Biosafety assessment of laying hens fed different treatments of black soldier flies (Hermetia illucens) under doxycycline stress.

The black soldier fly (BSF, Hermetia illucens) is a resource insect that can utilize livestock and poultry feces. However, BSFs may also increase the risk of transmission of antibiotic resistance genes (AGRs) that are widespread in livestock and poultry farm environments. Therefore, we aimed to evaluate the biosecurity risks of different BSF treatments in the laying chicken food chain using the "chicken manure-BSF-laying hens" model. Our results indicated that different BSF treatments significantly affected antibiotic residue, ARGs, MGEs, bacterial antibiotic resistance, and bacterial microbial community composition in the food chain of laying hens fed BSFs. These risks can be effectively reduced through starvation treatment and high-temperature grinding treatment. Comprehensive risk assessment analysis revealed that starvation combined with high-temperature milling (Group H) had the greatest effect.

Developing a Selection Framework for Zinc Ion-Based Biomaterial Design: Guided by the Biosafety Assessment of ZIF-8 and ZnO.

In recent years, nanomaterials have gained widespread use in the biomedical field, with ZIF-8 and ZnO emerging as promising candidates due to their remarkable performance in osteogenesis, angiogenesis, and antimicrobial therapy. However, before advancing these nanomaterials for clinical applications, it is imperative to evaluate their biocompatibility. In particular, comparing nanomaterials with similar biomedical functions is crucial for identifying the most suitable nanomaterials for further development and market entry. Our study aimed to compare the biocompatibility of nano-ZIF-8 and nano-ZnO under the same conditions. We found that nano-ZIF-8 exhibited lower toxicity both in vitro and in vivo compared to nano-ZnO. To gain insights into the underlying mechanisms responsible for this difference, we conducted further experiments to investigate lysosome damage, mitochondrial change, and the occurrence of ferroptosis. Additionally, we performed transcriptome sequencing to analyze the expression of relevant genes, thereby providing robust validation for our findings. In summary, our study highlighted the importance of evaluating nanomaterials with similar biomedical effects. Through this comparative study, we have not only shed light on the superior biocompatibility of nano-ZIF-8 over nano-ZnO, but also contributed valuable insights and methodological references for future material screening endeavors. Ultimately, our study served as a stepping stone toward the development of safer and more effective nanomaterials for various biomedical applications.

Genetically engineered eucalyptus expressing pesticidal proteins from Bacillus thuringiensis for insect resistance: a risk assessment evaluation perspective.

Eucalyptus covers approximately 7.5 million hectares in Brazil and serves as the primary woody species cultivated for commercial purposes. However, native insects and invasive pests pose a significant threat to eucalyptus trees, resulting in substantial economic losses and reduced forest productivity. One of the primary lepidopteran pests affecting eucalyptus is Thyrinteina arnobia (Stoll, 1782) (Lepidoptera: Geometridae), commonly referred to as the brown looper caterpillar. To address this issue, FuturaGene, the biotech division of Suzano S.A., has developed an insect-resistant (IR) eucalyptus variety, which expresses Cry pesticidal proteins (Cry1Ab, Cry1Bb, and Cry2Aa), derived from Bacillus thuringiensis (Bt). Following extensive safety assessments, including field trials across various biomes in Brazil, the Brazilian National Technical Commission of Biosafety (CTNBio) recently approved the commercialization of IR eucalyptus. The biosafety assessments involved the analysis of molecular genomics, digestibility, thermostability, non-target organism exposure, degradability in the field, and effects on soil microbial communities and arthropod communities. In addition, in silico studies were conducted to evaluate allergenicity and toxicity. Results from both laboratory and field studies indicated that Bt eucalyptus is as safe as the conventional eucalyptus clone for humans, animals, and the environment, ensuring the secure use of this insect-resistant trait in wood production.

Biosafety and toxicity assessment of transgenic cotton-harboring insecticide and herbicide tolerant genes on albino mice.

Introduction: Genetic engineering has revolutionized agriculture by transforming biotic and abiotic stress-resistance genes in plants. The biosafety of GM crops is a major concern for consumers and regulatory authorities. Methodology: A 14-week biosafety and toxicity analysis of transgenic cotton, containing 5 transgenes ((Cry1Ac, Cry2A, CP4 EPSPS, VIP3Aa, and ASAL)), was conducted on albino mice. Thirty mice were divided into three groups (Conventional, Non-transgenic, without Bt, and transgenic, containing targeted crop) according to the feed given, with 10 mice in each group, with 5 male and 5 female mice in each group. Results: During the study, no biologically significant changes were observed in the non-transgenic and transgenic groups compared to the control group in any of the study's parameters i.e. increase in weight of mice, physiological, pathological, and molecular analysis, irrespective of the gender of the mice. However, a statistically significant change was observed in the hematological parameters of the male mice, while no such change was observed in the female study group mice. The expression analysis, however, of the TNF gene increases many folds in the transgenic group as compared to the non-transgenic and conventional groups. Conclusion: Overall, no physiological, pathological, or molecular toxicity was observed in the mice fed with transgenic feed. Therefore, it can be speculated that the targeted transgenic crop is biologically safe. However, more study is required to confirm the biosafety of the product on the animal by expression profiling.

Pre-clinical safety and toxicity assessment of Limosilactobacillus fermentum NCDC 400 in murine model.

Comprehensive safety assessment of potential probiotic strains is crucial in the selection of risk-free strains for clinical translation. This study aimed to evaluate the biosafety of Limosilactobacillus fermentum NCDC 400, a potential probiotic strain, using oral toxicity tests in a Swiss albino mouse model. Mice were orally gavaged with low (108 CFU/mouse/day) and high (1010 CFU/mouse/day) doses of NCDC 400 for 14 (acute), 28 (subacute), and 90 (subchronic) days to assess behavioral, hematological, biochemical, immunological, and histological effects. The administration of NCDC 400 did not result in any observable adverse effects on general health parameters, including body weight, feed and water intake, and organ indices. Hematological and biochemical parameters, such as glucose, serum enzymes, urea, creatinine, serum minerals, total serum proteins, and lipid profile, remained largely unaffected by the test strain. Notably, NCDC 400 administration led to a significant reduction in harmful intestinal enzymes and improvement in gut health indices, as indicated by fecal pH, lactate, ammonia, and short-chain fatty acids. There were no instances of bacterial translocation of NCDC 400 to blood or extra-intestinal organs. Immune homeostasis was not adversely affected by repeated exposure to NCDC 400 in all three oral toxicity studies. Histopathological examination revealed no strain-related changes in various tissues. Based on these findings, a dose of 1010 CFU/mouse/day was considered as the No Observable Effect Level (NOEL) in healthy mice. In conclusion, this study demonstrates the safe and non-toxic behavior of L. fermentum NCDC 400. The results support and ensure the safety and suitability for clinical trials and eventual translation into clinical practice as potential probiotic.

GMOCU: Digital Documentation, Management, and Biological Risk Assessment of Genetic Parts.

The continuous evolution of molecular biology and gene synthesis methods paired with an ever-increasing potential of synthetic biology approaches and genome engineering toolkits enables the rapid design of genetic bioparts and genetically modified organisms. Although various software solutions assist with specific design tasks and challenges, lab internal documentation and ensuring compliance with governmental regulations on biosafety assessment of the generated organisms remain the responsibility of individual academic researchers. This results in inconsistent and redundant documentation regimes and a significant time and labor burden. GMOCU (GMO documentation) is a standardized semi-automatic user-oriented software approach -written in Python and freely available- that unifies lab internal data documentation on genetic parts and genetically modified organisms (GMOs). It automatizes biological risk evaluations and maintains a shared up-to-date inventory of bioparts for team-wide data navigation and sharing. GMOCU further enables data export into customizable formats suitable for scientific publications, official biosafety documents, and the research community.

Green Synthesis and Biosafety Assessment of MXene.

The rise of MXene-based materials with fascinating physical and chemical properties has attracted wide attention in the field of biomedicine, because it can be exploited to regulate a variety of biological processes. The biomedical applications of MXene are still in its infancy, nevertheless, the comprehensive evaluation of MXene's biosafety is desperately needed. In this review, the composition and the synthetic methods of MXene materials are first introduced from the view of biosafety. The evaluation of the interaction between MXene and cells, as well as the safety of different forms of MXene applied in vivo are then discussed. This review provides a basic understanding of MXene biosafety and may bring new inspirations to the future applications of MXene-based materials in biomedicine.

Implantable Flexible Sensors for Health Monitoring.

Flexible sensors, as a significant component of flexible electronics, have attracted great interest the realms of human-computer interaction and health monitoring due to their high conformability, adjustable sensitivity, and excellent durability. In comparison to wearable sensor-based in vitro health monitoring, the use of implantable flexible sensors (IFSs) for in vivo health monitoring offers more accurate and reliable vital sign information due to their ability to adapt and directly integrate with human tissue. IFSs show tremendous promise in the field of health monitoring, with unique advantages such as robust signal reading capabilities, lightweight design, flexibility, and biocompatibility. Herein, a review of IFSs for vital signs monitoring is detailly provided, highlighting the essential conditions for in vivo applications. As the prerequisites of IFSs, the stretchability and wireless self-powered properties of the sensor are discussed, with a special attention paid to the sensing materials which can maintain prominent biosafety (i.e., biocompatibility, biodegradability, bioresorbability). Furthermore, the applications of IFSs monitoring various parts of the body are described in detail, with a summary in brain monitoring, eye monitoring, and blood monitoring. Finally, the challenges as well as opportunities in the development of next-generation IFSs are presented.

Exploration of risk analysis and elimination methods for a Cr(VI)-removal recombinant strain through a biosafety assessment in mice.

Though recombinant strains are increasingly recognized for their potential in heavy metal remediation, few studies have evaluated their safety. Moreover, biosafety assessments of fecal-oral pathway exposure at country as well as global level have seldom analyzed the health risks of exposure to microorganisms from a microscopic perspective. The present study aimed to predict the long-term toxic effects of recombinant strains by conducting a subacute toxicity test on the chromium-removal recombinant strain 3458 and analyzing the gut microbiome. The available disinfection methods were also evaluated. The results showed that strain 3458 induced liver damage and affected renal function and lipid metabolism at 1.0 × 1011 CFU/mL, which may be induced by its carrier strain, pET-28a. Strain 3458 poses the risk of increasing the number of pathogenic bacteria under prolonged exposure. When 500 mg L-1 chlorine-containing disinfectant or 250 mg L-1 chlorine dioxide disinfectant was added for 30 min, the sterilization rate exceeded 99.9 %. These findings suggest that existing wastewater disinfection methods can effectively sterilize strain 3458, ensuring its application value. The present study can serve a reference for the biosafety evaluation of the recombinant strain through exposure to the digestive tract and its feasibility for application in environmental pollution remediation.

Environmental Health and Safety Offers a Biosafety Risk Assessment for a Theoretical Model of a Gene Therapy Process Transfer from Research and Development to Large-Scale Manufacturing.

Introduction: This article provides a strategy by which a manufacturing process with a Biosafety Level 2 (BL2) designation can be downgraded to Biosafety Level 1 (BL1). The principles of the downgrading process are based on the robust contamination controls in clinical and commercial manufacturing, which typically are not part of Research and Development processes. These strict requirements along with the application of current Good Manufacturing Practice (cGMP) principles provide a framework by which processes can be suitably managed and controlled to mitigate biohazard risk, specifically for cell lines that may be contaminated with human pathogenic viral agents. Purpose: We demonstrate how a risk assessment guide was used to define the risk profile of a theoretical process with a human cell line intended for clinical/commercial application. Based on the risk assessment, key BL2 elements were identified as suitable for downgrading, including facility containment controls, emergency spill response plans, and storage and shipping requirements. For various reasons, some aspects of the systems were deemed unsuitable for downgrading due to the severity of the control risk and, therefore, remained at BL2. Summary and Conclusions: We have used an established risk assessment guide to show how cGMP compliments and augments biosafety containment. We provide justification for downgrading from BL2 to BL1 for clinical and commercial cell and gene therapy manufacturing with human cell lines.

Oncolytic Viruses: An Inventory of Shedding Data from Clinical Trials and Elements for the Environmental Risk Assessment.

Attenuated and/or genetically modified oncolytic viruses (OV) gain increasing interest as a promising approach for cancer therapy. Beside the assessment of subject safety, quality and efficacy aspects of medicinal products for human use, genetically modified viruses are also governed by EU regulatory frameworks requiring an environmental risk assessment (ERA). An important element to be assessed as part of the ERA is the incidence of exposure to OV of individuals, other than the trial subjects, and the environment. The evidence-based evaluation of shedding data is considered to be decisive in that context, as it may impact the OV capacity to be transmitted. This is particularly true for OV still able to (conditionally) replicate as opposed to replication-defective viral vectors commonly used in gene therapy or vaccination. To our knowledge, this article presents the most extensive and up-to-date review of shedding data reported with OV employed in clinics. Besides the identification of a topical need for improving the collection of shedding data, this article aims at providing an aid to the design of an appropriate shedding study, thereby relying on and further complementing principles described in existing guidelines issued by European and international institutions.

Risk assessment and bioburden evaluation of Agrobacterium tumefaciens-mediated transient protein expression in plants using the CaMV35S promoter.

Large-scale transient expression of recombinant proteins in plants is increasingly used and requires the multi-liter cultivation of Agrobacterium tumefaciens transformed with an expression vector, which is often cloned in Escherichia coli first. Depending on the promoter, unintentional activity can occur in both bacteria, which could pose a safety risk to the environment and operators if the protein is toxic. To assess the risk associated with transient expression, we first tested expression vectors containing the CaMV35S promoter known to be active in plants and bacteria, along with controls to measure the accumulation of the corresponding recombinant proteins. We found that, in both bacteria, even the stable model protein DsRed accumulated at levels near the detection limit of the sandwich ELISA (3.8 µg L-1). Higher levels were detected in short cultivations (< 12 h) but never exceeded 10 µg L-1. We determined the abundance of A. tumefaciens throughout the process, including infiltration. We detected few bacteria in the clarified extract and found none after blanching. Finally, we combined protein accumulation and bacterial abundance data with the known effects of toxic proteins to estimate critical exposures for operators. We found that unintended toxin production in bacteria is negligible. Furthermore, the intravenous uptake of multiple milliliters of fermentation broth or infiltration suspension would be required to reach acute toxicity even when handling the most toxic products (LD50 ~ 1 ng kg-1). The unintentional uptake of such quantities is unlikely and we therefore regard transient expression as safe in terms of the bacterial handling procedure.

An assessment of the highly pathogenic avian influenza resurgence at human-poultry-environment interface in North-central Nigeria: Sociocultural determinants and One Health implications.

Highly pathogenic avian influenza H5N1 resurgence has occurred in Nigerian domestic bird flocks with public health concern. This study assessed poultry farmers' knowledge, perceptions, and biosecurity and biosafety practices regarding H5N1 resurgence, explore risk pathways for viral dissemination and associated socio-cultural and economic drivers in poultry flocks in Nigeria. A cross-sectional survey was carried out in randomly selected two poultry production systems, commercial intensive poultry production system and the backyard traditional free-range poultry production system. A One Health framework model was conceptualized to assess inter-links of biophysical, environmental, and sociocultural activities that interface to drive resurgence for better interventions. Descriptive and analytical statistical analyses were performed at 95% confidence level. Of the 422 recruited poultry farmers, 98.6% (n = 416) participated. Majorities of smallholder commercial farmers (93.5%) and backyard poultry keepers (97.7%) engaged in intensive and extensive management, respectively. Identified significant zoonotic risk pathways for H5N1 virus spread were through consumption of undercooked poultry meat and products, and contacts with infected birds and contaminated fomites. Separation of sick birds from apparently healthy ones, frequent cleaning and disinfection of equipment and premises, movement control of birds to nearby water bodies, use of personal protective equipment, and movement control of persons and vehicles into the flock settlements were significantly practiced biosecurity measures. Presence of nearby water bodies (ponds) close to flock settlements (p < 0.001), frequent contact of wild and domestic birds (p < 0.001), cultural practice of bird exchange between flocks (p < 0.001), and wild waterfowls' seasonal migrations (p < 0.001) significantly influenced resurgence. Understanding determinants interactions in the 'Conceptual One Health framework model' is required for better intercontinental intervention against HPAI H5N1. Reform of socio-cultural and economic activities using One Health approach will not only assure food safety and food security, but also guarantee public and environmental health.

Recommendations for the Assessment of Potential Environmental Effects of Genome-Editing Applications in Plants in the EU.

The current initiative of the European Commission (EC) concerning plants produced using certain new genomic techniques, in particular, targeted mutagenesis and cisgenesis, underlines that a high level of protection for human and animal health and the environment needs to be maintained when using such applications. The current EU biosafety regulation framework ensures a high level of protection with a mandatory environmental risk assessment (ERA) of genetically modified (GM) products prior to the authorization of individual GMOs for environmental release or marketing. However, the guidance available from the European Food Safety Authority (EFSA) for conducting such an ERA is not specific enough regarding the techniques under discussion and needs to be further developed to support the policy goals towards ERA, i.e., a case-by-case assessment approach proportionate to the respective risks, currently put forward by the EC. This review identifies important elements for the case-by-case approach for the ERA that need to be taken into account in the framework for a risk-oriented regulatory approach. We also discuss that the comparison of genome-edited plants with plants developed using conventional breeding methods should be conducted at the level of a scientific case-by-case assessment of individual applications rather than at a general, technology-based level. Our considerations aim to support the development of further specific guidance for the ERA of genome-edited plants.

Insecticidal efficacy and risk assessment of different neuropeptide analog combinations against the peach-potato aphid following topical exposure.

BACKGROUND: Insect neuropeptides control essential physiological metabolic activities. In our previous studies, Capability/CAP2b (PK/CAPA) analog 1895 applied alone or as a combination of CAPA analogs (1895 + 2315) was reported to decrease aphid fitness. While this was obtained with the combination of two peptide analogs of the same neuropeptide class, the effect of combining peptide analogs of different neuropeptide classes has not been explored so far. RESULTS: In this study, we assessed the effect of combinations of the PK/CAPA analog 1895 with neuropeptide analogs of four different classes [adipokinetic hormone (AKH) analog: 2271; myosuppressin analog: 2434; kinin analog: 2460; tachykinin-related peptide analog: 2463] on the fitness of aphids. We found that the combination of 1895 and AKH analog 2271 was the most effective one to control Myzus persicae. The triple combination 1895 + 2271 + 2315 provided a synergistic effect by further increasing aphid mortality and reducing reproduction relative to 1895 + 2315. Additionally, a biosafety assessment of the combination 1895 + 2271 + 2315 showed no significant lethal nor sub-lethal effects on survival rates and food intake for the pollinator (Bombus terrestris) and the two representative natural enemies (Harmonia axyridis and Nasonia vitripennis). CONCLUSION: These results could facilitate establishment of the triple combination 1895 + 2271 + 2315, and/or inclusion of second generation analogs, as alternatives to broad spectrum and less friendly insecticides. © 2022 Society of Chemical Industry.

Safety Assessment of the Potential Probiotic Bacterium Limosilactobacillus fermentum J23 Using the Mexican Fruit Fly (Anastrepha ludens Loew, Diptera: Tephritidae) as a Novel In Vivo Model.

Safety assessment of probiotics is difficult but essential. In this work, the Mexican fruit fly, Anastrepha ludens (Loew) (Diptera: Tephritidae), was used as in vivo model to assess the biosafety of Limosilactobacillus fermentum J23. In the first set of experiments, the strain was orally administered to adult flies through direct feeding, whereas in the second set of experiments, it was supplemented through the larval rearing medium. Data showed that L. fermentum J23 did not lead to increased mortality or treatment-related toxicity signs in adult female and male flies. Ingestion of L. fermentum J23 by adult female flies led to a statistically significant improvement in locomotor activity compared to the control groups (ca. 59% decrease in climbing time, p < 0.0001). A positive trend in lifespan extension under stress (maximum lifespan = 144 h) was also observed. When L. fermentum J23 was administered to the larvae, the adult emergence (p = 0.0099), sex ratio (p = 0.0043), and flight ability (p = 0.0009) increased significantly by 7%, 31%, and 8%, respectively, compared to the control diet. No statistical effect between the control diet and the L. fermentum J23-based diet for the number of pupae recovered, pupal weight, duration of the pupal stage, lifespan under stress, and morphological development was observed. We conclude that feeding L. fermentum J23 to the novel experimental model A. ludens had no toxic effects and could be safely considered a potential probiotic for food supplements; however, further studies are still needed to establish its biosafety in humans.

A Multilingual Tool for Standardized Laboratory Biosafety and Biosecurity Assessment and Monitoring.

Control of infectious diseases requires the handling of infectious materials by both clinical and public health laboratories with exposure risks for laboratory personnel and environment. A comprehensive tool for assessing the capacity to manage these risks could enable the development of action plans for mitigation. Under the framework of the Global Health Security Agenda action package for biosafety and biosecurity, the authors developed a tool dedicated to assessing laboratory biosafety and biosecurity. The Biosafety and Biosecurity Laboratory Assessment Tool (BSS LAT) assesses the status of all laboratory biosafety core requirements across 10 different modules. It consists of a standardized spreadsheet-based tool that provides automatic scoring. It is designed to support national, regional, and global efforts to strengthen biosafety in clinical, public health, and veterinary laboratories. The BSS LAT was first used in Burkina Faso in collaboration with the African Society for Laboratory Medicine and the US Centers for Disease Control and Prevention to support the country in strengthening their biorisk management system. Since then, it has been successfully used in other countries (ie, Armenia, Burundi, Cameroon, Ghana, Guinea, Kazakhstan, Liberia), various settings (medical and veterinary laboratories), and translated into several languages (eg, English, French, Russian). The BSS LAT is a multipurpose tool that assists with standardization of biosafety and biosecurity requirements for all laboratories working with infectious materials, serves as a self-assessment guide for laboratories to develop improvement plans and reinforce capacities, and serves as a training guide for individual laboratories and networks or at the national level. The BSS LAT can also be used as a monitoring tool for the assessment of biosafety and biosecurity across all laboratories working with infectious materials at the national, regional, and global levels.

Construção e validação de instrumento para avaliação das medidas de biossegurança em bioterrorismo pelos bombeiros / Construction and validation of and assessment tool for biosafety measures in bioterrorism for firefighters / Construcción y validación de un instrumento para evaluar las medidas de bioseguridad en el bioterrorismo de los bomberos

Objetivo: Este estudo teve como objetivo desenvolver e validar um instrumento de avaliação das medidas de Biossegurança adotadas pelos bombeiros militares, para a contenção dos agentes biológicos frente a um evento de bioterrorismo. Métodos: Tratou-se de um estudo descritivo de abordagem quantitativa, de desenvolvimento metodológico e do tipo de validação de conteúdo de um instrumento de avaliação. O estudo foi dividido nas fases de desenvolvimento e validação do instrumento. Para o desenvolvimento do instrumento foram feitas revisões da literatura e para a validação do instrumento foi utilizado o método Delphi. Para o estudo foram incluídos 6 juízes que avaliaram o instrumento através da escala numérica tipo Likert. Resultados: Os juízes avaliaram que o instrumento proposto está bem estruturado, possuindo boa clareza e coesão de escrita, com aplicabilidade no campo de estudo e de grande relevância, principalmente em vista a ausência desse tipo de instrumento para a população de bombeiros militares. Para avaliar a concordância entre os juízes foi utilizado o índice de Validade de Conteúdo, que alcançou 98% de concordância e o Índice de Fidedignidade Interavaliadores, que alcançou os conceitos bom e muito bom, mostrando baixa variância das respostas dos juízes, sendo estatisticamente válido. Conclusão: O estudo descreveu o processo de construção e validação do instrumento, provando ser apropriado e confiável para ser utilizado.

Objective: This study aimed to develop and validate an instrument to assess the Biosafety measures adopted by firefighters, for the containment of biological agents in the face of a bioterrorism event. Methods: This is a descriptive study with a quantitative approach, methodological development, and the type of content validation of an assessment instrument. The study was divided into instrument development and validation phases. For the development of the instrument, literature reviews were conducted and for the instrument validation, the Delphi method was used. For the study, 6 judges were included who evaluated the instrument using the Likert-type numerical scale. Results: The judges evaluated that the proposed instrument is well structured, with good clarity and cohesion of writing, with applicability in the field of study and of great relevance, especially considering the absence of this type of instrument for the military firefighter population. To evaluate the agreement between the judges, we used the Content Validity Index which reached 98% of agreement and the Interrate agreement, which reached the concepts good and very good, showing low variance of the judges' answers, being statistically valid. Conclusion: The study described the process of construction and validation of the instrument, proving to be appropriate and reliable to be used.

Objetivo: Este estudio tenía como objetivo desarrollar y validar un instrumento para evaluar las medidas de bioseguridad adoptadas por los bomberos militares para contener los agentes biológicos durante un evento de bioterrorismo. Métodos: Se trata de un estudio descriptivo de abordaje cuantitativo, de desarrollo metodológico y del tipo de validación de contenido de un instrumento de evaluación. El estudio se dividió en las fases de desarrollo y validación del instrumento. Para la elaboración del instrumento se realizaron revisiones bibliográficas y para la validación del mismo se utilizó el método Delphi. Para el estudio se incluyeron 6 jueces que evaluaron el instrumento mediante una escala numérica tipo Likert. Resultados: Los jueces evaluaron que el instrumento propuesto está bien estructurado, poseyendo buena claridad y cohesión de redacción, con aplicabilidad en el campo de estudio y de gran relevancia, especialmente en vista de la ausencia de este tipo de instrumento para la población de bomberos militares. Se utilizó el Índice de Validez de Contenido para evaluar la concordancia entre los jueces, alcanzando un 98% de acuerdo y el Índice de Fiabilidad Inter-registrador, que alcanzó conceptos buenos y muy buenos, mostrando una baja varianza en las respuestas de los jueces, siendo estadísticamente válido. Conclusión: El estudio describió el proceso de construcción y validación del instrumento, demostrando ser apropiado y confiable para ser utilizado.

Assessment of biosafety and implantation feasibility of novel phakic refractive lens.

PURPOSE: We investigated the biosafety and implantation feasibility of a new phakic refractive lens (PRL) in rabbit eyes. METHODS: Short PRLs (S-PRLs), large PRLs (L-PRLs), and large-grooved PRLs (LG-PRLs), were prepared by molding medical-grade liquid silicon. The cytotoxicity and cellular adhesion of the PRLs was assessed in vitro. To assess implantation feasibility, the S-PRL, L-PRL, and LG-PRL were implanted in the posterior chamber of rabbit eyes and the relative position was assessed by optical coherence tomography. The intraocular pressures (IOP) were compared between the S-PRL, L-PRL, LG-PRL, and control groups to evaluate the PRL biosafety after implantation. RESULTS: The in vitro assays showed that cell viability and cellular adhesion in the S-PRL, L-PRL and LG-PRL groups was not significantly different to those in the control group throughout the study. After implantation into the posterior chamber of rabbit eyes, there were no obvious signs of inflammation or increases in IOP at each time point relative to the control group, demonstrating good biosafety of the PRL. The relative positions of the L-PRLs and LG-PRLs in the posterior chamber were appropriate and the retention frequencies were high. CONCLUSIONS: The newly developed LG-PRL showed good biosafety with negligible in vitro cytotoxicity, ocular inflammation, or fluctuations in IOP. The LG-PRL provided the best implantation feasibility. The grooves on the LG-PRL provided channels for aqueous humor circulation. The LG-PRL is a promising type of PRL with an appropriate size and surface structure for effective correction of refractive errors in rabbit eyes.