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.

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.

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.

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.

Pandemia de Covid-19 e o uso racional de equipamentos de proteção individual / Covid-19 pandemic and rational use of personal protective equipment / Pandemia de Covid-19 y uso racional de equipos de protección personal

Objetivo: descrever as recomendações sobre o uso racional e seguro dos equipamentos de proteção individual (EPI) no transcorrer da cadeia assistencial de pessoas com suspeita ou confirmação de contaminação pelo novo coronavírus. Conteúdo: o novo coronavírus é responsável pela doença Covid-19, e dentre as pessoas com maior risco de desenvolver a infecção estão os trabalhadores de saúde, devido ao contato muito próximo a pacientes. Desse modo, a utilização de EPI é recomendação prioritária a estes trabalhadores. Todavia, em função do desabastecimento internacional e nacional relacionado a estes equipamentos, o uso racional é fundamental a fim de evitar que o impacto do desabastecimento seja ainda maior. Conclusão: o uso de EPI é indispensável aos trabalhadores de saúde durante a pandemia de Covid-19, contudo, é imprescindível coordenar a cadeia de fornecimento destes insumos, implementar estratégias que minimizem a necessidade de EPI e garantir o uso de maneira adequada.

Objective: to describe the recommendations on the rational, safe use of personal protective equipment (PPE) throughout the chain of care for people with suspected or confirmed contamination by the new coronavirus. Content: the new coronavirus is responsible for the disease Covid-19, and among those at high risk of infection are health workers in very close contact with patients. It is thus a priority recommendation for these workers to use PPE. However, international and national shortages of this equipment make rational use essential in order to prevent even greater impact from these shortages. Conclusion: it is essential that health workers use PPE during the Covid-19 pandemic, but it is also essential to coordinate the supply chain for these inputs, implement strategies that minimize the need for PPE and ensure proper use.

Objetivo: describir las recomendaciones sobre el uso racional y seguro del equipo de protección personal (EPP) en toda la cadena de atención para las personas con sospecha o confirmación de contaminación por el nuevo coronavirus. Contenido: el nuevo coronavirus es responsable de la enfermedad de Covid-19, y entre aquellos con alto riesgo de infección se encuentran los trabajadores de la salud en contacto muy cercano con los pacientes. Por lo tanto, es una recomendación prioritaria para estos trabajadores usar EPP. Sin embargo, la escasez internacional y nacional de este equipo hace que el uso racional sea esencial para evitar un impacto aún mayor de esta escasez. Conclusión: es esencial que los trabajadores de la salud usen EPP durante la pandemia de Covid-19, pero también es esencial coordinar la cadena de suministro para estos insumos, implementar estrategias que minimicen la necesidad de EPP y garantizar un uso adecuado.

Parada cardiorrespiratória na pandemia por coronavírus: revisão compreensiva da literatura / Cardiorespiratory arrest in a coronavirus pandemic: comprehensive literature review / Paro cardiorrespiratorio en una pandemia de coronavirus: revisión exhaustiva de la literatura

Objetivo: apresentar atualizações para a ressuscitação cardiopulmonar em pacientes suspeitos e confirmados com COVID-19. Método: revisão compreensiva da literatura, com síntese narrativa das evidências de diretrizes e recomendações da Organização Mundial de Saúde, Associação de Medicina Intensiva Brasileira, American Heart Association, Resuscitation Council UK, American College of Surgions Committee on Trauma e National Association of Emergency Medical Technicians. Resultados: as principais atualizações trazem informações sobre especificidades das manobras de ressuscitação cardiopulmonar; preparação do ambiente, recursos humanos e materiais, reconhecimento da parada cardiorrespiratória e ações iniciais; estratégias de ventilação e acesso invasivo da via aérea; ajustes do ventilador mecânico e manobras de ressuscitação cardiopulmonar em pacientes pronados. Considerações finais: profissionais de saúde envolvidos no atendimento à parada cardiorrespiratória de pacientes suspeitos e/ou confirmados com COVID-19 podem encontrar inúmeros desafios, portanto devem seguir com rigor o protocolo estabelecido para maximizar a efetividade das manobras de ressuscitação e minimizar o risco de contágio pelo vírus e sua disseminação.

Objective: to present updates for cardiopulmonary resuscitation in suspected and confirmed patients with COVID-19. Method: comprehensive literature review with narrative synthesis of the evidence of guidelines and recommendations from World Health Organization, Associação de Medicina Intensiva Brasileira, American Heart Association, Resuscitation Council UK, American College of Surgions Committee on Trauma and National Association of Emergency Medical Technicians. Results: the main updates bring information about the specifics of cardiopulmonary resuscitation maneuvers; preparation of the environment and human and material resources, recognition of cardiorespiratory arrest and initial actions; ventilation and invasive airway access strategies; mechanical ventilator adjustments and cardiopulmonary resuscitation maneuvers in patients in the prone position. Final considerations: health professionals involved in the care of cardiorespiratory arrest of suspected and/or confirmed patients with COVID-19 can face numerous challenges, so they must strictly follow the protocol established to maximize the effectiveness of resuscitation maneuvers and minimize the risk of contagion by the virus and its spread.

Objetivo: apresentar actualizaciones para la reanimación cardiopulmonar en pacientes sospechos os y confirmados con COVID-19. Método: revisión exhaustiva de la literatura con síntesis narrativa de la evidencia de guías y recomendaciones de la Organización Mundial de la Salud, Associação de Medicina Intensiva Brasileira, American Heart Association, Resuscitation Council UK, American College of Surgions Committee on Trauma and National Association of Emergency Medical Technicians. Resultados: las principales actualizaciones aportan información sobre los detalles de las maniobras de reanimación cardiopulmonar; preparación del medio ambiente y recursos humanos y materiales, reconocimiento de paro cardiorrespiratorio y acciones iniciales; estrategias de ventilación y acceso invasivo a las vías aéreas; ajustes del ventilador mecánico y maniobras de reanimación cardiopulmonar en pacientes en decúbito prono. Consideraciones finales: los profesionales de la salud involucrados en la atención del paro cardiorrespiratorio de pacientes sospechosos y/o confirmados con COVID-19 pueden enfrentar numerosos desafíos, por lo que deben seguir estrictamente el protocolo establecido para maximizar la efectividad de las maniobras de reanimación y minimizar el riesgo de contagio por el virus y supropagación.

Reasons for and barriers to biosafety and biosecurity training in health-related organizations in Africa, Middle East and Central Asia: findings from GIBACHT training needs assessments 2018-2019.

INTRODUCTION: the Global-Partnership-Initiated-Biosecurity-Academia for Controlling Health Threats (GIBACHT) consortium conducts a biosafety and biosecurity training for fellows from Africa, the Middle East and Asia. To achieve a multiplier effect, fellows conduct trainings in their own organizations. It was during such trainings that training needs assessments were done assessing reasons for and barriers to biosafety and biosecurity training. METHODS: this was a cross sectional assessment. Trainings were conducted from April to July 2018 and April to June 2019. In 2018, training needs were explored using a structured tool. Responses were coded using manifest content analysis and key issues identified. In 2019, respondents quantified the identified key issues using a Likert scale. Proportions of those who strongly agreed, agreed, neither agreed nor disagreed, disagreed or strongly disagreed were calculated and results presented in tables and charts. RESULTS: in 2018 and 2019, there were 183 and 191 respondents respectively. About 96% of respondents in 2018 supported training in biosafety and biosecurity citing individual, community and global benefits. Barriers highlighted included governance, financial, human resource, information and infrastructure challenges. In 2019, majority of respondents indicated inadequate guidelines dissemination, lack of financial resources, inadequate personnel, lack of equipped laboratories and lack of instructional materials among major barriers. CONCLUSION: support for biosafety and biosecurity training was high though systemic barriers exist. Improving human resource capacity and provision of instructional materials can be achieved through training programs. However, systemic assessments need to be done before each training as different organizations have different barriers.