biorisk

  • 文章类型: Journal Article
    生物安全和生物安保的组织文化对于有效管理跨界动物疾病至关重要。这项工作的一个重要方面是控制在兽医实验室中研究的重要病原体。蒂尔基耶是口蹄疫(FMD)病毒流行和无病的国家之一,它有一个专门研究口蹄疫诊断的独特机构,control,和疫苗生产。在本研究所内建立组织安全文化,增强对FMD安全处理重要性的认识,4名以前接受过biorisk管理培训的工作人员开发并向所有研究所工作人员提供培训。根据直接或间接使用口蹄疫病毒的工作描述,该研究所的173名人员分为3组。所有3个小组都接受了关于生物安全的培训,生物安全,biorisk意识,和内部威胁;培训的长度因小组而异。所有研究所人员中有四分之三(n=130,75%)完成了培训,并被要求在培训前后使用Likert量表进行知识调查。这些参与者中的大多数(n=104,80%)完成了培训前和培训后的调查。所有3个培训组的培训后调查显示,提高意识高于基线分数,3组得分均达到目标阈值目标。第2组表明,他们通过经验获得的一些知识和习惯是不正确的。几个单独问题的分数在训练后下降,这些结果需要进一步评估。总体培训结果促使该研究所定期向员工提供最新信息,以维持组织安全文化。通过这项研究,该研究所现在有一个专门的biorisk管理代表小组。这项工作为依靠工作人员经验来培养生物安全和生物安保组织文化的既定机构敲响了警钟。
    An organizational culture of biosafety and biosecurity is critical for effective management of transboundary animal diseases. One essential aspect of this work is keeping important pathogens studied in veterinary laboratories under control. Türkiye is among the countries that are both endemic and disease-free for foot-and-mouth disease (FMD) virus, and it has a unique institute dedicated to FMD diagnosis, control, and vaccine production. To build an organizational safety culture within this institute and strengthen awareness of the importance of safe and secure handling of FMD, 4 staff members previously trained in biorisk management developed and provided trainings to all institute staff. The institute\'s 173 personnel were divided into 3 groups by job description based on direct or indirect work with FMD virus. All 3 groups received training that addressed biosecurity, biosafety, biorisk awareness, and insider threat; the trainings varied in length by group. Three-quarters (n=130, 75%) of all institute staff completed their training and were asked to complete knowledge surveys using a Likert scale survey before and after their training. A majority (n=104, 80%) of those participants completed both the pretraining and posttraining surveys. All 3 training groups\' posttraining surveys showed improved awareness above baseline scores, and all 3 groups scores reached the targeted threshold goal. Group 2 demonstrated a realization that some of the knowledge and habits they had acquired through experience were incorrect. Scores for several individual questions decreased at posttraining, and these results will need further evaluation. The overall training results prompted the institute to provide periodic updates to employees to sustain the organizational safety culture. With this study, the institute now has a dedicated group of biorisk management representatives. This work serves as a wake-up call for established institutions that rely on staff experience to foster an organizational culture of biosafety and biosecurity.
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  • 文章类型: Journal Article
    人工智能合成生物学具有巨大的潜力,但也显著增加了生物多样性,并带来了一系列新的双重用途问题。考虑到通过结合新兴技术而设想的巨大创新,情况很复杂,人工智能合成生物学有可能将生物工程扩展到工业生物制造。然而,文献综述表明,诸如保持合理的创新范围等目标,或者更雄心勃勃地培育巨大的生物经济不一定与生物安全形成对比,但需要手牵手。本文介绍了有关问题的文献综述,并描述了跨命令与控制选项的新兴政策和实践框架,管理,自下而上,和自由放任的治理。如何实现预警系统,使实验室能够预防和缓解未来人工智能生物危害,从故意滥用,或者来自公共领域,会不断需要进化,和适应性,交互式方法应该出现。尽管Biorisk受既定治理制度的约束,科学家们普遍遵守生物安全协议,甚至是实验性的,但是科学家的合法使用可能会导致意想不到的发展。由生成AI实现的聊天机器人的最新进展重新引发了人们的担忧,即先进的生物洞察力更容易落入恶性个人或组织手中。鉴于这些问题,社会需要重新思考人工智能合成生物学应该如何管理。想象当前挑战的建议方法是打痣治理,尽管新兴的解决方案可能也没有太大不同。
    AI-enabled synthetic biology has tremendous potential but also significantly increases biorisks and brings about a new set of dual use concerns. The picture is complicated given the vast innovations envisioned to emerge by combining emerging technologies, as AI-enabled synthetic biology potentially scales up bioengineering into industrial biomanufacturing. However, the literature review indicates that goals such as maintaining a reasonable scope for innovation, or more ambitiously to foster a huge bioeconomy do not necessarily contrast with biosafety, but need to go hand in hand. This paper presents a literature review of the issues and describes emerging frameworks for policy and practice that transverse the options of command-and-control, stewardship, bottom-up, and laissez-faire governance. How to achieve early warning systems that enable prevention and mitigation of future AI-enabled biohazards from the lab, from deliberate misuse, or from the public realm, will constantly need to evolve, and adaptive, interactive approaches should emerge. Although biorisk is subject to an established governance regime, and scientists generally adhere to biosafety protocols, even experimental, but legitimate use by scientists could lead to unexpected developments. Recent advances in chatbots enabled by generative AI have revived fears that advanced biological insight can more easily get into the hands of malignant individuals or organizations. Given these sets of issues, society needs to rethink how AI-enabled synthetic biology should be governed. The suggested way to visualize the challenge at hand is whack-a-mole governance, although the emerging solutions are perhaps not so different either.
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  • 文章类型: Journal Article
    历史上,对导致人类疾病的微生物研究的监管一直集中在“坏虫”的分类学清单上。然而,鉴于我们通过廉价的基因组测序增加了对这些病原体的了解,微生物发病机理研究了50年,以及合成生物学家不断发展的能力,这种方法的局限性是显而易见的。随着科学和公众对生物安全和生物安保的高度关注,以及美国当局对两用研究监督的持续审查,本文建议将关注序列(SoCs)纳入控制病原体基因工程的生物管理系统中。SoCs能够在所有感染人类文明所关注的宿主的微生物中致病。在这里,我们回顾了SoCs(FunSoCs)的功能,并讨论了它们如何为涉及传染性病原体的潜在问题研究结果带来清晰度。我们认为,用FunSoCs注释SoCs有可能提高双重用途研究在发生之前被科学家和监管机构认可的可能性。
    Regulation of research on microbes that cause disease in humans has historically been focused on taxonomic lists of \'bad bugs\'. However, given our increased knowledge of these pathogens through inexpensive genome sequencing, 5 decades of research in microbial pathogenesis, and the burgeoning capacity of synthetic biologists, the limitations of this approach are apparent. With heightened scientific and public attention focused on biosafety and biosecurity, and an ongoing review by US authorities of dual-use research oversight, this article proposes the incorporation of sequences of concern (SoCs) into the biorisk management regime governing genetic engineering of pathogens. SoCs enable pathogenesis in all microbes infecting hosts that are \'of concern\' to human civilization. Here we review the functions of SoCs (FunSoCs) and discuss how they might bring clarity to potentially problematic research outcomes involving infectious agents. We believe that annotation of SoCs with FunSoCs has the potential to improve the likelihood that dual use research of concern is recognized by both scientists and regulators before it occurs.
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  • 文章类型: Journal Article
    背景:产志贺毒素的大肠杆菌(STEC)是一种人畜共患病原体,它是从各种动物传播的,尤其是牛对人类的污染,水,与受感染的环境或动物接触或接触。STEC菌株在人类中引起胃肠道并发症的能力是由于志贺毒素(sxt)的产生。然而,多药耐药STEC菌株的传播与疾病结局的严重程度和耐药基因在其他病原体中的水平传播相关.其结果已成为对公众健康的重大威胁,动物健康,食品安全,和环境。因此,这项研究的目的是调查从Zagazig市的食品和牛粪便样本中分离出的肠大肠杆菌O157的抗菌谱,Al-Sharkia,埃及,并揭示志贺毒素基因stx1和stx2作为多重耐药分离株中的毒力因子。除此之外,部分16SrRNA测序用于获得的STEC分离株的鉴定和遗传编码。
    结果:从Zagazig市的不同地理区域收集了总共65个样本,Al-Sharkia-埃及,分为:15鸡肉(C),10午餐会(L),10个汉堡包(H),和30头牛粪便(CF)。从65个样本中,只有10个样本(一个来自H,和9来自CF),在最可能数量(MPN)技术的最后一步,在山梨糖醇MacConkey琼脂培养基上鉴定为无色菌落的可疑大肠杆菌O157。8个分离株(全部来自CF)被鉴定为多重耐药(MDR),因为它们对三种抗生素的多重耐药(MAR)指数≥0.23,并通过标准的Kirby-Bauer圆盘扩散法评估。这八个分离株对阿莫西林/克拉维酸表现出完全抗性(100%),和高频率的电阻(90%,70%,60%,60%,和40%)对头孢西丁,Polymixin,红霉素,头孢他啶,还有哌拉西林,分别。这八个MDR大肠杆菌O157进行血清学测定以确认其血清型。只有两个分离株(CF8和CF13),都来自CF,对抗血清O157和H7显示出强烈的凝集作用,以及对MAR指数最高(0.62)的13种所用抗生素中的8种具有抗性。通过PCR技术评估毒力基因志贺毒素(stx1和stx2)的存在。证实CF8携带stx2,而CF13携带stx1和stx2两个基因。通过部分分子16SrRNA测序鉴定了两个分离株,并具有登录号(Acc。不。)的LC666912和基因库上的LC666913。系统发育分析表明,CF8和CF13与大肠杆菌H7菌株高度同源(98%),和(100%)大肠杆菌DH7。
    结论:这项研究的结果为携带志贺毒素stx1和/或stx2的大肠杆菌O157:H7的发生提供了证据,对人类和兽医学中常用的抗生素耐药频率很高,在Zagazig市,Al-Sharkia,埃及。这对动物水库和食品造成了很大程度的公共卫生风险,因为容易传播,导致疫情爆发,并将抗性基因转移到动物的其他病原体,人类,和植物。因此,环境,畜牧业,和食品监控,还有,临床感染控制,必须加强以避免MDR病原体的额外传播,尤其是MDRSTEC菌株。
    Shiga toxin-producing Escherichia coli (STEC) is a zoonotic pathogen, that is transmitted from a variety of animals, especially cattle to humans via contaminated food, water, feaces or contact with infected environment or animals. The ability of STEC strains to cause gastrointestinal complications in human is due to the production of Shiga toxins (sxt). However, the transmission of multidrug-resistance STEC strains are linked with a severity of disease outcomes and horizontal spread of resistance genes in other pathogens. The result of this has emerged as a significant threat to public health, animal health, food safety, and the environment. Therefore, the purpose of this study is to investigate the antibiogram profile of enteric E. coli O157 isolated from food products and cattle faeces samples in Zagazig City, Al-Sharkia, Egypt, and to reveal the presence of Shiga toxin genes stx1 and stx2 as virulence factors in multidrug-resistant isolates. In addition to this, the partial 16S rRNA sequencing was used for the identification and genetic recoding of the obtained STEC isolates.
    There was a total of sixty-five samples collected from different geographical regions at Zagazig City, Al-Sharkia-Egypt, which were divided into: 15 chicken meat (C), 10 luncheon (L), 10 hamburgers (H), and 30 cattle faeces (CF). From the sixty-five samples, only 10 samples (one from H, and 9 from CF) were identified as suspicious E. coli O157 with colourless colonies on sorbitol MacConkey agar media with Cefixime- Telurite supplement at the last step of most probable number (MPN) technique. Eight isolates (all from CF) were identified as multidrug-resistant (MDR) as they showed resistance to three antibiotics with multiple antibiotic resistance (MAR) index ≥ 0.23, which were assessed by standard Kirby-Bauer disc diffusion method. These eight isolates demonstrated complete resistance (100%) against amoxicillin/clavulanic acid, and high frequencies of resistance (90%, 70%, 60%,60%, and 40%) against cefoxitin, polymixin, erythromycin, ceftazidime, and piperacillin, respectively. Those eight MDR E. coli O157 underwent serological assay to confirm their serotype. Only two isolates (CF8, and CF13), both from CF, were showed strong agglutination with antisera O157 and H7, as well as resistance against 8 out of 13 of the used antibiotics with the highest MAR index (0.62). The presence of virulence genes Shiga toxins (stx1 and stx2) was assessed by PCR technique. CF8 was confirmed for carrying stx2, while CF13 was carrying both genes stx1, and stx2. Both isolates were identified by partial molecular 16S rRNA sequencing and have an accession number (Acc. No.) of LC666912, and LC666913 on gene bank. Phylogenetic analysis showed that CF8, and CF13 were highly homologous (98%) to E. coli H7 strain, and (100%) to E. coli DH7, respectively.
    The results of this study provides evidence for the occurrence of E. coli O157:H7 that carries Shiga toxins stx1 and/or stx2, with a high frequency of resistance to antibiotics commonly used in human and veterinary medicine, in Zagazig City, Al-Sharkia, Egypt. This has a high extent of public health risk posed by animal reservoirs and food products with respect to easy transmission causing outbreaks and transfer resistance genes to other pathogens in animal, human, and plants. Therefore, environmental, animal husbandry, and food product surveillance, as well as, clinical infection control, must be strengthened to avoid the extra spread of MDR pathogens, especially MDR STEC strains.
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  • 文章类型: Journal Article
    未经证实:COVID-19诊断是大流行早期阶段最紧迫的需求之一。其整个过程具有固有的生物安全风险,如果管理不当和减轻,可能会危及生命。认识到这一重要方面,卫生部(DOH)对所有实验室和机构实施了生物安全培训要求,然后才能进行COVID-19诊断测试。但是随着强制封锁,无法进行常规的面对面训练。为了满足这一需求,生物安全教育和意识培训COVID-19在线计划由菲律宾大学马尼拉国家生物安全和生物安保培训中心提供。
    UNASSIGNED:此在线培训计划实施了通过Canvas学习管理系统提供的远程学习方法。它由七个关于生物安全的模块组成,这些模块足以使参与者获得有效实施生物安全管理系统的信息。根据测验对参与者进行了评估,考试,和案例分析。结业证书颁发给通过所有评估方法的参与者。
    UNASSIGNED:共有3371名来自各种医疗专业的学员通过并获得了证书。到2020年底,这导致了超过100个DOH认可的COVID-19检测实验室。
    UNASSIGNED:该计划的在线可用性被证明是解决独特问题的有效创新解决方案。因此,该培训计划表明,生物安全培训可以有效地在线和远程学习方式进行。
    UNASSIGNED: COVID-19 diagnosis was one of the most pressing needs during the early stages of the pandemic. Its entire procedure has inherent biosafety risks that if not properly managed and mitigated can be life threatening. Cognizant of this vital aspect, the Department of Health (DOH) imposed a biosafety training requirement to all laboratories and institutions before they could perform COVID-19 diagnostic testing. But with the mandatory lockdown, conventional face-to-face training could not be conducted. To address this need, the Biosafety Education and Awareness Training COVID-19 Online Program was offered by the National Training Center for Biosafety and Biosecurity of the University of the Philippines Manila.
    UNASSIGNED: This online training program implemented a distance learning approach made available through the Canvas Learning Management System. It consisted of seven modules on biosafety that were sufficient enough to capacitate the participants with information for them to effectively implement a biorisk management system. The participants were evaluated based on quiz, examination, and case analysis. Certificates of completion were awarded to participants who passed all evaluation methods.
    UNASSIGNED: A total of 3371 trainees from various medical professions passed and obtained the certificate. This resulted in >100 DOH-accredited COVID-19 testing laboratories by the end of 2020.
    UNASSIGNED: The online availability of this program proved to be an effective innovative solution to a unique problem. Therefore, this training program demonstrated that biosafety training can be effectively conducted online and in a distance learning approach.
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  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    The pervasive nature of infections causing major outbreaks have elevated biosafety and biosecurity as a fundamental component for resilient national laboratory systems. In response to international health security demands, the Global Health Security Agenda emphasizes biosafety as one of the prerequisites to respond effectively to infectious disease threats. However, biosafety management systems (BMS) in low-medium income countries (LMIC) remain weak due to fragmented implementation strategies. In addition, inefficiencies in implementation have been due to limited resources, inadequate technical expertise, high equipment costs, and insufficient political will. Here we propose an approach to developing a strong, self-sustaining BMS based on extensive experience in LMICs. A conceptual framework incorporating 15 key components to guide implementers, national laboratory leaders, global health security experts in building a BMS is presented. This conceptual framework provides a holistic and logical approach to the development of a BMS with all critical elements. It includes a flexible planning matrix with timelines easily adaptable to different country contexts as examples, as well as resources that are critical for developing sustainable technical expertise.
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  • 文章类型: Journal Article
    Novel coronavirus infection [coronavirus disease 2019 (COVID-19)] has spread to more than 203 countries of various regions including Africa, America, Europe, South East Asia and Western Pacific. The WHO had declared COVID-19 as the global public health emergency and subsequently as pandemic because of its worldwide spread. It is now one of the top-priority pathogens to be dealt with, because of high transmissibility, severe illness and associated mortality, wide geographical spread, lack of control measures with knowledge gaps in veterinary and human epidemiology, immunity and pathogenesis. The quick detection of cases and isolating them has become critical to contain it. To meet the increasing demand of the diagnostic services, it is necessary to enhance and expand laboratory capabilities since existing laboratories cannot meet the emerging demand. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a BSL-2 (Biosafety Level 2) agent and needs to be handled in biosafety cabinet using standard precautions. This review highlights minimum requirements for the diagnostic laboratories opting testing of material for the diagnosis of COVID-19 and associated biorisk to the individuals and to the community.
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  • 文章类型: Journal Article
    The innovations and developments in microbiology, biomedical sciences, and biotechnology come along with the challenges of biological risk (biorisk). Biorisk is defined as the \"combination of the probability of occurrence of harm and the severity of that harm where the source of harm is a biological agent or toxin.\" Biorisk is a borderless challenge to the global community. Hence, all universities, colleges, centers of bio-excellence, and institutions of higher learning can and should do their bit to educate technical members, academicians, students and stakeholders (LASS) for the efficient and comprehensive biorisk management (BRM) for our and future generations safety and sustainability.
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  • 文章类型: Journal Article
    生物工程的进步可能会对全球社会产生重大影响。为了探索这些潜在的影响,我们进行了地平线扫描练习,以捕捉生物工程带来的机遇和风险的一系列观点。我们首先确定了70个潜在问题,然后使用一个迭代过程来优先考虑我们认为正在出现的20个问题,产生潜在的全球影响,并且在生物工程领域之外相对未知。发现的问题可能会引起研究人员的兴趣,卫生等部门的企业和政策制定者,能源,农业与环境。
    Advances in biological engineering are likely to have substantial impacts on global society. To explore these potential impacts we ran a horizon scanning exercise to capture a range of perspectives on the opportunities and risks presented by biological engineering. We first identified 70 potential issues, and then used an iterative process to prioritise 20 issues that we considered to be emerging, to have potential global impact, and to be relatively unknown outside the field of biological engineering. The issues identified may be of interest to researchers, businesses and policy makers in sectors such as health, energy, agriculture and the environment.
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