Biosafety and Health最新文献_第10页

Hyperoncotic human albumin solutions for intravenous fluid therapy: Effectiveness of pathogen safety and purification methods, and clinical safety 用于静脉输液治疗的高肿瘤学人白蛋白溶液：病原体安全性和纯化方法的有效性以及临床安全性

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2022.12.004

Toby Simon , Philipp Schumann , Michael Bieri , Kathrin Schirner , Eleonora Widmer

{"title":"Hyperoncotic human albumin solutions for intravenous fluid therapy: Effectiveness of pathogen safety and purification methods, and clinical safety","authors":"Toby Simon , Philipp Schumann , Michael Bieri , Kathrin Schirner , Eleonora Widmer","doi":"10.1016/j.bsheal.2022.12.004","DOIUrl":"10.1016/j.bsheal.2022.12.004","url":null,"abstract":"<div><p>Albumin solutions derived from human plasma have demonstrated clinical benefits as intravenous fluid therapy in clinical settings such as liver disease, sepsis, intensive care, and surgery. For all plasma-derived medicinal products, there is a potential risk from pathogens, including relevant blood-borne viruses, emerging viruses, and prion proteins. To minimize the risk of transmissible infections, the production of human albumin solutions includes rigorous donor selection and plasma testing, and effective pathogen removal and inactivation methods such as fractionation and pasteurization. Compliance with international pharmacopeial standards for purity and prekallikrein activator and aluminum content is crucial, as is post-marketing pharmacovigilance for the continuous monitoring of adverse events. This review focuses on the effectiveness of manufacturing methods in the production of plasma-derived albumin, to ensure the safety of hyperoncotic solutions for volume expansion. We evaluated evidence identified through online database (PubMed) searches and from unpublished sources, on the manufacturing and pathogen safety of plasma-derived albumin solutions. The results confirmed the already established and evolving pathogen reduction capacity of the reviewed manufacturing methods. Up-to-date post-marketing pharmacovigilance data and log<sub>10</sub> reduction factors for known and emerging pathogens during albumin production are included. Towards the goal of ever-increasing clinical safety, potential areas of improvement, such as compliance rates for the completion of donor health questionnaires, are also discussed. Taken together, the current manufacturing and pathogen reduction steps result in albumin products of greater purity than previous-generation products, with a high margin of pathogen safety against known and emerging pathogens, such as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).</p></div>","PeriodicalId":36178,"journal":{"name":"Biosafety and Health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46821097","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Review of science and technology innovation policies in major innovative-oriented countries in response to the COVID-19 pandemic 主要创新型国家应对新冠肺炎大流行的科技创新政策回顾

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2022.12.001

Tao Yun

引用次数: 1

Comparative analysis of technical requirements for Heating, Ventilating, and Air Conditioning (HVAC) systems in high-biocontainment facility standards 高生物防护设施标准中供热、通风和空调(HVAC)系统技术要求的比较分析

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2022.12.003

Lei Liang , Xinfang Hong , Bing Lu , Xuedong Yu , Guoqing Cao , Xin Feng , Quan Zhou , Yanqin Wang , Donglai Wu , Rong Wang

引用次数: 0

Temporal dynamics of SARS-CoV-2 genome mutations that occurred in vivo on an aircraft 飞机上体内发生的SARS-CoV-2基因组突变的时间动态

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2022.10.004

Yaqing He , Shengyuan Dang , Wentai Ma , Long Chen , Renli Zhang , Shujiang Mei , Xinyi Wei , Qiuying Lv , Bo Peng , Ying Sun , Dongfeng Kong , Jiancheng Chen , Shimin Li , Xiujuan Tang , Qingju Lu , Can Zhu , Zhigao Chen , Jia Wan , Xuan Zou , Mingkun Li , Jianwei Wang

{"title":"Temporal dynamics of SARS-CoV-2 genome mutations that occurred in vivo on an aircraft","authors":"Yaqing He , Shengyuan Dang , Wentai Ma , Long Chen , Renli Zhang , Shujiang Mei , Xinyi Wei , Qiuying Lv , Bo Peng , Ying Sun , Dongfeng Kong , Jiancheng Chen , Shimin Li , Xiujuan Tang , Qingju Lu , Can Zhu , Zhigao Chen , Jia Wan , Xuan Zou , Mingkun Li , Jianwei Wang","doi":"10.1016/j.bsheal.2022.10.004","DOIUrl":"https://doi.org/10.1016/j.bsheal.2022.10.004","url":null,"abstract":"<div><p>We analyzed variations in the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) genome during a flight-related cluster outbreak of coronavirus disease 2019 (COVID-19) in Shenzhen, China, to explore the characteristics of SARS-CoV-2 transmission and intra-host single nucleotide variations (iSNVs) in a confined space. Thirty-three patients with COVID-19 were sampled, and 14 were resampled 3–31 days later. All 47 nasopharyngeal swabs were deep-sequenced. iSNVs and similarities in the consensus genome sequence were analyzed. Three SARS-CoV-2 variants of concern, Delta (n = 31), Beta (n = 1), and C.1.2 (n = 1), were detected among the 33 patients. The viral genome sequences from 30 Delta-positive patients had similar SNVs; 14 of these patients provided two successive samples. Overall, the 47 sequenced genomes contained 164 iSNVs. Of the 14 paired (successive) samples, the second samples (T2) contained more iSNVs (median: 3; 95% confidence interval [95% CI]: 2.77–10.22) than did the first samples (T1; median: 2; 95% CI: 1.63–3.74; Wilcoxon test, <em>P</em> = 0.021). 38 iSNVs were detected in T1 samples, and only seven were also detectable in T2 samples. Notably, T2 samples from two of the 14 paired samples had additional mutations than the T1 samples. The iSNVs of the SARS-CoV-2 genome exhibited rapid dynamic changes during a flight-related cluster outbreak event. Intra-host diversity increased gradually with time, and new site mutations occurred <em>in vivo</em> without a population transmission bottleneck. Therefore, we could not determine the generational relationship from the mutation site changes alone.</p></div>","PeriodicalId":36178,"journal":{"name":"Biosafety and Health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49732553","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 1

The prevalence and distribution of aminoglycoside resistance genes 氨基糖苷类耐药基因的流行与分布

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2023.01.001

Yuan Zhang , Ning Zhang , Mengyu Wang , Ming Luo , Yao Peng , Zhenpeng Li , Jialiang Xu , Meiling Ou , Biao Kan , Xu Li , Xin Lu

{"title":"The prevalence and distribution of aminoglycoside resistance genes","authors":"Yuan Zhang , Ning Zhang , Mengyu Wang , Ming Luo , Yao Peng , Zhenpeng Li , Jialiang Xu , Meiling Ou , Biao Kan , Xu Li , Xin Lu","doi":"10.1016/j.bsheal.2023.01.001","DOIUrl":"10.1016/j.bsheal.2023.01.001","url":null,"abstract":"<div><p>Choosing the appropriate antibiotics to treat bacterial infections has grown more challenging as a result of the emergence of antibiotic-resistant bacteria. Aminoglycosides, as broad-spectrum antibiotics, are increasingly being used clinically; however, for most effective employment of aminoglycosides, a comprehensive understanding of aminoglycoside resistance genes’ prevalence and dissemination is required. Therefore, to better understand the global resistance status of aminoglycoside antibiotics and the prevalence of antibiotic-resistance genes (ARGs) in various bacterial species, this systematic review gathered relevant data from multiple studies. Two primary resistance mechanisms—aminoglycoside enzymatic modification and 16S rRNA methylation—were assessed, and the prevalence of the corresponding ARGs was described. The coexistence of aminoglycoside ARGs with other ARGs was also demonstrated, as was the relationship between aminoglycoside ARGs and resistant phenotypes. The lack of effective therapeutic agents to combat resistant pathogens presents a real threat to public health. The combination of aminoglycosides with other antibiotics may provide a novel treatment strategy.</p></div>","PeriodicalId":36178,"journal":{"name":"Biosafety and Health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41780569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 4

Immunologically effective biomaterials-enhanced vaccines against infection of pathogenic microorganisms 抗病原微生物感染的免疫有效生物材料增强疫苗

Biosafety and Health Pub Date : 2023-02-01 DOI: 10.1016/j.bsheal.2022.11.002

Qi Wei , Shixian Liu , Xu Huang , Hua Xin , Jianxun Ding

引用次数: 3

Editorial note to previously published articles 对以前发表的文章的编辑说明

Biosafety and Health Pub Date : 2023-01-01 DOI: 10.1016/j.bsheal.2023.10.004

引用次数: 0

Internet of things (IoT) imbedded point-of-care SARS-CoV-2 testing in the pandemic and post-pandemic era 在大流行和大流行后时代，物联网(IoT)嵌入式SARS-CoV-2即时检测

Biosafety and Health Pub Date : 2022-12-01 DOI: 10.1016/j.bsheal.2022.09.005

Zhaoxi Wang , Simin Liu

{"title":"Internet of things (IoT) imbedded point-of-care SARS-CoV-2 testing in the pandemic and post-pandemic era","authors":"Zhaoxi Wang , Simin Liu","doi":"10.1016/j.bsheal.2022.09.005","DOIUrl":"10.1016/j.bsheal.2022.09.005","url":null,"abstract":"<div><p>The outbreaks of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant in China have revealed a high rate of asymptomatic cases, making isolation and quarantine measures exceedingly difficult. Public health surveillance and intervention measures will require rapid and accurate testing preferably on-site using point-of-care tests (POCTs) technology for SARS-CoV-2 variants. However, delayed and/or inaccurate surveillance data is a major obstacle blocking the large-scale implementation of POCTs in curbing spread of infectious pathogens and reducing mortality during an outbreak. To determine levels of community transmission and timely strategies accordingly, highly sensitive and specific POCT embedded with the internet of things (IoT) technology could enable on-site screening and real-time data collection. A new Rapid Amplification with Sensitivity And Portability point-of-care test (RASAP-POCT) system based on thermal convection PCR is the first IoT-based isothermal nucleic acid amplification POCT, which can provide test results within 20–30 min using saliva and/or nasopharyngeal swab samples without nucleic acid extraction. With the IoT-imbedded feature, the RASAP-POCT system can be integrated easily and smoothly with China’s existing mobile-phone-based contact tracing system, which has previously proved to be highly effective in maintaining the dynamic zero-COVID policy. Current regulatory guidelines and rules should be modified to accelerate the adoption of new technologies under an emergency use authorization (EUA).</p></div>","PeriodicalId":36178,"journal":{"name":"Biosafety and Health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10770761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Access and benefit-sharing of the pathogenic microorganisms such as SARS-CoV-2 SARS-CoV-2等病原微生物的获取和惠益分享

Biosafety and Health Pub Date : 2022-12-01 DOI: 10.1016/j.bsheal.2022.05.003

Yalin Zhai , Geng Hong , Mengnan Jiang , Qiang Wei

引用次数: 0

Integrating research infrastructures into infectious diseases surveillance operations: Focus on biobanks 将研究基础设施纳入传染病监测行动:重点放在生物库上

Biosafety and Health Pub Date : 2022-12-01 DOI: 10.1016/j.bsheal.2022.10.001

Plebeian B. Medina , Jennifer Kealy , Zisis Kozlakidis

{"title":"Integrating research infrastructures into infectious diseases surveillance operations: Focus on biobanks","authors":"Plebeian B. Medina , Jennifer Kealy , Zisis Kozlakidis","doi":"10.1016/j.bsheal.2022.10.001","DOIUrl":"10.1016/j.bsheal.2022.10.001","url":null,"abstract":"<div><p>Technological advances in the first two decades of the 21<sup>st</sup> century have profoundly impacted medical research in many ways, with large population cohorts, biological sample collections and datasets through biobanks becoming valued global resources to guide biomedical research, drug development, and medical practice. However, in order for biobanks to maximize their impact and scientific reach of their resources, they would need to act within a complex network of infrastructures and activities. Therefore, different ways have emerged in which biobanks, including those for infectious diseases, can emerge as (part of) infrastructures, integrate within existing ones, or become an independent, yet an interoperable component of the existing infrastructural landscape. However, there has been a limited understanding and study of such mechanisms to date. This perspective aims to address this knowledge gap and illustrates these three high-level ways in which such infrastructures could integrate their activities and identifies the necessary key pre-conditions for doing so, while drawing from specific examples.</p></div>","PeriodicalId":36178,"journal":{"name":"Biosafety and Health","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9750893/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10750779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0