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Background: Point-of-care testing (POCT) is increasingly being used in healthcare, including hospitals, and POCT-style tests are also used within some laboratories. The principles of biosafety, including risk assessment and containment of biohazardous agents, can be utilized as a foundation to establish policies and procedures guiding safe performance of POCT. However, specific biosafety guidelines for POCT are generally lacking, particularly for those performed outside laboratories by healthcare workers. This study aims to explore POCT biosafety program decision-making infrastructure and oversight in Ontario., Content: The Institute of Quality Management in Healthcare distributed a survey to 249 laboratories in Ontario. There were 11 questions on POCT biosafety practices., Summary: The survey had a high response rate of 88.7%. How POCT biosafety decisions were made was variable among respondents. For POCT-style tests conducted within laboratories, the biosafety officer (BSO) and/or the microbiologist were involved in biosafety decisions in 95% of microbiology labs or 55% of other labs. Only 27% of the respondents reported that biosafety decisions were made by BSOs and/or microbiologists when POCT was conducted outside the laboratory. When POCT is performed outside the laboratory, biosafety decisions were made largely by Infection Prevention and Control (IPAC) and POCT laboratory staff. Similarly, training and auditing of staff who perform POCT were mainly done by IPAC and POCT laboratory staff. The survey showed that a wide variety of POCT was being conducted for COVID-19 patients during the pandemic., (© Association for Diagnostics & Laboratory Medicine 2024.)

Objective: This study examines biosafety management practices in a psychiatric hospital's laboratory in China, focusing on how outdated information technology impacts the hospital's ability to respond to public health emergencies. The goal is to enhance the hospital's emergency response capabilities by updating risk assessments, biosafety manuals, and implementing a comprehensive quality management system alongside a specialized infection control system for significant respiratory diseases., Methods: We utilized an integrated research approach, expanding the scope of risk assessments, updating the biosafety manual according to the latest international standards, and implementing a quality management system. A specialized infection control system for significant respiratory diseases was introduced to improve emergency response capabilities., Results: Updated risk assessments and a new biosafety manual have significantly improved the identification and management of biosafety threats. Implementing new quality management and infection control systems has enhanced response efficiency and operational standardization., Conclusion: The measures taken have strengthened the biosafety management and emergency response capabilities of the laboratory department, highlighting the importance of information technology in biosafety management and recommending similar strategies for other institutions., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Tang, Yan, Yuan, Tang, Chen, Sun, Yang and Song.)

Background: The COVID-19 pandemic underscored the critical importance of biosafety in microbiology laboratories worldwide. In response, China has ramped up its efforts to enhance biosafety measures within its Centers for Disease Control and Prevention (CDC) laboratories. This study provides the first comprehensive assessment of biosafety practices across provincial, city, and county levels of CDC microbiology laboratories in China., Methods: We conducted a nationwide cross-sectional survey from 2021 to 2023, targeting staff from microbiology laboratories within CDCs at all administrative levels in China. Stratified sampling was employed to select respondents, ensuring a representative mix across different CDC hierarchies, job titles, and academic qualifications. The survey encompassed questions on biosafety training, the presence of BSL-2 and BSL-3 laboratories, adherence to general biosafety guidelines, and management practices regarding specimens, reagents, and consumables. Statistical analysis was performed to identify significant differences in biosafety practices among different CDC levels., Results: A total of 990 valid responses were received, highlighting a nearly universal presence (98.69%) of BSL-2 laboratories and a significant yet varied presence of BSL-3 laboratories across the CDC network. The survey revealed high levels of biosafety training (98.69%) and adherence to biosafety protocols. However, challenges remain in the consistent application of certain safety practices, especially at lower administrative levels. Notable differences in the management of specimens, reagents, and consumables point to areas for improvement in ensuring biosecurity., Conclusion: Our findings indicate a robust foundation of biosafety practices within CDC microbiology laboratories in China, reflecting significant advancements in the wake of the Biosecurity Law's implementation. Nevertheless, the variability in adherence to specific protocols underscores the need for ongoing training, resources allocation, and policy refinement to enhance biosafety standards uniformly across all levels. This study's insights are crucial for guiding future improvements in laboratory biosafety, not just in China but potentially in other countries enhancing their public health infrastructures., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Niu, Sun, Zhang, Zhao, Tian, Cheng, Zheng, Guo, Zhang, Ma and Wang.)

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.

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.

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., Competing Interests: No Conflict of Interest is declared, (Copyright (c) 2021 SM Rashed Ul Islam, Tahmina Akther, Sharmin Sultana, Paroma Deb, Asish Kumar Ghosh, Md. Abdullah Omar Nasif, Amirul Huda Bhuiyan, Munira Jahan, Afzalun Nessa, Saif Ullah Munshi, Shahina Tabassum.)

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., (© 2021 International Society for Advancement of Cytometry.)

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., (Copyright © 2020 Elsevier B.V. All rights reserved.)

Up to now, Italy is one of the European centers with the most active Coronavirus cases with 233,836 positive cases and 33,601 total deaths as of June 3rd. During this pandemic and dramatic emergency, Italian hospitals had also to face neoplastic pathologies, that still afflict the Italian population, requiring urgent surgical and oncological treatment. In our Cancer Center Hospital, the high volume of surgical procedures have demanded an equally high volume of intraoperative pathological examinations, but also posed an additional major challenge for the safety of the staff involved. The current commentary reports our experience in the past two months (since March 9th) for a total of 1271 frozen exams from 893 suspect COVID-19 patients (31 confirmed)., (Copyright © 2020 Società Italiana di Anatomia Patologica e Citopatologia Diagnostica, Divisione Italiana della International Academy of Pathology.)

Talimogene laherparepvec (T-VEC) is the first agent approved for cancer in the emerging class of oncolytic viral therapies. While T-VEC was approved for the treatment of advanced melanoma in 2015, clinical utilization has been hampered by rapid changes in the therapeutic landscape of melanoma related to advances in both immune checkpoint blockade and targeted therapy, cumbersome logistics involved in T-VEC administration, biosafety concerns, and a perception that T-VEC has limited impact on uninjected, visceral disease. However, with further survival follow-up from the phase III OPTiM (Oncovex GM-CSF Pivotal Trial in Melanoma), along with new real-world data and consensus guidelines on safe administration of oncolytic viruses, a roadmap for when and how to use T-VEC has been emerging. In addition, preliminary data have demonstrated improved therapeutic responses to T-VEC in combination with immune checkpoint blockade in patients with melanoma without additive toxicity. This review provides an update on recent data with T-VEC alone and in combination with other agents. The emerging data provide guidance for how to better utilize T-VEC for patients with melanoma and identifies critical areas for clinical investigation to expand the role of T-VEC in combination strategies for the treatment of melanoma and perhaps other cancers.

Background: Coronavirus disease 2019 is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and represents the causative agent of a potentially fatal disease. The spread of the infection and the severe clinical disease have led to the widespread adoption of social distancing measures. Special attention and efforts to protect or reduce transmission have been applied at all social levels, including health care operators. Hence, this reports focuses on the description of a new protocol for the safe management of cytological samples processed by liquid-based cytology (LBC) with an evaluation of the changes in terms of morphology and immunoreactivity., Methods: From March 11 to April 25, 2020, 414 cytological cases suspicious for SARS-CoV-2 were processed with a new virus-inactivating method suggested by Hologic, Inc, for all LBC specimens., Results: The samples showed an increased amount of fibrin in the background. A slight decrease in cellular size was also observed in comparison with the standard method of preparation. Nonetheless, the nuclear details of the neoplastic cells were well identified, and the immunoreactivity of the majority of those cells was maintained. The cell blocks did not show significant differences in morphology, immunoreactivity, or nucleic acid stability., Conclusions: Despite some minor changes in the morphology of the cells, the results of this study highlight that the adoption of the new protocol for the biosafety of LBC-processed samples in pathology laboratories is important for minimizing the risk for personnel, trainees, and cytopathologists without impairing the diagnostic efficacy of the technique., (© 2020 American Cancer Society.)

The Federal Select Agent Program dictates that all research entities in the United States must rigorously assess laboratory protocols to sterilize samples being removed from containment areas. We validated procedures using sterile filtration and methanol to remove the following select agents: Francisella tularensis, Burkholderia pseudomallei, B. mallei, Yersinia pestis, and Bacillus anthracis. We validated methanol treatment for B. pseudomallei. These validations reaffirm safety protocols that enable researchers to keep samples sufficiently intact when samples are transferred between laboratories.

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., Competing Interests: The authors declare no competing interests., (Copyright: Elizeus Rutebemberwa et al.)

Biosafety is an important guarantee of the new coronavirus laboratory test. The accident treatment of sample overflow and sprinkle is a necessary part of the emergency plan for testing activities. Beijing Preventive Medicine Association coordinated biosafety experts of COVID-19 laboratories from Beijing CDC, to write up "The standard for handling of accidents of corona virus disease 2019 sample (T/BPMA 0005-2020)" . The group standard was based on the guidelines of China and WHO, and combined with the practical experience of COVID-19 epidemic and the principle of "scientific, normative, applicable and feasible" . Through all kinds of risk Assessment, it included the spillover of samples caused by the packing of COVID-19 (highly pathogenic) samples, the overflow and sprinkle in the laboratory during the detection operation, and the spillage accident occurred during the transfer of samples in the same building. The standard could guide and standardize the handling methods of accidental overflow and sprinkle that may occur in the SARS-CoV-2 testing laboratories in the city.

As a result of the 2019 novel human coronavirus (COVID-19) global spread, medical examiner/coroner offices will inevitably encounter increased numbers of COVID-19-infected decedents at autopsy. While in some cases a history of fever and/or respiratory distress (eg, cough or shortness of breath) may suggest the diagnosis, epidemiologic studies indicate that the majority of individuals infected with COVID-19 develop mild to no symptoms. Those dying with-but not of-COVID-19 may still be infectious, however. While multiple guidelines have been issued regarding autopsy protocol in cases of suspected COVID-19 deaths, there is some variability in the recommendations. Additionally, limited recommendations to date have been issued regarding scene investigative protocol, and there is a paucity of publications characterizing COVID-19 postmortem gross and histologic findings. A case of sudden unexpected death due to COVID-19 is presented as a means of illustrating common autopsy findings, as well as diagnostic and biosafety considerations. We also review and summarize the current COVID-19 literature in an effort to provide practical evidence-based biosafety guidance for medical examiner-coroner offices encountering COVID-19 at autopsy.

Europe-wide activities to improve biosafety and biosecurity performed within the frameworks of the European Union (EU)-funded Joint Actions EMERGE and QUANDHIP led to the development of an Integrated European Checklist for Laboratory Biorisk Management (ECL).To better understand different approaches shaping biorisk management (BRM) systems on an operational level in high containment laboratories, the ECL was used to map the implementation of BRM in 32 high containment laboratories in 18 countries in Europe. The results suggest that the BRM elements referring to standard microbiological working practices and the handling of infectious material were fulfilled particularly well. The elements safety exercises involving internal and external emergency responders, and appropriate decommissioning plans were not fulfilled particularly well. BRM in Biosafety Level (BSL) 4 laboratories handling Risk Group (RG) 4 viruses appear to vary among each other less than BSL3 laboratories handling RG 3 bacteria. It is important to agree on comparable regulations in Europe as high containment laboratories are indispensable for a safe, quick and effective response to public health threats. As high containment laboratories may also present a public health risk it is crucial to have robust BRM on organisational and operational levels.

Standard precautions to minimize the risk of SARS-CoV-2 transmission implies that infected cell cultures and clinical specimens may undergo some sort of inactivation to reduce or abolish infectivity. We evaluated three heat inactivation protocols (56 °C-30 min, 60 °C-60 min and 92 °C-15 min) on SARS-CoV-2 using (i) infected cell culture supernatant, (ii) virus-spiked human sera (iii) and nasopharyngeal samples according to the recommendations of the European norm NF EN 14476-A2. Regardless of the protocol and the type of samples, a 4 Log 10 TCID50 reduction was observed. However, samples containing viral loads > 6 Log 10 TCID 50 were still infectious after 56 °C-30 min and 60 °C-60 min, although infectivity was < 10 TCID 50 . The protocols 56 °C-30 min and 60 °C-60 min had little influence on the RNA copies detection, whereas 92 °C-15 min drastically reduced the limit of detection, which suggests that this protocol should be avoided for inactivation ahead of molecular diagnostics. Lastly, 56 °C-30 min treatment of serum specimens had a negligible influence on the results of IgG detection using a commercial ELISA test, whereas a drastic decrease in neutralizing titers was observed.

Purpose: Disturbances that affect the inside of the eyeball tend to be highly harmful since they compromise the homeostasis of this organ. Alongside this, the eyeball has several anatomical barriers that prevent the entry of substances. This way, diseases that affect the retina are among those that present greater difficulty in the treatment. In many cases, abnormal proliferation of blood vessels (neovascularization) occurs from the lower layers of the retina. This process damages its structure physiologically and anatomically, causing the rapid and irreversible loss of visual capacity. This work aims to develop nanosuspensions of quantum dots (QDs) conjugated to bevacizumab. Methods: Two types of QDs were produced by aqueous route, stabilized with chitosan conjugated to bevacizumab. The antiangiogenic activity was evaluated in the chorioallantoic membrane model, in which results indicated discrete activity at the doses tested. Samples were assessed for their biosafety in animals, after intravitreal administration, by means of electroretinography (ERG), intraocular pressure (IOP) measurement, histological, morphometric, and immunohistochemical evaluation. Results: No significant alterations were detected in ERG that suggests damage to retinal function by the samples. No significant changes in IOP were also detected. The histological sections did not show signs of acute inflammation, although there was evidence of late retinal damage. The immunohistochemical analysis did not detect any apoptotic bodies. Conclusion: Preliminary results suggest that QDs present potential applicability in ocular therapy, and it is necessary to better characterize their in vivo behavior and to optimize their dosage.

The fast-paced field of synthetic biology is fundamentally changing the global biosecurity framework. Current biosecurity regulations and strategies are based on previous governance paradigms for pathogen-oriented security, recombinant DNA research, and broader concerns related to genetically modified organisms (GMOs). Many scholarly discussions and biosecurity practitioners are therefore concerned that synthetic biology outpaces established biosafety and biosecurity measures to prevent deliberate and malicious or inadvertent and accidental misuse of synthetic biology's processes or products. This commentary proposes three strategies to improve biosecurity: Security must be treated as an investment in the future applicability of the technology; social scientists and policy makers should be engaged early in technology development and forecasting; and coordination among global stakeholders is necessary to ensure acceptable levels of risk., (© 2020 The Authors. Published under the terms of the CC BY 4.0 license.)

Medical laboratory personnel may be exposed to various hazards, especially biological and chemical, during their routine activities. In this multicenter study, which could reflect the nation wide results, it was aimed to determine the safety and biosecurity practices of the employee working in medical microbiology laboratories and to reveal the current situation. A total of 1072 personnel working in the Medical Microbiology Laboratory of 23 hospitals (14 medical faculty hospitals, seven ministry of health training and research hospitals and two state hospitals) from different provinces were provided with a questionnaire consisting of 33 questions inquiring about the rules, opinions, attitudes and behaviors regarding safety and biosafety practices. Statistical analyses were made with institutions, age groups, gender, educational background, working time and occupational groups in terms of exposure to biological and chemical hazards. It was determined that approximately 50% personnel of the university/ training and research hospitals and 2/3 of the state hospitals personnel consumed food and beverages in the laboratories (p<0.05). Compared with other hospitals, it was determined that in state hospitals; the absence of separate resting room (35%), the personnel finding their own knowledge and practices inadequate (28.9%), laboratory coats washed at home (95%), educational organization and participation rates (90%) and medical waste information levels of the personnel were higher (p< 0.05). It was determined that as the age progresses, the rate of education, food and beverage consumption in the laboratory, not being outside the laboratory with protective equipment (gloves, masks and laboratory coats) and the history of laboratory acquired infections were increased (p< 0.05). It was observed that washing the laboratory coats at home was higher in the younger age group and hospital washing was higher in the elderly group (p< 0.05). There was no significant difference between the genders in terms of food and beverage consumption in the laboratory (p= 0.09). It was determined that periodic health checks were not performed in 1/3 of both sexes, but the use of gloves and compliance with medical waste rules was lower in men. Female employees find themselves inefficient in terms of knowledge and practices (p< 0.05). The rate of those who did not have their periodic checkups at regular intervals was higher in the high school and master of science education groups; While non-compliance with medical waste rules, food and beverage consumption in the laboratory was highest in the primary and high school graduates, the lowest rates were found in the master and doctorate groups (p< 0.05). The rate of those who had regular health checkups was higher in the group of specialist physicians and technicians (p< 0.05). It was observed that the rule of not going out of the laboratory with protective equipment was fully observed in the 35+ years working group, while compliance was 70-85% in other groups (p< 0.05), hepatitis B vaccination rate was highest in specialist doctors and lowest in cleaning and other personnel group (p< 0.05). Highest non-compliance rate with medical waste rules was observed in the cleaning personnel group (p< 0.05). As a result, although advances have been made in employee safety practices in medical microbiology laboratories in our country in recent years, it has been found that it is not yet sufficient. The results indirectly reflected the profile of medical laboratories in our country. In the laboratories, physical space and equipment deficiencies should be eliminated, periodic health checkups and vaccination should be provided, non-staff entrance to the laboratory and food, beverage and cigarette consumption should be prevented, laboratory coats should be washed in the hospital, in-service trainings, including medical waste training, should be conducted and these trainings should be developed through mechanisms that will change the behavior.

Clinical samples collected in coronavirus disease 19 (COVID-19), patients are commonly manipulated in biosafety level 2 laboratories for molecular diagnostic purposes. Here, we tested French norm NF-EN-14476+A2 derived from European standard EN-14885 to assess the risk of manipulating infectious viruses prior to RNA extraction. SARS-CoV-2 cell-culture supernatant and nasopharyngeal samples (virus-spiked samples and clinical samples collected in COVID-19 patients) were used to measure the reduction of infectivity after 10 minute contact with lysis buffer containing various detergents and chaotropic agents. A total of thirteen protocols were evaluated. Two commercially available formulations showed the ability to reduce infectivity by at least 6 log 10, whereas others proved less effective.

The 2019 Coronavirus epidemic, provisionally called 2019-nCoV, was first identified in Wuhan, China, in persons exposed to a seafood or wet market. There is an international push to contain the virus and prevent its spread. It is feasible that potentially infectious samples may be received in histopathology laboratories for diagnosis. This technical note presents disinfection procedures and histotechnology processes that should alleviate the risk of infection to laboratory staff. Using data obtained from similar coronaviruses, e.g. severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS), experts are confident that 70% ethanol and 0.1% sodium hypochlorite should inactivate the virus. Formalin fixation and heating samples to 56oC, as used in routine tissue processing, were found to inactivate several coronaviruses and it is believed that 2019-nCoV would be similarly affected.

Coronavirus disease 2019 (COVID-19) is a grade B infectious disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). In pace with the spreading of the disease, biosafety risk of the biological specimen preservation in biobanks has been significantly increased and biosafety protection during biological specimen preservation become increasingly important. According to the related national rules and the corresponding guidelines of Chinese Medical Association, this paper introduced the etiology about SARS-CoV-2, epidemiology about COVID-19, and the biosafety protection principles of individuals and biological specimen storage places in the process of personal protection, protection of collection, transport, handling, preservation, detection, post-detection disposal and emergencies of biological specimen. Emphasized to carry out a strict biosafety-risk assessment on biological specimen basing on virus load information, infectivity, and sample type (possible contact transmission, aerosol transmission, and fecal oral transmission).

The coronavirus disease 2019 (COVID-19) is a pandemic caused by the SARS-CoV-2 virus. The infection has predominantly respiratory transmission and is transmitted through large droplets or aerosols, and less commonly by contact with infected surfaces or fomites. The alarming spread of the infection and the severe clinical disease that it may cause have led to the widespread institution of social distancing measures. Because of repeated exposure to potentially infectious patients and specimens, health care and laboratory personnel are particularly susceptible to contract COVID-19. This review paper provides an assessment of the current state of knowledge about the disease and its pathology, and the potential presence of the virus in cytology specimens. It also discusses the measures that cytology laboratories can take to function during the pandemic, and minimize the risk to their personnel, trainees, and pathologists. In addition, it explores potential means to continue to educate trainees during the COVID-19 pandemic., (Copyright © 2020 American Society of Cytopathology. Published by Elsevier Inc. All rights reserved.)

The 2019 coronavirus pandemic, which started in Wuhan, China, spread around the globe with dramatic and lethal effects. From the initial Chinese epicenter, the European diaspora taxed the resources of several countries and especially those of Italy, which was forced into a complete social and economic shutdown. Infection by droplets contaminating hands and surfaces represents the main vehicle of diffusion of the virus. The common and strong efforts to contain the pandemic have relevant effects on the management of samples from histopathology laboratories. The current commentary reports and focuses on the protocols and guidelines in use at a large tertiary Italian hospital that accordingly are proposed for adoption in Italian laboratories as a potential model for national guidelines for the coronavirus emergency., (© 2020 American Cancer Society.)

COVID-19 poses a great challenge to clinical and diagnostic services around the world. The need of biosafety practices can never be emphasised more than under current circumstances. The four pillars of biosafety namely, leadership, standard operating procedures, personal protective equipment (PPE) and engineering controls must be employed for effective and safe practices in the clinical setting in general and laboratory settings in particular. Risk assessment must be carried out before meeting up the diagnostic challenge for COVID-19 and essential biorisk management measures are required to be taken. In our resource-poor settings, we need to adapt safe but cost-effective and improvised solutions to ensure safe handling of clinical samples from COVID-19 patients in the laboratories. The correct use of PPE and their suitable alternatives are available for selection and use. Disinfection of the lab areas and safe disposal of the clinical samples from such patients is also of paramount importance.

The normal scope of an adequate public health response to released biological material is framed by working with biological vectors with known pathogenicity and virulence. Defining the scope of a response to the release of biological material with unknown pathogenicity and virulence enters into a novel and yet to be framed domain. A current case, in which extraterrestrial samples returned from a location such as Mars, which may harbor life as we know it, requires framing a public health response. An unintentional release of biological material with unknown pathogenicity and virulence may occur when biological containment mechanisms in the Earth-returning transport method are lost. This article raises initial public health and healthcare response questions during a return of extraterrestrial samples to Earth, in the event of its release from biological containment mechanisms: How does the public health community prepare for a response when there is release of samples that may contain potential extraterrestrial organisms from a planetary body or hardy terrestrial organisms surviving a round trip? If a mishap occurs during the return of these samples, what considerations need to be made to confine, decontaminate, and collect material in regions around the mishap? How will the public health community work with relevant government organizations to prepare the general public? The unknowns of exposure, potential extraterrestrial pathogenicity, and decontamination approaches underscore gaps in biopreparedness for this novel case from federal to local levels.

Background: The external quality assessment (EQA) or external quality control is an evaluation conducted by a certified external organization to inquire about the quality of the results provided by a laboratory. The primary role of EQA is to verify the accuracy of laboratory results. This is essential in research because research data should be published in international peer-reviewed journals, and laboratory results must be repeatable. In 2007, the University Clinical Research Center (UCRC's) biosafety level 3 (BSL-3) laboratory joined the EQA program with the College of American Pathologists in acid-fast staining and culture and identification of mycobacteria as per laboratory accreditation preparedness. Thus, after 11 years of participation, the goal of our study was to evaluate the performance of our laboratory during the different interlaboratory surveys., Methods: We conducted a descriptive retrospective study to evaluate the results of UCRC mycobacteriology laboratory from surveys conducted during 2007 and 2017., Results: Of the 22 evaluations, the laboratory had satisfactory (100% of concordance results) in 18 (81.8%) and good (80% of concordance results) in 4 (18.2%). Overall, the laboratory was above the commended/accepted limits of 75%., Conclusion: So far, UCRC's BSL-3 performed well during the first 11 years of survey participation, and efforts should be deployed to maintain this high quality in the preparedness for laboratory accreditation and support to clinical trials., Competing Interests: None

Nanotechnology may offer innovative solutions to overcome the physiological and anatomical barriers that make the diagnosis and treatment of ear diseases an extremely challenging issue. However, despite the solutions provided by nano-applications, the still little-known toxicological behavior of nanomaterials raised scientific concerns regarding their biosafety for treated patients and exposed workers. Therefore, this review provides an overview on recent developments and upcoming opportunities in nanoscale otological applications, and critically assesses possible adverse effects of nanosized compounds on ear structures and hearing functionality. Although such preliminary data do not allow to draw definite strategies for the evaluation of nanomaterial ototoxicity, they can still be useful to improve scientific community and workforce awareness regarding possible nanomaterial adverse effects on ear.

Laboratory-acquired infections (LAIs), an occupational illness, are defined as all infections acquired through laboratory or laboratory-related activities. A report published in 1898 described an LAI resulting from Corynebacterium diphtheriae being transmitted through mouth pipetting. Despite all efforts, LAIs continue, especially in developing countries like Pakistan, which has been fighting to curb many infectious diseases. As reflected in the published literature, the biosafety culture is severely lacking in many laboratories, and there are no data available from Pakistan on LAIs. Our objective was to ascertain the frequency and rate of LAIs in various labs with versatile portfolios in relation to biosafety and biosecurity practices in Karachi. Ours is a descriptive multicenter cross-sectional study conducted in 30 laboratories located in Karachi from November 2017 to April 2018. Data were collected from laboratories including the university hospital labs, research labs, animal labs, and biomedical labs. Out of 30 facilities, half ( n  = 15) were clinical/biomedical laboratories, 16.6% ( n  = 5) were university hospital laboratories, 26.6% ( n  = 8) were R&D laboratories, and 6.6% ( n  = 2) were animal laboratories. Needle stick was found to be the most common injury, followed by animal bite/scratch, cut on mucous membrane, falling of personnel, and burn injury.

The 2014 to 2016 Ebola outbreak response resulted in many lessons learned about biocontainment patient care, leading to enhanced domestic capabilities for highly infectious and hazardous communicable diseases. However, additional opportunities for improvement remain. The article identifies and describes key considerations and challenges for laboratory analysis, clinical management, transportation, and personnel management during the care of patients infected with Ebola or other special pathogens. Dedication to maintaining preparedness enables biocontainment patient care teams to perform at the highest levels of safety and confidence., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Purpose: This study investigates the use of a canopy-connected recirculating class II type A2 biological safety cabinet (BSC) as an alternative to the B2 when preparing volatile, sterile compounded preparations. Selection of the appropriate BSC for processes that use subgram levels of volatile chemicals is difficult due to a lack of quantitative containment evidence by cabinet type. There is a perception that hazardous compounding must be done in a B2 cabinet due to the potential for vapors, and this study seeks to challenge that perception., Methods: In total, 5 tests, 3 prequalification tests and 2 containment capability tests, were conducted on a single cabinet of each type at sterile compounding pharmacies. Prequalification tests were performed to verify that each BSC was operating properly. Each cabinet was certified to NSF-ANSI 49-2016, particle counted per ISO 14644-1:1999, and subjected to a qualitative video smoke study. Once these tests confirmed the expected working conditions, 2 containment capability tests were conducted. The containment testing included tracer gas testing per ASHRAE 110:2016 section 8.1.1 through 8.1.13, and cyclophosphamide sampling during sterile compounding of the drug material., Results: Both cabinets passed all the prequalification tests. During the ASHRAE tracer gas testing the A2 cabinet was able to contain a tracer gas 92% to 160% as effectively as the B2 cabinet depending on the position of the gas ejection. During sterile compounding the airborne cyclophosphamide sampling captured samples of less than 1.0 ng at all locations for both the A2 and B2 cabinets., Conclusion: The data generated from this study demonstrate that use of an A2 for hazardous compounding can provide a comparable level of safety for the environment, users, and product while having less stringent airflow requirements relative to a B2. The simpler requirements for an A2 make them an appealing alternative as they have the potential to reduce the overall operating costs associated with a compounding pharmacy while maintaining safe levels of containment., (© American Society of Health-System Pharmacists 2019. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

In the UK, research on hazard group 4 (HG4) pathogens requires specialised Containment Level 4 (CL4) facilities. These differ from Biosafety Level 4 (BSL4) conditions in that work is conducted in class III microbiological safety cabinets for primary containment instead of using positive pressure suits. This presents unique challenges associated with the physical restrictions of working in a limited space, and prohibits the use of many techniques and specialist equipment. In consequence, detailed studies on the biology of HG4 pathogens and in particular their immunological relationships with the host are understudied in the UK; for example, the majority of immunological assays with which the immune system is interrogated require specialist equipment that is unsuitable for CL4. Multiplexing to simultaneously measure multiple analytes is increasingly being used in immunological studies. This assay is attractive for CL4 work because it reduces the time spent in the laboratory whilst maximising the use of valuable sample volume. The Luminex microsphere approach allows for the determination of many cytokines and chemokines, however, the detection system uses fixed aligned lasers and integrated computer systems which are unsuitable for use at CL4. Therefore, we have developed an approach in which the Luminex assay is conducted within the CL4 laboratory and a formalin-fixation stage is introduced to allow for analysis to be undertaken outside of containment. Quality control preparations allow the assay characteristics to be monitored and analysis of assay performance to be evaluated. Our data demonstrate that Luminex is an applicable tool for use at CL4 and that assays can be run reliably to generate reproducible standardised data across different plates and individual experiments., (Copyright © 2019. Published by Elsevier Inc.)

The number of biosafety evaluation studies of nanoparticles (NPs) using different biological models is increasing with the rapid development of nanotechnology. Thus far, nematode Caenorhabditis elegans (C. elegans), as a complete model organism, has become an important in vivo alternative assay system to assess the risk of NPs, especially at the environmental level. According to results of qualitative and quantitative analyses, it can be concluded that studies of nanoscientific research using C. elegans is persistently growing. However, the comprehensive conclusion and analysis of toxic effects of NPs in C. elegans are limited and chaotic. This review focused on the effects, especially sublethal ones, induced by NPs in C. elegans, including the development, intestinal function, immune response, neuronal function, and reproduction, as well as the underlying mechanisms of NPs causing these effects, including oxidative stress and alterations of several signaling pathways. Furthermore, we presented some factors that influence the toxic effects of NPs in C. elegans. The advantages and limitations of using nematodes in the nanotoxicology study were also discussed. Finally, we predicted that the application of C. elegans to assess long-term impacts of metal oxide NPs in the ecosystem would become a vital part of the nanoscientific research field, which provided an insight for further study., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Working in accordance with biosafety level four practices is highly complex and time-consuming. Therefore, the respective laboratory protocols should be as uniform as possible, simple to perform and straightforward in readout. Here we describe the successful application of a standardized 24-well plate focus assay protocol for the titration of Zaire ebolavirus (two isolates), Marburg virus (three isolates), Lassa virus (two isolates), Crimean Congo hemorrhagic fever virus (one isolate), and tick-borne encephalitis virus (two isolates). Viral titers are determined based on a simple visual readout. The protocol exhibits high precision, with coefficients of variation for interassay variability ranging between 0.05 and 0.21 and those for intraassay variability between 0.08 and 0.23. All reagents required for the test, including primary and secondary antibodies, are commercially available, facilitating the establishment of the protocol in other laboratories., (Copyright © 2018 Elsevier B.V. All rights reserved.)

Research using laboratory animals has been revolutionized by the creation of humanized animal models, which are immunodeficient animals engrafted with human cells, tissues, or organs. These animal models provide the research community a unique and promising opportunity to mimic a wide variety of disease conditions in humans, from infectious disease to cancer. A vast majority of these models are humanized mice like those injected with human CD34+ hematopoietic stem cells and patient-derived xenografts. With this technology comes the need for the animal research enterprise to understand the inherent and potential risks, such as exposure to bloodborne pathogens, associated with the model development and research applications. Here, we review existing humanized animal models and provide recommendations for their safe use based on regulatory framework and literature. A risk assessment program-from handling the human material to its administration to animals and animal housing-is a necessary initial step in mitigating risks associated with the use of humanized animals in research. Ultimately, establishing institutional policies and guidelines to ensure personnel safety is a legal and ethical responsibility of the research institution as part of the occupational health and safety program and overall animal care and use program., (© The Author(s) 2018. Published by Oxford University Press on behalf of the National Academy of Sciences. All rights reserved. For permissions, please email: journals.permissions@oup.com.)