivos. Tais informações foram compiladas em um roadmap com estratégias de curto, médio e longo prazo. Este módulo gerou como resultado relatório de maturidade, mapeamento de processos e toda a documentação BIM. Módulo II: corresponde à prova de conceito para a fase de projeto. Nesta etapa, os documentos e padrões desenvolvidos foram aplicados e testados em um projeto piloto escolhido pela empresa, visando calibrar o processo de implementação às demandas reais e específicas da empresa. Nesse período, as atuações práticas foram intensificadas e o projeto piloto passou por todas as etapas dentro do fluxo BIM estabelecido. A interação com projetistas externos e demais envolvidos no fluxo de projeto também foi aferida. A capacitação nos softwares e plataformas escolhidas pela empresa aconteceu nesse momento, podendo envolver, a depender da demanda da empresa, os usos BIM de modelagem, coordenação 3D, compatibilização, estimativa de custos e planejamento. Módulo III: referente à prova de conceito na fase de obra. São avaliados questões e usos BIM relacionados à execução do empreendimento objeto do projeto piloto e pode envolver, conforme demanda da empresa, usos BIM no planejamento, princípios básicos do Lean Construction e acompanhamento de obra em BIM. A duração da residência varia de 9 a 24 meses, a depender da complexidade do projeto piloto escolhido e de quantos módulos a empresa deseja incorporar no processo. A modalidade de residência técnica é uma formação incomum dentro da área de AECO. A residência BIM propiciou uma capacitação, além de teórica, bastante prática em uma área inovadora com grande destaque profissional. As empresas, além de absorverem todo o processo de implementação BIM de maneira estruturada, personalizada e com suporte de especialistas SENAI, ao final do processo também têm disponível os profissionais residentes com qualificação totalmente alinhada as suas diretrizes e demandas específicas. Como trata-se de um projeto de capacitação atrelado à entrega de um produto (a implantação), não é possível afirmar que a modalidade de residência desenvolvida seja aderente a qualquer projeto, necessidade comercial ou perfil empresarial. A residência mostrou-se mais assertiva para empresas com um ritmo de absorção da metodologia menos acelerada, com duração de execução de projetos mais previsível e que buscam qualificar também sua equipe interna, uma vez que as capacitações exigem um tempo hábil e carga horária específica que não pode ser acelerada em função de mudanças muito significativas em prazos de entrega. Para empresas e projetos com prazos muito curtos ou com grandes variações de objetivo e prioridades, as consultorias de implantação convencionais podem mostrar-se uma solução mais aderente. O objetivo de capacitar profissionais mostrou-se atendido através das respostas de mercado. Os residentes BIM receberam propostas de trabalho de outros players antes mesmo do final da residência. O que corrobora com a grande demanda do mercado por profissionais com conhecimento na metodologia BIM, muito além da habilidade em modelagem 3D. Vale ressaltar que o afastamento de alguns residentes durante o processo não prejudicou as atividades, uma vez que, através das mentorias, novos residentes foram rapidamente inseridos no fluxo e foram capazes de dar sequência ao atendimento. Contudo, fica claro que a consolidação do Programa de Residência BIM do SENAI responde a uma demanda premente da indústria da construção civil no âmbito da melhoria permanente da oferta de mão de obra especializada, contribuindo assim, para a disseminação da metodologia BIM e impulsionamento do setor.