Establishment of a Reference Material in Quality Control for Use in Infectivity and Identity Assays of Recombinant COVID-19 Vaccine, in Accordance with International Standards Organization Guidance.

The COVID-19 pandemic, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), began in 2019. One of the strategies for pandemic control was mass vaccination. In Brazil, the recombinant COVID-19 vaccine (RCV) was produced on a large scale and offered at no charge to the population. The specifications for quality control analyses of RCV included identity and infectivity determination. To validate the results, a reference material (RM) must be analyzed in parallel with the sample vaccine. This research aimed to establish the RM for use in the identity and infectivity assay for RCV. The candidate RM was analyzed using homogeneity and stability studies. The RM was considered homogeneous for identity (cycle threshold (Ct) ≤ 25.19) and infectivity (average x- was 9.25 log10 infectious units/mL). The RM was considered adequately stable for identity during the total period in all studies, being stable at -70, 5, and 22.5 °C for 380, 313, and 14 days, respectively (Ct ≤ 21.81). For infectivity, the RM was stable at -70, 5, and 22.5 °C for 380, 97, and three days, respectively. Since the property identity and infectivity values of the RM were established, the new RM could be used in quality control analysis.

Reference genes for gene expression profiling in mouse models of Listeria monocytogenes infection.

RT-qPCR dissects transcription-based processes but requires reference genes (RGs) for data normalization. This study prospected RGs for mouse macrophages (pMØ) and spleen infected with Listeria monocytogenes. The pMØ were infected in vitro with L. monocytogenes or vehicle for 4 h. Mice were injected with L. monocytogenes (or vehicle) and euthanized 24 h post-injection. The RGs came from a multispecies primer set, from the literature or designed here. The RG ranking relied on GeNorm, NormFinder, BestKeeper, Delta-CT and RefFinder. B2m-H3f3a-Ppia were the most stable RGs for pMØ, albeit RG indexes fine-tuned estimations of cytokine relative expression. Actß-Ubc-Ppia were the best RGs for spleen but modestly impacted the cytokine relative expression. Hence, mouse models of L. monocytogenes require context-specific RGs for RT-qPCR, thus reinforcing its paramount contribution to accurate gene expression profiling.

COVID-19 PCR: frequency of internal control inhibition in clinical practice.

Introduction: Diagnosis of COVID-19 (coronavirus disease 2019) is best performed with real-time (quantitative) PCR (qPCR), the most sensitive method for detection and quantification of viral RNA. Using the Centers for Disease Control and Prevention (CDC) protocol, for each sample tested for the virus, three qPCR tests are performed, targeting the viral genes N1 and N2, in addition to the internal control gene RNase P. Samples in which internal control fails to amplify should be labelled 'invalid'. Methods: This study aims to determine the frequency of inhibition of the RNase P gene used as an internal control in qPCR tests for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) in a reference hospital in Southern Brazil during the COVID-19 pandemic (1 February 2021 to 31 March 2021). Results: A total 10, 311 samples were available for analysis. The mean cycle threshold (Ct) value for the RNAse P gene was 26.65 and the standard deviation was 3.18. A total of 252 samples were inhibited (2.4%) during the study period: amongst these, 77 (30.5%) showed late amplifications (beyond 2 standard deviations from the mean Ct value), and 175 (69.4%) revealed no fluorescence at all for the RNase P gene. Conclusions: This study showed a low percentage of inhibition using RNase P as an internal control in COVID-19 PCRs using the CDC protocol, thus proving the effectiveness of this protocol for identification of SARS-CoV-2 in clinical samples. Re-extraction was efficacious for samples that showed little or no fluorescence for the RNase P gene.

Sistema automatizado para el control de medios de informática, ofimática y comunicaciones CIMIOC

Introducción: en las instituciones pertenecientes al Ministerio de Salud Pública de Cuba, la forma habitual de registrar el control de las Tecnologías de la Información y la Comunicación ha sido mediante hojas de Excel, procesadores de texto y fichas técnicas impresas. El control informatizado ofrece ventajas, pero las aplicaciones informáticas existentes a nivel mundial son costosas o no adaptables a los requerimientos. Objetivo: desarrollar una herramienta informática para el control institucional de medios informáticos, ofimáticos y de comunicaciones. Materiales y Métodos: investigación de desarrollo e innovación tecnológica, realizada durante 2018 y 2019, en dos etapas: 1) trabajo de mesa, definición de objetivos y establecimiento de pre-requisitos; 2) desarrollo de la aplicación, siguiendo la política de utilización de software libre. Las pruebas de funcionamiento y la evaluación se realizaron en la empresa MEDICuba S.A. Resultados: se desarrolló y registró una aplicación para el Control Informatizado de Medios de Informática, Ofimática y Comunicaciones (CIMIOC), con interfaz web, base de datos centralizada y un diseño adaptable a varios tipos de dispositivos. Permite registrar cualquier recurso de este tipo, su historial de movimiento, el estado técnico, los programas de mantenimiento y salvas de información, y ofrece diferentes reportes estadísticos. Conclusiones: la herramienta informática CIMIOC ofrece una solución robusta y económica para la gestión de las Tecnologías de la Información y las Comunicaciones, aplicable a cualquier institución. Facilita de manera objetiva el establecimiento de políticas que tributen a elevar los niveles de calidad en los servicios asociados a la utilización intensiva de estas tecnologías. Se recomienda generalizar la implantación en el Sistema Nacional de Salud.

Introduction: in the institutions belonging to the Ministry of Public Health of Cuba, the usual way of recording the control of Information and Communication Technologies has been through Excel sheets, word processors and printed technical sheets. Computerized control offers advantages, but existing computer applications worldwide are expensive or not adaptable to the requirements. Objective: to develop a computer tool for the institutional control of computer, office and communications media. Materials and Methods: technological development and innovation research, carried out during 2018 and 2019, in 2 stages: 1) table work, definition of objectives and establishment of pre-requisites. 2) development of the application, following the policy of use of free software. The performance tests and the evaluation were carried out in the company MEDICuba S.A. Results: an application for the Computerized Control of Informatics, Office Automation and Communications Media (CIMIOC) was developed and registered, with a web interface, centralized database and a design adaptable to various types of devices. It allows recording any resource of this type, its movement history, technical status, maintenance programs and information saves, and offers different statistical reports. Conclusions: the CIMIOC computer tool offers a robust and economical solution for ICT management, applicable to any institution. It objectively facilitates the establishment of policies that contribute to raising quality levels in services associated with the intensive use of ICT. Authors recommend to generalize the implementation in the National Health System.

Propuesta para la valoración de la gestión de riesgos de la COVID-19 con enfoque difuso / Proposal for valuation of the risk management of the COVID-19 with a diffuse / Proposta de avaliação da gestão de risco do COVID-19 com abordagem difusa

RESUMEN Introducción: el enfrentamiento a la COVID-19 impone importantes retos a los profesionales de la salud relacionados con los cuidados de la salud de la población y con la prevención y control de infecciones en la comunidad y en las instituciones de salud. Uno de los mayores retos a los que se enfrentan los hospitales es gestionar los riesgos sin que ello suponga un deterioro de la calidad percibida por el paciente y personal sanitario. Objetivo: diseñar un modelo para la gestión de riesgos epidemiológicos relacionado con la COVID-19 en consejos y unidades de salud. Métodos: se utilizó la Lógica Difusa Compensatoria como método pertinente de la modelación matemática en procesos complejos. Resultados: se tiene un modelo de decisión para la valoración de la gestión de riesgos relacionado con la COVID-19, integrado al sistema de control interno hospitalario. Conclusiones: se demostró la pertinencia de la gestión de riesgos como alternativa para exterminar la pandemia causada por el nuevo Coronavirus SARS CoV-2. Se confirma la pertinencia de la lógica difusa compensatoria para la toma de decisiones en proceso complejos. Se integró la gestión de riesgos de la COVID-19 al sistema de control interno hospitalario, permitiendo tomar estrategias para la mejora de las entidades de la salud.

ABSTRACT Introduction: the confrontation with COVID-19 imposes important challenges on health professionals related to the health care of the population and to the prevention and control of infections in the community and in health institutions. One of the biggest challenges that hospitals face is managing their risk more efficiently without this deteriorating the quality perceived by the patient and healthcare personnel. Objective: assessing the management of epidemiological risk related to COVID-19 in healt councils and units. Methods: compensatory fuzzy logic was used as a pertinent method of mathematical modeling in complex processes Results: there is a decision model for the assessment of risk management related to COVID-19, integrated into the hospital internal control system Conclusions: the relevance of risk management as an alternative to exterminate the pandemic caused by the new coronavirus SARS CoV-2was demonstrated. The pertinence of diffuse compensatory logic for decision making in complex processes is confirmed. The risk management of de covid was integrated into the hospital internal control system, allowing the desing of strategies for the improvement of health entities.

RESUMO Introdução: o enfrentamento da COVID-19 impõe desafios importantes para os profissionais de saúde relacionados à atenção à saúde da população e à prevenção e controle de infecções na comunidade e nas instituições de saúde. Um dos maiores desafios que os hospitais enfrentam é gerenciar os riscos sem causar uma deterioração na qualidade percebida pelo paciente e profissionais de saúde. Objetivo: traçarum modelo de gestão dos riscos epidemiológicos relacionados ao COVID-19 em conselhos e unidades de saúde. Métodos: A Lógica Fuzzy Compensatória foi utilizada como um método pertinente de modelagem matemática em processos complexos. Resultados: existe um modelo de decisão para avaliação do gerenciamento de riscos relacionado ao COVID-19, integrado ao sistema de controle interno do hospital. Conclusões: ficou demonstrada a relevância do gerenciamento de risco como alternativa para exterminar a pandemia causada pelo novo Coronavírus SARS CoV-2. A relevância da lógica fuzzy compensatória para a tomada de decisão em processos complexos é confirmada. A gestão de riscos do COVID-19 foi integrada ao sistema de controle interno do hospital, permitindo a adoção de estratégias de melhoria das entidades de saúde.

Sistema informático para un cuadro de mando integral del control interno como apoyo a la gestión de la información hospitalaria / Information system for an integrated internal control panel in support of hospital information management

En Cuba se ha identificado la necesidad de dominar y de introducir en la práctica las tecnologías de la información y las comunicaciones y de lograr una cultura digital como una de las características imprescindibles para los hospitales, lo cual sigue constituyendo un reto con múltiples aristas, enfoques y puntos de vistas. En este sentido se destaca el control interno como un motor de gestión de la información. Este trabajo tuvo como objetivo desarrollar un sistema informático para la automatización del cuadro de mando integral como herramienta de control interno en entidades hospitalarias, que contribuya a la gestión de la información en ciencias de la salud. Se programó un software mediante el entorno de desarrollo integrado Embarcadero Delphi, el cual utilizó Object Pascal como lenguaje de programación. Para el proceso de elaboración del sistema informático se empleó la metodología SCRUM, con una la lista de productos que consiste en el conjunto de requerimientos funcionales y no funcionales que debe satisfacer la aplicación. Se logró el desarrollo del software MULTI-CONTROL-INTERNO, con una ventana principal que incluye un menú contextual para acceder a todas las ventanas de la aplicación e introducir los valores de las variables necesarias para calcular los indicadores y gráficos dinámicos de cada una de las perspectivas del cuadro de mando integral, y se obtuvo el diseño de las estrategias para la mejora del sistema sanitario según la gestión de la información en el hospital a través de los índices de cumplimiento de los objetivos, la eficacia, la eficiencia y los componentes del control interno. El sistema informativo en entidades hospitalarias cubanas es hoy un acápite pendiente por la dinámica del entorno sanitario(AU)

The purpose of the study was to develop an information system for the automation of the integrated control panel as an internal control tool in hospitals, thus contributing to health information management. A software application was programmed in the Embarcadero Delphi integrated development environment, using Object Pascal as programming language. Development of the information system was based on SCRUM methodology, with a list of products consisting in the set of functional and non-functional requirements to be met by the application. The software Multi-internal-control was thus developed, with a main window which includes a context menu to access all the windows in the application and enter the values of variables required to estimate the dynamic charts and indicators of each of the perspectives on the integrated control panel, obtaining the design of strategies for the improvement of the healthcare system according to the information management procedure in place at the hospital, through goal achievement indices, efficacy, efficiency and internal control components. The information system at Cuban hospital institutions is still a pending item due to the dynamics of the healthcare environment(AU)

Comparative performances of seven quantitative Reverse-Transcription Polymerase Chain Reaction assays (RT-qPCR) for detecting SARS-CoV-2 infection in samples from individuals suspected of COVID-19 in São Paulo, Brazil.

Introduction: Brazil is the second largest country with COVID-19 positive cases worldwide. Due to the potent spread of the virus and the scarcity of kits and supplies, the Brazilian Ministry of Health has granted authorization for the use of kits available during this emergency, without an accurate evaluation of their performance. This study compared the performance and cost-effectiveness of seven molecular assays/kits available in São Paulo, Brazil, for SARS-CoV-2 diagnosis. Materials and methods: A total of 205 nasopharyngeal/oropharyngeal samples from suspected cases of COVID-19, were tested using the following assays: (i) GeneFinder COVID-19 plus RealAmp kit; (ii) 2019-nCoV RNA PCR-Fluorescence Probing, Da An Gene Co.; (iii) in-house RT-qPCR SARS-CoV-2 IAL; (iv) 2019-nCoV kit, IDT; (v) molecular SARS-CoV-2 (E) kit, Bio-Manguinhos; (vi) Allplex 2019-nCoV modified Assay, Seegene Inc, and (vii) Biomol one-step COVID-19 kit, IBMP. The criteria for determining a SARS-CoV-2 true positive result included the cycle threshold cut-off values, the characteristics of exponential/linear curves, the gene target diversity, and a positive result in at least two assays. Results: The overall sensitivity of the assays listed were GeneFinder 83.6%, Da An Gene 100.0%, IAL 90.4%, IDT 94.6%, Bio-Manguinhos 87.7%, Allplex 97.3%, and IBMP 87.7%. The minor sensitive gene target was RdRP. Although all assays had a Cohen's Kappa index ≥0.893, the best tests used multiplex assays identifying N-gene and/or E-gene targets. Conclusion: All assays tested accurate for diagnosis, but considering cost-effectiveness (cost, time consumption, number of samples tested, and performance), the in-house IAL assay was ideal for COVID-19 diagnosis in São Paulo, Brazil.

Proceso de desafío a la COVID-19 apoyado en el Ambiente de Control / The process to cope with COVID-19 supported by the control environment

RESUMEN Introducción: la falta de referencias sobre crisis semejantes a la Covid-19 hace difícil la predicción de un futuro inmediato. Como es lógico, los efectos presentes son fácilmente documentables, pero aquellos que dejarán huella en los distintos actores a medio y a largo plazo resultan más sujetos a debate. Objetivos: evidenciar el desempeño que tiene el ambiente de control como base de control interno, en el enfrentamiento a la Covid-19. Métodos: se diseñó el sistema de enfrentamiento a la COVID-19, al evidenciar el papel de los elementos del ambiente de control y su relación con el proceso de capital humano sanitario. Resultados: se tiene el mapa de proceso del sistema de enfrentamiento a la COVID-19 donde el control interno se materializa de manera transversal y se demuestra la importancia de los elementos del ambiente de control como la planificación, los valores éticos, idoneidad demostrada, estructura organizativa, las políticas y prácticas de recursos humanos y su relación con el desempeño de la gestión del capital humano sanitario. Conclusiones: la importancia reflejada en el desafío de la pandemia de los elementos del ambiente de control, como base del proceso transversal "control interno" del sistema de desafío a la COVID-19 y la importancia de la relación con los procesos de gestión de los elementos del capital humano sanitario; permitieron establecer una estrategia de mejora basadas en un plan de acción.

ABSTRACT Introduction: the lack of references to crises similar to COVID-19 in the past makes it difficult to predict what may happen in the immediate future. Logically, the present effects of this pandemic are without doubt documented, but those that will leave their mark on the different protagonists at medium and long-term are more subject to debate. Objectives: to demonstrate the role of the control environment as a basis for the internal control in coping with COVID-19. Methods: the strategy to cope with COVID-19 is designed; the role of the elements that are involved in the control environment and the relationship with the process of human-health capital is evidenced. Results: the process map to develop the strategy to cope with COVID-19 where the internal control is materialized in a cross-sectional approach, as the significance of the elements involved in the control environment such as: planning, ethical values, proven competences, organizational structure in addition to the human resources policies, and the practices, as well as the relationships with the actions established to direct the human-health capital. Conclusions: the impact reflected to cope with this pandemic along with the elements of the control environment, as the basis for the cross-sectional process (internal control) designed for the strategy to cope with COVID-19, as well as the importance of the processes and the relationships to direct the elements involved in human-health capital, allow establishing a strategy of improvement based on an action plan.

Detection of HEV in naturally infected swine from central Argentina by an optimized HEV/MS2 duplex RT-qPCR.

Hepatitis E virus (HEV) is currently considered as a global health concern due to the recognition of its zoonotic transmission to humans, mainly from swine, and its association with the development of severe cases of hepatitis in human risk populations. The lack of updated data on HEV state of infection in swineherds of Argentina, and the necessity of robust technologies for its detection in complex biological samples, positions HEV as an emerging issue in public health. Here, we have optimized a RT-qPCR with internal control for a more precise and accurate HEV RNA detection in swine stool samples. We implemented this optimized molecular tool to analyse the current epidemiological scenario of HEV infection in swine from the core region of commercial activity of Argentina. A total of 135 stool samples were collected from 16 different farms and tested for HEV presence, resulting in 11 positive cases (8.1%). Phylogenetic analysis demonstrated that all of them correspond to HEV genotype 3 and that different subtypes circulate in the region. Moreover, two of the detected strains presented a high nucleotide similarity with a previously identified isolate from human sewage discharges, suggesting the zoonotic transmission of HEV to humans. Collectively, this work provides a better understanding of HEV epidemiology in Argentina while contributes to the improvement of HEV detection technologies.

A falta de trabalho institucional e mudanças organizacionais incompletas em municípios brasileiros / La falta de trabajo institucional y cambios organizacionales incompletos en municipios brasileños / Lack of institutional work and organizational change failure in Brazilian local governments

Resumo Este artigo propõe um modelo para explicar falhas na adoção compulsória de novas práticas no ciclo de gestão financeira em municípios. Empiricamente, aplica-se o modelo à adoção de sistemas de controle interno (SCI) em municípios brasileiros. As evidências da análise qualitativa comparada (qualitative comparative analysis - QCA) em sete prefeituras mostram que, apesar de recursos humanos e de sistemas serem condição necessária, eles não são suficientes para a implementação das práticas de controle interno. O chamado capital institucional é uma condição sine qua non para a adoção de novas práticas de administração e controle financeiro em governos locais no Brasil. A adoção dessas reformas depende da atuação de uma rede de "atores com poder" que realizam trabalho institucional em prol das mudanças.

Resumen Este artículo propone un modelo para explicar fallas en la adopción obligatoria de nuevas prácticas en el ciclo de gestión financiera en municipios. Empíricamente, se aplica el modelo a la adopción de los sistemas de control interno en municipios brasileños. Las evidencias del análisis comparativo cualitativo (qualitative comparative analysis - QCA) en siete municipalidades demuestran que la existencia de recursos humanos y de sistemas son una condición necesaria, pero no suficiente para la implementación de las prácticas del control interno. El capital institucional es una condición sine qua non para la adopción de nuevas prácticas de gestión y control financiero en gobiernos locales en Brasil. La adopción de esas reformas depende del apoyo de varios "actores con poder" que realizan trabajo institucional en pro de las reformas.

Abstract This article proposes a theoretical framework to explain the failure of the compulsory adoption of new practices in the financial management cycle in local governments. The empirical analysis applies the framework to the control systems implementation in Brazilian municipalities. The findings of a qualitative comparative analysis applied to seven local governments show that despite human capabilities and information systems being a necessary condition, they are insufficient to deeply implement such internal control practices. Institutional capital is a condition sine qua non for the adoption of new practices on financial management and control in Brazilian local governments. The adoption of such reforms depends on an active network of powerful actors involved in institutional work supporting the changes.

Integración de los enfoques de gestión documental y gestión de riesgos para el tratamiento de la información como evidencia de actos y transacciones organizacionales / Integration of the approaches of documentary management and risk management for the treatment of the information as evidence of acts and organizational transactions

En el presente artículo se exploran los nexos entre gestión documental y gestión de riesgos. Para esto se analiza cómo la gestión documental ha evolucionado en las últimas décadas hasta enfocarse en los procesos de captura y mantenimiento de evidencias de actos y transacciones de negocios. Se muestra cómo la literatura especializada exploró dicha relación e identificó que los documentos son tanto fuentes de información para la identificación de riesgos, como objetos de riesgos en sí mismos. Se concluye que los sistemas de gestión documental ayudan a las organizaciones a gestionar la incertidumbre en relación con el fracaso en la creación y control de documentos de calidad, por el impacto negativo que esto tiene en la capacidad de la organización para lograr sus objetivos. En este sentido se considera que un sistema de gestión documental es un sistema de gestión de riesgos, en el que es esencial la determinación de requisitos de gestión documental para la identificación y la mitigación de riesgos organizacionales derivados de la información, como evidencia de actos y transacciones de negocios(AU)

In this article the links between records management and risk management are explored. It is exposed how records management has evolved in recent decades to focus on the processes of capture and maintenance of acts evidence and business transactions. It shows how the specialized literature explored this relationship and identified that documents are both information sources for risks identification, and objects of risks in themselves. It is concluded that Records Management Systems help organizations to manage the effect of uncertainty in relation to the failure in the creation and control of quality documents, due to the negative impact that this has on the organization's capacity to achieve its objectives. In that sense a Records Management System is considered to be a Risk Management system, where it is essential the determination of records management requirements for the identification and mitigation of organizational risks derived from information as acts and business transactions evidences(AU)

Integración de los enfoques de gestión documental y gestión de riesgos para el tratamiento de la información como evidencia de actos y transacciones organizacionales / Integration of the approaches of documentary management and risk management for the treatment of the information as evidence of acts and organizational transactions

En el presente artículo se exploran los nexos entre gestión documental y gestión de riesgos. Para esto se analiza cómo la gestión documental ha evolucionado en las últimas décadas hasta enfocarse en los procesos de captura y mantenimiento de evidencias de actos y transacciones de negocios. Se muestra cómo la literatura especializada exploró dicha relación e identificó que los documentos son tanto fuentes de información para la identificación de riesgos, como objetos de riesgos en sí mismos. Se concluye que los sistemas de gestión documental ayudan a las organizaciones a gestionar la incertidumbre en relación con el fracaso en la creación y control de documentos de calidad, por el impacto negativo que esto tiene en la capacidad de la organización para lograr sus objetivos. En este sentido se considera que un sistema de gestión documental es un sistema de gestión de riesgos, en el que es esencial la determinación de requisitos de gestión documental para la identificación y la mitigación de riesgos organizacionales derivados de la información, como evidencia de actos y transacciones de negocios(AU)

In this article the links between records management and risk management are explored. It is exposed how records management has evolved in recent decades to focus on the processes of capture and maintenance of acts evidence and business transactions. It shows how the specialized literature explored this relationship and identified that documents are both information sources for risks identification, and objects of risks in themselves. It is concluded that Records Management Systems help organizations to manage the effect of uncertainty in relation to the failure in the creation and control of quality documents, due to the negative impact that this has on the organization's capacity to achieve its objectives. In that sense a Records Management System is considered to be a Risk Management system, where it is essential the determination of records management requirements for the identification and mitigation of organizational risks derived from information as acts and business transactions evidences(AU)

Adenovirus and rotavirus recovery from a treated effluent through an optimized skimmed-milk flocculation method.

Sewage treatment may be insufficient for the complete removal of enteric viruses, such as human adenoviruses (HAdV) and group A rotavirus (RVA). The differences in the efficiency of the treatment methodologies used may interfere with the detection of these viruses. The objective of this study was to optimize a skimmed-milk flocculation technique for the recovery of HAdV and RVA in the samples of treated effluent. The treated effluent collected at the wastewater treatment plant (WWTP) was processed via four protocols including modifications in the initial centrifugation step and the final concentration of skimmed-milk. The viral load and recovery rate were determined by quantitative PCR TaqMan® System. The highest recovery rates of HAdV, RVA, and bacteriophage PP7 (internal control process) were obtained when the concentration of skimmed-milk was doubled and no centrifugation step was used for the sample clarification. The optimized protocol was assessed in a field study conducted with 24 treated effluent samples collected bi-monthly during 2015. HAdV and RVA were detected in 50.0% (12/24) and 33.3% (08/24) of the samples tested, respectively, throughout the year, without seasonal variation (p > 0.05). This study corroborates the use of the organic flocculation method for virus recovery in environmental samples with the adaptation of the protocols to different aquatic matrices.

Contribución a la implantación del control interno a través de sus variables activas en una entidad hospitalaria / Contribution to the implantation of internal control through its active variables in a hospital entity

Introducción: en el nuevo milenio las entidades de la salud pública necesitan poseerherramientas que le permitan desempeñar correctamente sus funciones dentro de lasociedad. En Cuba los hospitales son unidades presupuestadas por lo que resultaimprescindible un eficiente control de sus medios y recursos por el costo que estosrepresentan para el país, de ahí que un eficiente sistema de control interno es vitalpara el logro de sus metas.Objetivo: gestionar el control interno a través de sus variables activas paradiagnosticar sus debilidades.Materiales y Métodos: se manipularon métodos de investigación pertinentes como elanálisis prospectivo y la modelación matemática a través de indicadores.Resultados: se obtuvo un índice de gestión del control interno que calificó al hospitalcon un medio control, así como acciones para su implantación. Quedaron establecidoslos principales valores éticos de los trabajadores en una entidad hospitalaria.Conclusiones: se demostró la pertinencia del análisis prospectivo en la contribuciónde la implantación del control interno. Se determinó como variables activas lasreferentes al ambiente de control. En su diagnóstico la entidad presentó un controlmedio (AU).

Introduction: in the new millennium, public health institutions need tools allowingthem to correctly perform their functions in the society. Hospitals in Cuba are budgetedentities, resulting unavoidable the efficient control of their means and resources due tothe high cost they represent for the country. Therefore, an efficient system of internalcontrol is vital to achieve their goals.Objective: to manage internal control through its active variables to diagnose itsweaknesses.Materials and Methods: appropriate research methods such as prospective analysisand mathematical modeling through indicators were handled.Results: an internal control management index was obtained, as well as actions for itsimplementation. The internal control was qualified as average. The contribution of theresearch included the establishment of the main ethical values of workers in a hospitalinstitution.Conclusions: the relevance of the prospective analysis as a contribution to theimplementation of internal control was acknowledged. Active variables were consideredthose related with the control environment variable. In the diagnosis the entity showedan average control (AU).

Contribución a la implantación del control interno a través de sus variables activas en una entidad hospitalaria / Contribution to the implantation of internal control through its active variables in a hospital entity

Introducción: en el nuevo milenio las entidades de la salud pública necesitan poseer herramientas que le permitan desempeñar correctamente sus funciones dentro de la sociedad. En Cuba los hospitales son unidades presupuestadas por lo que resulta imprescindible un eficiente control de sus medios y recursos por el costo que estos representan para el país, de ahí que un eficiente sistema de control interno es vital para el logro de sus metas. Objetivo: gestionar el control interno a través de sus variables activas para diagnosticar sus debilidades. Materiales y Métodos: se manipularon métodos de investigación pertinentes como el análisis prospectivo y la modelación matemática a través de indicadores. Resultados: se obtuvo un índice de gestión del control interno que calificó al hospital con un medio control, así como acciones para su implantación. Quedaron establecidos los principales valores éticos de los trabajadores en una entidad hospitalaria. Conclusiones: se demostró la pertinencia del análisis prospectivo en la contribución de la implantación del control interno. Se determinó como variables activas las referentes al ambiente de control. En su diagnóstico la entidad presentó un control medio (AU).

Introduction: in the new millennium, public health institutions need tools allowing them to correctly perform their functions in the society. Hospitals in Cuba are budgeted entities, resulting unavoidable the efficient control of their means and resources due to the high cost they represent for the country. Therefore, an efficient system of internal control is vital to achieve their goals. Objective: to manage internal control through its active variables to diagnose its weaknesses. Materials and Methods: appropriate research methods such as prospective analysis and mathematical modeling through indicators were handled. Results: an internal control management index was obtained, as well as actions for its implementation. The internal control was qualified as average. The contribution of the research included the establishment of the main ethical values of workers in a hospital institution. Conclusions: the relevance of the prospective analysis as a contribution to the implementation of internal control was acknowledged. Active variables were considered those related with the control environment variable. In the diagnosis the entity showed an average control (AU).

Internal control for real-time polymerase chain reaction based on MS2 bacteriophage for RNA viruses diagnostics

BACKGROUND Real-time reverse transcription polymerase chain reaction (RT-PCR) is routinely used to detect viral infections. In Brazil, it is mandatory the use of nucleic acid tests to detect hepatitis C virus (HCV), hepatitis B virus and human immunodeficiency virus in blood banks because of the immunological window. The use of an internal control (IC) is necessary to differentiate the true negative results from those consequent from a failure in some step of the nucleic acid test. OBJECTIVES The aim of this study was the construction of virus-modified particles, based on MS2 bacteriophage, to be used as IC for the diagnosis of RNA viruses. METHODS The MS2 genome was cloned into the pET47b(+) plasmid, generating pET47b(+)-MS2. MS2-like particles were produced through the synthesis of MS2 RNA genome by T7 RNA polymerase. These particles were used as non-competitive IC in assays for RNA virus diagnostics. In addition, a competitive control for HCV diagnosis was developed by cloning a mutated HCV sequence into the MS2 replicase gene of pET47b(+)-MS2, which produces a non-propagating MS2 particle. The utility of MS2-like particles as IC was evaluated in a one-step format multiplex real-time RT-PCR for HCV detection. FINDINGS We demonstrated that both competitive and non-competitive IC could be successfully used to monitor the HCV amplification performance, including the extraction, reverse transcription, amplification and detection steps, without compromising the detection of samples with low target concentrations. In conclusion, MS2-like particles generated by this strategy proved to be useful IC for RNA virus diagnosis, with advantage that they are produced by a low cost protocol. An attractive feature of this system is that it allows the construction of a multicontrol by the insertion of sequences from more than one pathogen, increasing its applicability for diagnosing different RNA viruses.

Diagnóstico estadístico del control interno en una institución hospitalaria / Statistical diagnosis of the internal control in a hospital institution

Introducción: Las organizaciones empresariales, específicamente las relacionadas con la salud pública, por ser unidades presupuestadas, están llamadas a trabajar con el objetivo de perfeccionar su sistema de control interno, siendo determinante para la mejora de sus resultados, así como para el incremento de la eficiencia y la satisfacción a la población. Objetivo: Diagnosticar la gestión del control interno en una entidad hospitalaria del territorio holguinero en Cuba, para contribuir a su mejora. Material y Métodos: Aplicación del Método General de Solución de Problemas apoyado en análisis estadísticos con la ayuda de softwares profesionales. Resultados: La identificación de deficiencias existentes en la aplicación de las normas correspondientes a los componentes del sistema de control interno, además de la elaboración de una estrategia encaminada a la mejora de este sistema en la entidad hospitalaria. Conclusiones: Se identificó un conjunto de acciones estratégicas por conglomerados de áreas en el hospital, que contribuyen a la solución de las deficiencias encontradas, priorizando aquellas relacionadas con la integridad y valores éticos, estructura organizativa, tecnología de la información y las comunicaciones, contenido, calidad y responsabilidad y rendición de cuenta(AU)

Introduction: Corporate organizations, specifically those related with public health, as budgeted units, are called to work with the goal of improve their internal control system, being determinant for the betterment of their results, as well as for the increase of the efficiency and satisfaction of the population. Objective: To diagnose the internal control management in a hospital entity belonging to Holguins province, Cuba, with the purpose of contribute to its improvement. Material and Methods: Application of the Solving Problems General Method supported by statistical analysis with the help of professional software. Results: The identification of existing deficiencies in the application of the rules to the components of the internal control system, and also the preparation of a strategy aimed to the improvement of this system in the hospital. Conclusions: A set of strategic actions was identified by areas clusters in the hospital, which contribute to solve the deficiencies found, prioritizing those related to integrity and ethical values, organizational structure, information and communications technology, content, quality, responsibility and accountability(AU)

Diagnóstico estadístico del control interno en una institución hospitalaria / Statistical diagnosis of the internal control in a hospital institutioni:en

Introducción: Las organizaciones empresariales, específicamente las relacionadas con la salud pública, por ser unidades presupuestadas, están llamadas a trabajar con el objetivo de perfeccionar su sistema de control interno, siendo determinante para la mejora de sus resultados, así como para el incremento de la eficiencia y la satisfacción a la población. Objetivo: Diagnosticar la gestión del control interno en una entidad hospitalaria del territorio holguinero en Cuba, para contribuir a su mejora. Material y Métodos: Aplicación del Método General de Solución de Problemas apoyado en análisis estadísticos con la ayuda de softwares profesionales. Resultados: La identificación de deficiencias existentes en la aplicación de las normas correspondientes a los componentes del sistema de control interno, además de la elaboración de una estrategia encaminada a la mejora de este sistema en la entidad hospitalaria. Conclusiones: Se identificó un conjunto de acciones estratégicas por conglomerados de áreas en el hospital, que contribuyen a la solución de las deficiencias encontradas, priorizando aquellas relacionadas con la integridad y valores éticos, estructura organizativa, tecnología de la información y las comunicaciones, contenido, calidad y responsabilidad y rendición de cuenta(AU)

Introduction: Corporate organizations, specifically those related with public health, as budgeted units, are called to work with the goal of improve their internal control system, being determinant for the betterment of their results, as well as for the increase of the efficiency and satisfaction of the population. Objective: To diagnose the internal control management in a hospital entity belonging to Holguin’s province, Cuba, with the purpose of contribute to its improvement. Material and Methods: Application of the Solving Problems General Method supported by statistical analysis with the help of professional software. Results: The identification of existing deficiencies in the application of the rules to the components of the internal control system, and also the preparation of a strategy aimed to the improvement of this system in the hospital. Conclusions: A set of strategic actions was identified by areas; clusters in the hospital, which contribute to solve the deficiencies found, prioritizing those related to integrity and ethical values, organizational structure, information and communications technology, content, quality, responsibility and accountabilit(AU.

Desempeño del kit ELISA chagas IICS V.1 para el diagnóstico de la enfermedad de chagas / ELISA chagas test IICS V.1 evaluation for the diagnosis of chagas disease

En Paraguay, el tamizaje serológico para la enfermedad de Chagas en bancos de sangre es necesario, por lo cual es importante un método diagnóstico con alta sensibilidad. El ELISA Chagas test IICS V.1 es un ELISA indirecto sensibilizados con antígeno soluble de epimastigote de T.cruzide la cepa Ypsilon. El objetivo del presente trabajo fue evaluar el desempeño del ELISA Chagas test IICS V.1 en comparación con kits comerciales, ademásanalizar los resultados de la evaluación externa e interna de calidad del kit. En este estudio observacional de prueba diagnóstica se analizaron 56 muestras de suerospositivos y negativos para antígenos de Trypanosoma cruzi, testados por el ELISA BiosChile, obteniéndose una concordancia excelente entre el ELISA Chagas test IICS V.1y los kits comerciales: Chagatest ELISA-Wiener, con Índice kappa: 0,89 IC de 95% (0,76-1) y Test ELISA para Chagas III-Grupo BiosChile con Índice kappa: 0,92 IC 95% (0,82-1).En la evaluación externa de calidad realizada por la Fundação Pró-Sangue/Hemocentro de São Paulo, Brasil en el periodo 2001 al 2012 se analizaron 450 muestras: 372 negativas y 78 positivas para T. cruzi, obteniéndose en dicha evaluación la calificación "A" que indica ausencia de falsos positivos y negativos. Además, en el mismo periodo los valores del control interno se encontraron dentro del rango permitido de ±2DS. Los resultados obtenidos en el estudio demuestran la alta calidad de este test de producción nacional, que sumado al bajo costo del mismo, pueden ser utilizados en trabajos de campo, donde no necesita de instrumentación y las lecturas pueden realizarse a simple vista, constituyendo una herramienta válida y útil para el apoyo al diagnóstico de la enfermedad de Chagas.

In Paraguay, the serological screening for Chagas disease is mandatory in pregnant women and blood banks, therefore a high sensitivity diagnostic method is required. The aimof this study was to evaluate the ELISA Chagas test IICS V.1 by comparison with commercial kits and to analyze the external and internal quality evaluation results. In this descriptive observational study, 56 seropositive and seronegative to Trypanosoma cruzisamples were analyzed, obtaining an excellent concordance between the ELISA Chagas test IICS V.1 and these commercial kits: Chagatest ELISA-Wiener, Argentina (kappa index:0.89) and Test ELISA Chagas III-Grupo Bios, Chile (kappa index: 0.92).In the externalquality assessment carried out by the Fundação Pró-Sangue /Blood Center of São Paulo,Brazil in the period 2001 to 2012, 450 samples were analyzed: 372 seronegative and 78seropositive for T. cruzi. In this evaluation, an “A” score was obtained indicating theabsence of false positives and negatives. Additionally, in the same period of time theinternal control values were within the accepted range of ± 2SD, with a confidence intervalof 95%. The results obtained in the present study demonstrate the high quality of this locally produced test which added to its low cost, making it a valid and useful tool tosupport the diagnosis of Chagas disease.

Molecular organization of the 5S rDNA gene type II in elasmobranchs.

The 5S rDNA gene is a non-coding RNA that can be found in 2 copies (type I and type II) in bony and cartilaginous fish. Previous studies have pointed out that type II gene is a paralog derived from type I. We analyzed the molecular organization of 5S rDNA type II in elasmobranchs. Although the structure of the 5S rDNA is supposed to be highly conserved, our results show that the secondary structure in this group possesses some variability and is different than the consensus secondary structure. One of these differences in Selachii is an internal loop at nucleotides 7 and 112. These mutations observed in the transcribed region suggest an independent origin of the gene among Batoids and Selachii. All promoters were highly conserved with the exception of BoxA, possibly due to its affinity to polymerase III. This latter enzyme recognizes a dT4 sequence as stop signal, however in Rajiformes this signal was doubled in length to dT8. This could be an adaptation toward a higher efficiency in the termination process. Our results suggest that there is no TATA box in elasmobranchs in the NTS region. We also provide some evidence suggesting that the complexity of the microsatellites present in the NTS region play an important role in the 5S rRNA gene since it is significantly correlated with the length of the NTS.