Retorno das atividades presenciais nos cursos de Odontologia brasileiros na pandemia de COVID-19: comparação entre instituições públicas e privadas / Retorno de las actividades presenciales en los cursos de Odontología brasileños durante la pandemia de COVID-19: comparación entre instituciones públicas y privadas / Return of on-site activities in Brazilian Dentistry courses during the COVID-19 pandemic: comparison between public and private institutions

Trata-se de estudo quanti-qualitativo que analisa o retorno das atividades presenciais nos cursos de Odontologia brasileiros, durante a pandemia de COVID-19, e as dificuldades enfrentadas, comparando instituições públicas e privadas. Um formulário on-line com questões abertas e fechadas foi encaminhado por e-mail aos representantes dos cursos de Odontologia, de março a junho de 2021. Foram incluídos os cursos cadastrados no sitee-MEC iniciados até 2017. A análise quantitativa utilizou os testes qui-quadrado, exato de Fisher e t de Student(p<0,05); uma questão aberta foi submetida à análise temática de conteúdo. Dos 329 cursos elegíveis, foram respondidos 83 formulários (21 públicos e 62 privados). Os cursos de instituições públicas apresentaram menor frequência de retorno das atividades presenciais até a data da coleta (p=0,038), inclusive com maior proporção de suspensão das atividades clínicas e laboratoriais (p≤0,001), mas sem diferença para aulas teóricas remotas (p>0,05). Os cursos privados demonstraram ter maior disponibilidade de recursos para o retorno presencial, tais como: estrutura, funcionários e docentes (p<0,001). Apesar das normas de biossegurança constituírem um desafio comum, as principais dificuldades relatadas nas instituições privadas diante do retorno das atividades presenciais foram a modulação ou escalonamento das turmas e ambientes de aula, controle do fluxo de pessoas e implantação de protocolos. Nas públicas, destacam-se dificuldades relacionadas à adequação da estrutura e aquisição de materiais. Conclui-se que a maioria dos cursos de Odontologia havia retomado às aulas no início de 2021, mas as instituições privadas apresentaram maior proporção de retorno às atividades laboratoriais e clínicas presenciais (AU).

Se trata de un estudio cuantitativo y cualitativo que analiza el retorno de las actividades presenciales en las carreras de Odontología brasileñas, durante la pandemia de COVID-19, y las dificultades enfrentadas, comparando instituciones públicas y privadas. Se envió por correo electrónico un formulario en línea con preguntas abiertas y cerradas a los representantes de los cursos de Odontología, de marzo a junio de 2021. Se incluyeron los cursos registrados en el sitio web de e-MEC que iniciaron hasta el año 2017. El análisis cuantitativo utilizó las pruebas chi-cuadrado, Fisher exacta y t de Student (p<0,05); se sometió una pregunta abierta al análisis de contenido temático. De los 329 cursos elegibles, se completaron 83 formularios (21 públicos y 62 privados). Los cursos de instituciones públicas mostraron una menor frecuencia de retorno a actividades presenciales hasta la fecha de cobro (p=0,038), incluyendo una mayor proporción de suspensión de actividades clínicas y de laboratorio (p≤0,001), pero sin diferencia para clases teóricas remotas (p >0.05). Los cursos privados demostraron mayor disponibilidad de recursos para el retorno presencial, tales como: estructura, personal y docentes (p<0,001). Si bien los estándares de bioseguridad constituyen un desafío común, las principales dificultades reportadas en las instituciones privadas ante el regreso de las actividades presenciales fueron modular o escalonar clases y ambientes de aula, controlar el flujo de personas e implementar protocolos. En las públicas destacan dificultades relacionadas con la adecuación de la estructura y adquisición de materiales. Se concluye que la mayoría de las carreras de Odontología habían retomado clases a inicios de 2021, pero las instituciones privadas tuvieron una mayor proporción de retorno a las actividades presenciales de laboratorio y clínicas (AU).

This is a quantitative-qualitative study analyzing the return of on-site activities in Brazilian dentistry undergraduate courses during the COVID-19 pandemic and the difficulties faced, comparing public and private institutions. An online form with open and multiple-choice questions was sent via e-mail to the representatives of dentistry courses from March to June 2021. The courses included were those registered on the e-MEC webpage that had started up to 2017. The quantitative analysis employed the chi-square, the Fisher exact, and the T student tests (p<0.05); the open question was subjected to thematic content analysis. Out of the 329 eligible courses, 83 forms were answered and returned (21 public and 62 private). Public institution courses showed lower frequency of return to on-site activities up tothe data collection (p=0.038), and presented higher proportion of suspension of clinical and laboratory activities (p≤0.001), but no difference regarding remote theoretical lessons (p>0.05). Private courses showed higher availability of resources supporting the return to on-site activities, namely, structure, workers, and professors (p<0.001). Although biosafety norms presented a common challenge, the main difficulties reported in private institutions related to the return to on-site activities were the modulation and schedule of the classes and lesson environments, controlling the flow of people, and the implementation of protocols. Public institutions highlighted difficulties related to adjustment of the structure and material acquisition. The results showed that most dentistry courses had returned to on-site lessons in the early 2021, but private institutions reported higher proportion of return to on-site laboratory and clinical activities (AU).

Evaluación de riesgo biológico en el control de calidad de vacunas virales / Biological risk evaluation in the quality control of viral vaccines

Las medidas de bioseguridad son el conjunto de conductas mínimas a ser adoptadas, a fin de reducir o eliminar los riesgos para el personal, la comunidad y el medio ambiente. Los laboratorios veterinarios manipulan materiales biológicos que pueden suponer riesgos biológicos tanto para los animales como para el hombre, por lo que los profesionales de estos laboratorios están expuestos a una variedad de riesgos relacionados con su trabajo que pueden afectar su salud. El objetivo de este trabajo fue evaluar el riesgo en el control de calidad de las vacunas virales mediante el uso del método BIOGAVAL, una forma cómoda y fiable de evaluar el riesgo de exposición a agentes biológicos. El estudio se realizó en la Unidad Empresarial de Base Control de la Calidad de la Empresa Productora de Vacunas Virales y Bacterianas el cual pertenece a LABIOFAM. La muestra de estudio estuvo conformada por 18 trabajadores, distribuidos en tres áreas. En los resultados obtenidos para valores superiores a 12 del nivel de acción biológica se requiere la adopción de medidas preventivas para reducir la exposición en el caso de Avulavirus, Pestivirus y Coronavirus, mientras que para Alphavirus se requieren acciones correctoras inmediatas ya que representa una situación de riesgo intolerable(AU)

Biosafety measures are the set of minimum behaviors to be adopted, in order to reduce or eliminate risks to personnel, the community and the environment. Veterinary laboratories handle biological materials that can pose biological risks for both animals and humans, so that professionals in these laboratories are exposed to a variety of risks to their health related to their work. The objective of this work was to evaluate the risk in the quality control of viral vaccines through the use of BIOGAVAL method, a convenient and reliable way to assess the risk of exposure to biological agents. The study was carried out in the Base Business Unit Quality Control of the Production Company of Viral and Bacterial Vaccines which belongs to LABIOFAM. The study sample consisted was 18 workers, dispersed in three areas. For values above 12 of the biological action level, preventive measures are required to reduce exposure to Avulavirus, Pestivirus and Coronavirus, while for Alphavirus immediate corrective measures actions are required as it represents an intolerable risk situation(AU)

Directrices de laboratorio para la detección y el diagnóstico de la infección por el virus de la viruela del mono / Laboratory Guidelines for the Detection and Diagnosis of Monkeypox Virus Infection

Este documento está basado en la guía provisional de la Organización Mundial de la Salud sobre las pruebas de laboratorio para el virus de la viruela del mono, 23 de mayo de 2022, y tiene por objeto proporcionar orientación a los Laboratorios Nacionales de Referencia sobre la detección del virus de la viruela del mono

This document is based on World Health Organization interim guidance on Laboratory testing for monkeypox virus, 23 May 2022, and is intended to provide guidance to National Reference Laboratories on monkeypox virus laboratory detection

Preclinical coronavirus studies and pathology: Challenges of the high-containment laboratory.

The COVID-19 pandemic has highlighted the critical role that animal models play in elucidating the pathogenesis of emerging diseases and rapidly analyzing potential medical countermeasures. Relevant pathologic outcomes are paramount in evaluating preclinical models and therapeutic outcomes and require careful advance planning. While there are numerous guidelines for attaining high-quality pathology specimens in routine animal studies, preclinical studies using coronaviruses are often conducted under biosafety level-3 (BSL3) conditions, which pose unique challenges and technical limitations. In such settings, rather than foregoing pathologic outcomes because of the inherent constraints of high-containment laboratory protocols, modifications can be made to conventional best practices of specimen collection. Particularly for those unfamiliar with working in a high-containment laboratory, the authors describe the logistics of conducting such work, focusing on animal experiments in BSL3 conditions. To promote scientific rigor and reproducibility and maximize the value of animal use, the authors provide specific points to be considered before, during, and following a high-containment animal study. The authors provide procedural modifications for attaining good quality pathologic assessment of the mouse lung, central nervous system, and blood specimens under high-containment conditions while being conscientious to maximize animal use for other concurrent assays.

Development of a Single-Cycle Infectious SARS-CoV-2 Virus Replicon Particle System for Use in Biosafety Level 2 Laboratories.

Research activities with infectious severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are currently permitted only under biosafety level 3 (BSL3) containment. Here, we report the development of a single-cycle infectious SARS-CoV-2 virus replicon particle (VRP) system with a luciferase and green fluorescent protein (GFP) dual reporter that can be safely handled in BSL2 laboratories to study SARS-CoV-2 biology. The spike (S) gene of SARS-CoV-2 encodes the envelope glycoprotein, which is essential for mediating infection of new host cells. Through deletion and replacement of this essential S gene with a luciferase and GFP dual reporter, we have generated a conditional SARS-CoV-2 mutant (ΔS-VRP) that produces infectious particles only in cells expressing a viral envelope glycoprotein of choice. Interestingly, we observed more efficient production of infectious particles in cells expressing vesicular stomatitis virus (VSV) glycoprotein G [ΔS-VRP(G)] than in cells expressing other viral glycoproteins, including S. We confirmed that infection from ΔS-VRP(G) is limited to a single round and can be neutralized by anti-VSV serum. In our studies with ΔS-VRP(G), we observed robust expression of both luciferase and GFP reporters in various human and murine cell types, demonstrating that a broad variety of cells can support intracellular replication of SARS-CoV-2. In addition, treatment of ΔS-VRP(G)-infected cells with either of the anti-CoV drugs remdesivir (nucleoside analog) and GC376 (CoV 3CL protease inhibitor) resulted in a robust decrease in both luciferase and GFP expression in a drug dose- and cell-type-dependent manner. Taken together, our findings show that we have developed a single-cycle infectious SARS-CoV-2 VRP system that serves as a versatile platform to study SARS-CoV-2 intracellular biology and to perform high-throughput screening of antiviral drugs under BSL2 containment. IMPORTANCE Due to the highly contagious nature of SARS-CoV-2 and the lack of immunity in the human population, research on SARS-CoV-2 has been restricted to biosafety level 3 laboratories. This has greatly limited participation of the broader scientific community in SARS-CoV-2 research and thus has hindered the development of vaccines and antiviral drugs. By deleting the essential spike gene in the viral genome, we have developed a conditional mutant of SARS-CoV-2 with luciferase and fluorescent reporters, which can be safely used under biosafety level 2 conditions. Our single-cycle infectious SARS-CoV-2 virus replicon system can serve as a versatile platform to study SARS-CoV-2 intracellular biology and to perform high-throughput screening of antiviral drugs under BSL2 containment.

Manual de biossegurança e bioprotecção 2ª edição, 2022 / Biosafety and bioprotection 2nd edition, 2022

A Biossegurança e Bioprotecção em Laboratórios de Saúde Pública, Laboratórios de Análises Clínicas e instituções de pesquisa em saúde são áreas do conhecimento relativamente novas, reguladas em vários países por um conjunto de leis, normas, directrizes e procedimentos específicos. Actualmente, a Biossegurança e a Bioprotecção são vistas como disciplinas científicas que requerem um domínio de conhecimentos, habilidades e atitudes (CHA) multi-disciplinares. A aplicação dos princípios de Biossegurança e Bioprotecção é essencial para conter, prevenir, reduzir e eliminar os riscos de exposição por agentes microbiológicos, químicos, físicos, ergonómicos, acidentais e entre outros perigos que podem ou poderiam causar doenças de âmbito ocupacional. A Biossegurança e a Bioprotecção são também importantes para prevenir a exposição a riscos aos familiares de profissionais de saúde, utentes dos serviços de saúde, e para garantir a protecção do meio ambiente e da vida selvagem

Consideraciones de bioseguridad en la realización de la autopsia de casos positivos de COVID-19 / Biosafety considerations in the autopsy of positive COVID-19 cases

Fundamento: la autopsia permitirá dilucidar la patogenia y la correlación clínico-patológica de la infección por SARS-Cov-2, si bien su realización presenta riesgos de contagio, estos pueden ser minimizados al aplicar medidas de bioseguridad recomendadas por instituciones con gran experiencia en el manejo de enfermedades infecciosas. Objetivo: contribuir a la organización de la evidencia sobre la realización de autopsias de casos COVID-19 bajo niveles óptimos de bioseguridad. Métodos: se realizó una búsqueda en MEDLINE/PUBMED, se utilizaron las palabras: COVID-19, SARS-Cov-2, autopsia y bioseguridad. Se incluyeron guías y resoluciones de instituciones, series y presentaciones de casos con descripción de los procederes de autopsia. Los criterios de elegibilidad fueron: el país, número de autopsias realizadas, tipo de autopsia (completa o mínimamente invasiva), descripción de las medidas personales de bioseguridad y características del espacio físico de la morgue. Resultados: se obtuvieron 27 artículos que describen los procedimientos, equipos empleados y condiciones de infraestructura para garantizar la bioseguridad. De ellos, 13 describen la realización de la autopsia en una sala con presión negativa, y en 11 se describe la técnica y las medidas de bioseguridad a utilizar, con el uso de los equipos de protección personal. Se hallaron un total de cuatro documentos normativos o recomendaciones oficiales sobre los procedimientos a seguir para la realización de la autopsia con el mínimo de riesgos. Además de dos artículos que resumen dichas normativas. Conclusiones: los exámenes post mortem de casos COVID-19 se pueden realizar de manera segura con la aplicación de los equipos de protección personal adecuados (AU)

Background: the autopsy will allow elucidating the pathogenesis and the clinical-pathological correlation of the infection by SARS-Cov-2, although its performance presents risks of contagion, these can be minimized by applying bio-safety measures recommended by institutions with great experience in the management infectious diseases. Objective: to contribute to the organization of the evidence on the performance of autopsies of COVID-19 cases under optimal levels of bio-safety. Methods: a MEDLINE / PUBMED search was performed, using the words: COVID-19, SARS-Cov-2, autopsy and bio-safety. Guidelines and resolutions from institutions, series and case presentations were included with a description of the autopsy procedures. The eligibility criteria were: country, number of autopsies performed, type of autopsy (complete or minimally invasive), description of personal bio-safety measures, and characteristics of the physical space of the morgue. Results: 27 articles were obtained that describe the procedures, equipment used and infrastructure conditions to guarantee bio-security. Of these, 13 describe the autopsy in a room with negative pressure, and 11 describe the technique and bio-safety measures to be used, using personal protective equipment. A total of four normative documents or official recommendations were found on the procedures to follow to carry out the autopsy with the minimum of risks. In addition to 2 articles that summarize these regulations. Conclusions: post-mortem examinations of COVID-19 cases can be performed safely with the application of appropriate personal protective equipment (AU)

Porcionamento do leite humano rordenhado em ambiente hospitalar / Porcionamiento de la leche humana extraída en ambiente hospitalario / Portioning of expressed human milk in a hospital environment

Esta Norma Técnica tem por objetivo estabelecer os procedimentos exigíveis para garantir as condições de segurança no porcionamento do leite humano ordenhado em ambiente hospitalar, visando a garantia da qualidade em Bancos de Leite Humano e sua certificação.

Esta Norma Técnica tiene por objetivo establecer los procedimientos necesarios para garantizar las condiciones de seguridad en el porcionamiento de la leche humana extraída en ambiente hospitalario, con el fin de asegurar la calidad en los Bancos de Leche Humana y su certificación.

Biossegurança em banco de leite humano e postos de coleta de leite humano / Bioseguridad en bancos de leche humana y centros de recolección de leche humana / Biosafety in human milk banks and health posts human milk collection

Esta Norma Técnica tem por objetivo estabelecer as condições necessárias para a segurança na condução das ações executadas e prevenção de riscos em Bancos de Leite Humano e Postos de Coleta de Leite Humano, visando a garantia da qualidade nestes serviços e sua certificação

Esta Norma Técnica tiene por objetivo establecer las condiciones necesarias para la seguridad en la conducción de las acciones realizadas y la prevención de riesgos en los Bancos de Leche Humana y Centros de Recolección de Leche Humana, para garantizar la calidad de estos servicios y su certificación.

Leite humano ordenhado: verificação de sujidades / Human milk milked: dirtness checking

Esta Norma Técnica tem por objetivo estabelecer os critérios para avaliação do leite humano ordenhado cru no que se refere à presença de sujidades, visando a garantia da qualidade em Bancos de Leite Humano e sua certificação.

Higiene e conduta: acompanhantes e visitantes / Hygiene and conduct: companions and visitors

Esta Norma Técnica tem por objetivo estabelecer as condições de higiene e conduta de acompanhantes das usuárias e visitantes em Bancos de Leite Humano e em Postos de Coleta de Leite Humano, visando a garantia da qualidade nestes serviços e sua certificação.

Higiene e conduta: doadoras / Hygiene and conduct: donors

Esta Norma Técnica tem por objetivo estabelecer as condições de higiene das doadoras no processo de extração de leite humano no domicílio, em Bancos de Leite Humano e em Postos de Coleta de Leite Humano, visando a garantia da qualidade nestes serviços e sua certificação.

Higiene e conduta: funcionários / Hygiene and conduct: employees

Esta Norma Técnica fixa as condições exigíveis para higiene de funcionários em Bancos de Leite Humano e em Postos de Coleta de Leite Humano, visando a garantia da qualidade nestes serviços e sua certificação.

The impact of biosafety enhancement on stat laboratory quality metrics: Lessons from the COVID-19 pandemic.

OBJECTIVE: It is unclear if implementation of biosafety action plans in response to the COVID-19 pandemic has affected laboratory quality metrics. METHODS: This retrospective study used quality data, including turnaround time (TAT) and number/type of unacceptable specimens from a stat laboratory supporting an outpatient medical clinic serving predominantly elderly cancer patients. Four months of data from the height of the COVID-19 pandemic (March-June 2020) were compared to the same months in 2019. RESULTS: March-May 2020 test volumes were decreased compared to 2019. June 2020 test volume was slightly increased compared to 2019. TATs in 2020 were similar/ slightly improved compared to the same months in 2019, due to shortened collect to receive and receive to verify TATs. The number and types of unacceptable specimens were similar in 2020 and 2019. CONCLUSIONS: Despite the challenges to the system caused by the pandemic, laboratory quality metrics were maintained.

Challenges in the establishment of a biosafety testing laboratory for COVID-19 in Bangladesh.

At the beginning of the coronavirus disease 2019 (COVID-19) pandemic in Bangladesh, there was a scarcity of ideal biocontainment facilities to detect the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a risk group of 3 organisms. Molecular detection of SARS-CoV-2 must be performed in a BSL-2 laboratory with BSL-3-equivalent infection prevention and control practices. Establishing these facilities within a short timeframe proved to be an enormous challenge, including locating a remote space distant from the university campus to establish a laboratory, motivating the laboratory staff to work with a novel pathogen without any prior experience, allocation of funds for essential equipment and accessories, and arrangement of a safe waste management system for environmental hazard reduction. This report also highlights several limitations, such as the facility's architectural design that did not follow the biosafety guidelines, lack of continuous flow of funds, and an inadequate number of laboratory personnel. This article describes various efforts taken to overcome the challenges during the establishment of this facility that may be adopted to create similar facilities in other regions of the country. Establishing a BSL-2 laboratory with BSL-3-equivalent infection prevention and control practices will aid in the early detection of a large number of cases, thereby isolating persons with COVID-19, limiting the transmission of SARS-CoV-2, and promoting a robust public health response to contain the pandemic.

Biosafety during a pandemic: shared resource laboratories rise to the challenge.

Biosafety has always been an important aspect of daily work in any research institution, particularly for cytometry Shared Resources Laboratories (SRLs). SRLs are common-use spaces that facilitate the sharing of knowledge, expertise, and ideas. This sharing inescapably involves contact and interaction of all those within this working environment on a daily basis. The current pandemic caused by SARS-CoV-2 has prompted the re-evaluation of many policies governing the operations of SRLs. Here we identify and review the unique challenges SRLs face in maintaining biosafety standards, highlighting the potential risks associated with not only cytometry instrumentation and samples, but also the people working with them. We propose possible solutions to safety issues raised by the COVID-19 pandemic and provide tools for facilities to adapt to evolving guidelines and future challenges.