Determining Factors in the Implementation of Biosecurity Measures by Hospital Nurses in Piura, Peru.

Nosocomial infections are a significant cause of morbidity, mortality, and increased treatment costs in hospitals. This study aimed to analyze the factors determining the implementation of biosafety measures by the nursing staff of four hospitals in Piura via a structural equation modeling (SEM) approach. A total of 215 nurses from various hospitals in the region participated by completing an online survey. The results demonstrated that extrinsic factors (FEX) positively influence the implementation of biosafety measures (BIOM) (ß = 0.319 ***), as do intrinsic factors (FINT) (ß = 0.520 **). Furthermore, intrinsic factors mediate the relationship between extrinsic factors and the implementation of biosafety measures (ß = 0.443 ***). In conclusion, this study provides a deeper understanding of biosafety dynamics in healthcare settings and lays the groundwork for the development of customized interventions and ongoing training programs that ensure the optimal implementation of biosafety measures in hospitals.

Whole genome sequence data of ZEN-degrading strain Levilactobacillus brevis PYN10_6_2 isolated from Tenebrio molitor larval feces.

Levilactobacillus brevis PYN10_6_2, a lactic acid bacterial strain previously isolated from Tenebrio molitor larval feces, possesses the ability to convert zearalenone (ZEN) to α-/ß-Zearalenol (α-/ß-ZEL). However, the genes involved in the ZEN reduction reaction and the biosafety of this strain remain unknown. In this study, we sequenced, assembled, and annotated the whole genome of L. brevis PYN10_6_2. Genomic sequencing was conducted using short-read sequencing on the Illumina HiSeq X Ten platform and long-read sequencing on the PacBio RS II Single Molecule Real-Time (SMRT) platform. The assembled genome consisted of one circular chromosome, four circular plasmids, with a total size of 2,745,725 bp and a G + C content of 45.52 %. Annotation identified 2,660 coding sequences, 5 rRNAs, 66 tRNAs, and a single CRISPR locus. Average nucleotide identity (ANI) between L. brevis PYN10_6_2 and L. brevis DSM 20054T yielded a value of 98.94 %. Further in-depth analysis revealed 182 antibiotic resistance genes, 237 putative virulence genes, 2 prophages, and 10 genomic islands. Additionally, functional annotation through COG and KEGG databases revealed the presence of three genes encoding 3α- and 3ß-hydroxysteroid dehydrogenase (3α-/3ß-HSD) within the bacterial chromosome. This comprehensive genomic characterization provides valuable insights into the genetic basis of L. brevis PYN10_6_2's ZEN-reducing ability and its biosafety profile.

Genomic analysis of Brucella isolates from animals and humans, Türkiye, 2010 to 2020.

BackgroundBrucellosis is a bacterial zoonosis causing severe illness in humans and animals and leading to economic losses in the livestock production in Türkiye and other endemic countries.AimWe aimed at investigating genomic differences of Brucella isolates from animals and humans in Türkiye.MethodsWe used whole genome sequencing (WGS) to assess the genetic diversity of Brucella isolates from 41 provinces in Türkiye and compared with isolates from other countries. We applied allele-based typing and core genome single nucleotide polymorphism (cgSNP) determination.ResultsOf the 106 Turkish Brucella isolates included, 57 were B. abortus and 49 were B. melitensis. One B. melitensis and two B. abortus isolates were identified as vaccine strains. Most (n = 55) B. abortus isolates clustered in three major branches, with no spatial discernible pattern. Of the B. melitensis isolates, 48 were assigned to the Eastern Mediterranean lineage with no discernible patterns between host species, location and sampling date. The Turkish isolates clustered with isolates from neighbouring countries such as Greece and Syria, but some also with isolates from human patients in European countries, like Germany, Norway and Sweden, suggesting that the source may be travel-related.ConclusionSeveral B. melitensis and B. abortus lineages are circulating in Türkiye. To decrease the prevalence and prevent brucellosis in animals and humans, stricter control measures are needed, particularly in areas where humans and animals have close contact. Furthermore, illegal transportation of animals across borders should be more closely controlled and regulated.

Exploring the effect of hydroxyapatite nanoparticle shape on red blood cells and blood coagulation.

Aim: In this study, we evaluated the effects of two types of hydroxyapatite (HAP) nanoparticles, sharing the same surface chemistry but differing in shape, on the biological characteristics of plasma, platelets and red blood cells.Materials & methods: Initially, two different shapes (rod-shaped and sphere-shaped) of HAPs were characterized. These HAPs were then co-cultured with plasma and red blood cells to examine their impact on coagulation and hemolysis. The impact of HAPs on white blood cells count in mice were evaluated following gavage and tail vein injection.Results: Sphere-shaped HAP is more likely to adsorb onto platelet surfaces, while rod-shaped HAP is more likely to cause hemolysis. Although there are differences in the in vitro experimental results between sphere-shaped HAP and rod-shaped HAP, both types demonstrate good blood compatibility at a 20 mM concentration. Furthermore, in vivo experiments showed that sphere-shaped nano-HAP induced a more pronounced increase in white blood cell count, suggesting that it may exhibit greater toxicity.Conclusion: While differences exist in the blood compatibility test results between the two HAPs, these differences are minimal, with both results falling within a safe range. Overall, HAP demonstrates excellent blood compatibility.

[Box: see text].

Biotoxicity of silver nanoparticles complicated by the co-existence of micro-/nano-plastics.

Silver nanoparticles (AgNP) and polystyrene (PS) plastics have been broadly utilized in various field, e.g., food storage, packaging materials, and medical therapies. However, investigation on the potential biotoxicity induced by the co-exposure to AgNP and PS plastics remains understudied. Thus, we performed this study to examine the toxicological profile of the co-exposure to AgNP and PS in mice. Biochemical and microbial characterizations were performed in mice receiving 90-day oral gavage feeding to examine the hepatotoxicity, neurotoxicity, inflammatory responses, gut microbial alterations. It has been found that the presence of plastic particles aggravates the toxicity of silver nanoparticle materials. Regardless of the plastic type and size, energy and choline metabolisms will be altered by the co-exposures. Moreover, microplastics may induce cell damage by modulating fatty acid peroxidation in unison with stimulating inflammatory responses. Due to the smaller size of nanoplastics, they may pass through blood-brain barrier to induce neuronal damage and increase vascular risks. Changes in the microbial functional abundances are sensitive to the microplastics doses. These results support the necessity of reducing the co-exposure between AgNP and multiscale plastics, and advocate further developments of biodegradable package materials to improve food safety.

Impact of graded doses of enrofloxacin on the safety and biological responses of Nile tilapia Oreochromis niloticus.

The cultivation of tilapias, the third most farmed fish group globally, has been rapidly growing, especially in Southeast Asia. This surge in tilapia farming intensification has led to increased use of antibiotics to control bacterial diseases. This study investigated the safety implications of administering graded doses of enrofloxacin (ENF) at 0 (control), 10, 30, 50 and 100 mg/kg biomass/day orally to Oreochromis niloticus. The 43-day study comprised 7 days of pre-dosing, 15 days of ENF-dosing, and a 21-day recovery period with a periodical assessment of the biological responses of fish. The results revealed that the overdosed groups experienced up to 21% reduction in feed consumption, 11% mortalities, and adverse impacts on hematology, including a decrease in erythrocytes, and monocytes and an increase in leukocytes, thrombocytes, lymphocytes, and neutrophils. Haematological indices like mean corpuscular volume and mean corpuscular hemoglobin decreased, while mean corpuscular hemoglobin concentration increased. The plasma biochemical parameters including glucose and liver and kidney enzymes unveiled a significant dose- and time-dependent increase, while calcium and chloride levels decreased. Erythrocytes displayed several erythrocyte cellular and nuclear abnormalities. The frequency of micronucleus increased with dose and time, suggesting potential genotoxicity of ENF. Additionally, a dose-dependent increase in residues in the tissues with the highest accumulation in muscle was documented. Nevertheless, the recovery of the measured parameters upon dose termination indicated that the ENF-induced alterations are reversible. The study affirmed the safety of ENF at the recommended dose (10 mg) in O. niloticus and their adoptive responses to higher doses.

Investigation of the toxicity and safety concerns of transgenic maize seeds expressing immunogenic F and HN protein genes against Newcastle disease virus.

Introduction: The presented study investigated the potential toxicity and safety concerns associated with transgenic maize seeds expressing immunogenic F and HN protein genes against Newcastle disease virus (NDV). Methodology: The experiment involved feeding Sprague-Dawley rats with transgenic maize seeds formulated into standard diets at levels of 30% (w/w) for a duration of 90 days. The rats were divided into three groups, with 10 rats per group. We assessed various parameters including overall appearance, feed consumption, body weight, organ weight, hematological parameters, serum chemistry, and histopathology. Results: The results of these assessments were compared between the control group and the treatment groups. The study findings revealed that there were no significant differences between the control and treatment groups in terms of overall appearance, feed consumption, body weight, organ weight, hematological parameters, serum chemistry, microscopic histopathology, and gross appearance of tissues. These observations suggest that the consumption of transgenic maize seeds did not lead to any treatment-related adverse effects or toxicological issues. Furthermore, the transgenic maize seeds were found to be nutritionally equivalent to their non-transgenic counterpart. Conclusion: Overall, no physiological, pathological, or molecular toxicity was observed in the Rats fed with transgenic feed.However, it is important to note that this study focused specifically on the parameters measured and the outcomes observed in Sprague-Dawley rats, and further research and studies are necessary to fully evaluate the safety and potential applications of transgenic edible vaccines in humans or other animals.

[Biosafety risks, control, and biocontainment of engineered microalgae].

Microalgae, with the ability to harness solar energy to fix CO2 and convert it into organic compounds, have emerged as promising green cell factories. With the rapid development of cutting-edge biotechnologies, the research and application of photosynthetic microalgae have been expanding, leading to comprehensive and in-depth engineering of microalgae. The synthetic biology and genome editing technologies have enabled the applications of microalgae in medicine, agriculture, food, energy, and the environment. However, the survival and spreading of engineered microalgae in the natural environment pose potential safety risks to ecosystems and human health. To curb the risks caused by the spreading of engineered microalgae in the environment, biosafety policies should be formulated for engineered microalgae and the prevention and control technologies should be developed. Toward this goal, researchers have developed biocontainment systems, including positive strategies such as the design of toxic protein-based kill switches and passive strategies such as knocking out essential genes to construct the strains with nutritional deficiencies, thereby spatially containing engineered microalgae. This article summarizes the application of cutting-edge biotechnologies in the engineering of microalgae, the biosafety risks and management regulations associated with the escape of engineered microalgae, and the progress in novel biocontainment technologies established for engineered microalgae. Finally, this article gives insights into the future development direction of microalgae biocontainment.

Use of Zebrafish (Danio rerio) for Biosafety Evaluation of Strontium Nanostructured Hydroxyapatite.

Despite the numerous studies on biocompatibility with nano-biomaterials, the biological effects of strontium-substituted HA nanoparticles (nSrHA) need to be better understood. So, we conducted an embryotoxicity test using zebrafish (Danio rerio) according to the OECD 236 guideline, a model that represents a viable alternative that bridges the gap between in vitro and mammalian models. Zebrafish embryos were exposed for 120 h to microspheres containing nSrHA nanoparticles with low and high crystallinity, synthesized at temperatures of 5°C (nSrHA5) and 90°C (nSrHA90). We evaluated lethality, developmental parameters, and reactive oxygen species (ROS) production. The larval behavior was assessed at 168 hpf to determine if the biomaterials affected motor responses and anxiety-like behavior. The results showed that the survival rate decreased significantly for the nSrHA5 group (low crystalline particles), and an increase in ROS was also observed in this group. However, none of the biomaterials caused morphological changes indicative of toxicity during larval development. Additionally, the behavioral tests did not reveal any alterations in all experimental groups, indicating the absence of neurotoxic effects from exposure to the tested biomaterials. These findings provide valuable insights into the biosafety of modified HA-based nanostructured biomaterials, making them a promising strategy for bone tissue repair. As the use of hydroxyapatite-based biomaterials continues to grow, it is crucial to ensure rigorous control over the quality, reliability, and traceability of these materials.

Advancements in genetically modified insect pest-resistant crops in India.

MAIN CONCLUSION: The review offers insights into the current state of research on insect pest-resistant GM crops and the regulations governing the cultivation of GM crops in India. India has a rich crop diversity of more than 160 major and minor crops through its diverse agroclimatic conditions. Insect pests alone cause around USD 36 billion in crop loss annually in India. The last two decades witnessed considerable progress in managing insect pests by adopting innovative techniques including transgenics. In research, significant advancement has been brought in insect pest-resistant transgenics in India since its inception in 2002. However, any events have not been endorsed owing to biosafety impediments, except Bt cotton reaching the commercial release stage. A landmark decision to exempt certain types of gene-edited plants from genetically modified organism (GMO) regulations offers great promise for developing novel insect-resistant crops in India. The article reviews the current research on insect pest-resistant transgenics and its regulations in India.

Biomedical applications of chitosan-coated phytogenic silver nanoparticles: An alternative drug to foodborne pathogens.

The biogenic synthesis of silver nanoparticles (AgNPs) was performed using crude rosmarinic acid (RA) from plants as a reducing agent and coated with chitosan biopolymer. The prepared particles were characterized by ultraviolet-visible spectroscopy, Fourier transform infrared spectroscopy, X-ray diffraction (XRD), and transmission electron microscopy (TEM). A surface plasmon resonance peak at 430 nm indicates the emergence of AgNPs. XRD showed that the AgNPs were crystalline with an average crystalline size of 30 nm and TEM studies revelad that AgNPs were spherical without aggregation. The prepared CS-AgNPs exhibited good bactericidal properties against foodborne pathogens, such as Escherichia coli, Pseudomonas aeruginosa, and Vibrio parahaemolyticus. In particular, 100 µg/mL CS-AgNPs inhibited the growth of the selected bacteria and controlled their biofilm-forming ability. Band-aid cloth assay confirmed that the CS-AgNPs could be used in the medical field to prevent bacterial infections. The prepared CS-AgNPs increased the survival rate of Artemia species and exhibited antioxidant activity in conjunction with bactericidal properties against selected foodborne pathogens.

Human and animal intestinal commensals and probiotics vs modern challenges of biosafety: problems and prospects.

The appearance of an array of data on the study of the intestinal microbiota in Metazoa has significantly expanded our understanding of the role of commensals in the control of a wide range of physiological functions in higher organisms in norm and pathology. In the intestine, where the microbial load significantly exceeds the number of microorganisms of other ecosystems, the components of the intestinal microbiota are a constant source of stimuli that induce activation of the host immune system. The introduction into practice of biomedical research of innovative high-resolution methods, including   multi-omics technologies, has brought data that change our understanding of intestinal commensals, including probiotics with GRAS status, widely used in medicine, agriculture and biotechnology. The ability of these bacteria to induce negative processes in the host body that are beneficial for bacterial proliferation and expansion revealed a clear lack of our knowledge about the logic of their life and the mechanisms of interaction with eukaryotic cells. This determines the urgent need for comprehensive research of probiotics and the development of standardization of their safety assessment. Apriori's confidence in the exceptional benefit of the bacteria widely used in medicine, agriculture and biotechnology has determined the seriously omission in our control system today - the lack of standardization of studies for the safety assessment of bacteria with GRAS status . The moment has come when it became clear that this gap should be promptly filled and that only exact understanding the molecular base of interacting the microbes with eukaryotic cells can provide the foundation for effective practical developments in controlling the evolution of bacterial virulence and probiotic safety strategy, as well as the competent use of genetic technologies for monitoring the environment and managing infectious processes, thus avoiding the dramatic consequences of large-scale interventions in the micro and macro worlds.

Implementation of a High-Level Isolation Unit Readiness Checklist in the Irish Setting.

A high-level isolation unit (HLIU) is a specially designed biocontainment unit for suspected or confirmed high-consequence infectious diseases. For most HLIUs, maintaining readiness during times of inactivity is a challenge. In this case study, we describe a checklist approach to assess HLIU readiness to rapidly operate upon activation. This checklist includes readiness criteria in several domains, such as infrastructure, human resources, and material supplies, that are required to safely activate the unit at any time. The checklist audit tool was derived from a novel activation readiness checklist published by the biocontainment unit at The Johns Hopkins Hospital in Baltimore, Maryland. It was then adapted for the Irish healthcare setting and implemented at the Mater Misericordiae University Hospital, Ireland's current isolation facility. Results from the audit were also used to inform recommendations for the construction of a new HLIU to open in 2025. The audit tool is user friendly, practical, and focuses on the essential elements of readiness to ensure a successful rapid operation.

Clinical insights into nanomedicine and biosafety: advanced therapeutic approaches for common urological cancers.

Urological cancers including those of the prostate, bladder, and kidney, are prevalent and often lethal malignancies besides other less common ones like testicular and penile cancers. Current treatments have major limitations like side effects, recurrence, resistance, high costs, and poor quality of life. Nanotechnology offers promising solutions through enhanced diagnostic accuracy, targeted drug delivery, controlled release, and multimodal imaging. This review reflects clinical challenges and nanomedical advances across major urological cancers. In prostate cancer, nanoparticles improve delineation and radiosensitization in radiation therapy, enable fluorescent guidance in surgery, and enhance chemotherapy penetration in metastatic disease. Nanoparticles also overcome bladder permeability barriers to increase the residence time of intravesical therapy and chemotherapy agents. In renal cancer, nanocarriers potentiate tyrosine kinase inhibitors and immunotherapy while gene vectors and zinc oxide nanoparticles demonstrate antiproliferative effects. Across modalities, urological applications of nanomedicine include polymeric, liposomal, and metal nanoparticles for targeted therapy, prodrug delivery, photodynamic therapy, and thermal ablation. Biosafety assessments reveal favorable profiles but clinical translation remains limited, necessitating further trials. In conclusion, nanotechnology holds significant potential for earlier detection, precise intervention, and tailored treatment of urological malignancies, warranting expanded research to transform patient outcomes.

Managing Risk When Working with Orbiviruses with a Special Emphasis on Epizootic Hemorrhagic Disease Virus.

Risk assessment is the cornerstone of working safely with biological agents. The World Health Organization (WHO) Laboratory Biosafety Manual Fourth Edition Monograph on Risk Assessment provides stepwise guidance for completing a risk assessment, from information gathering and identifying hazards to evaluating the risks, developing, and implementing controls and review.To support the development of a mature safety culture within laboratories, it is important that all staff who handle biological agents understand the fundamentals of risk assessment and receive training in identifying hazards created by their work activities (or tasks) and understand how to mitigate the risks arising from carrying out that work. Any "competent" person may be involved in assessing the risks posed by carrying out an activity. Those closest to the work, who understand the details of the task being undertaken, should be involved in creating the risk assessment. The guidance in this chapter is not just applicable to biosafety professionals, laboratory scientists, or facility managers but can be used by any competent worker familiar with the activity being assessed.This chapter uses the guidance from the WHO to apply the principles of risk assessment to working with Epizootic hemorrhagic disease virus (EHDV), using an example activity-virus isolation from EHDV test samples in cell culture.

The GIBACHT fellowship: a multilateral initiative for strengthening capacity in biosafety and biosecurity towards pandemic preparedness.

The German Biosecurity Programme was launched in 2013 with the aim to support partner countries overcome biological threats including natural outbreaks or the intentional misuse of highly pathogenic agents. As part of this programme, this paper describes the development and implementation of a multilateral biosafety and biosecurity training initiative, called 'Global Partnership Initiated Biosecurity Academia for Controlling Health Threats' (GIBACHT). To achieve its objectives, GIBACHT implemented a blended-learning approach with self-directed, distance-based learning phases and three training-of-trainer workshops. The programme follows Kirkpatrick's model of learning to guarantee sustainable effects of improved knowledge and skills. One hundred nine fellows from 26 countries have been trained in seven cohorts. Many GIBACHT alumni have established additional biosafety/biosecurity trainings in their home countries. The knowledge exchange is strengthened by the implementation of a Moodle-based alumni network. GIBACHT has the potential to contribute to strengthening the capacities of partner countries in Africa, the Middle East, and South and Central Asia to respond and build resilience to biological threats.

Evaluation of cleaning methods for change-over after the processing of cell products to avoid cross-contamination risk.

Introduction: Cell-processing facilities face the risk of environmental bacteria contaminating biosafety cabinets during processing, and manual handling of autologous cell products can result in contamination. We propose a risk- and evidence-based cleaning method for cross-contamination, emphasizing proteins and DNA. Methods: The transition and residual risks of the culture medium were assessed by measuring both wet and dried media using fluorescence intensity. Residual proteins and DNA in dried culture medium containing HT-1080 cells were analyzed following ultraviolet (UV) irradiation, wiping, and disinfectant treatment. Results: Wet conditions showed a higher transition to distilled water (DW), whereas dry conditions led to higher residual amounts on SUS304 plates. Various cleaning methods for residual culture medium were examined, including benzalkonium chloride with a corrosion inhibitor (BKC + I) and DW wiping, which demonstrated significantly lower residual protein and DNA compared to other methods. Furthermore, these cleaning methods were tested for residual medium containing cells, with BKC + I and DW wiping resulting in an undetectable number of cells. However, in some instances, proteins and DNA remained. Conclusions: The study compared cleaning methods for proteins and DNA in cell products, revealing their advantages and disadvantages. Peracetic acid (PAA) proved effective for nucleic acids but not proteins, while UV irradiation was ineffective against both proteins and DNA. Wiping emerged as the most effective method, even though traceability remained challenging. However, wiping with ETH was not effective as it caused protein immobilization. Understanding the characteristics of these cleaning methods is crucial for developing effective contamination control strategies.

The state of biosafety across China's CDC microbiology laboratories: insights from a nationwide survey (2021-2023).

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.

Xenobiology for the Biocontainment of Synthetic Organisms: Opportunities and Challenges.

Since the development of recombinant DNA technologies, the need to establish biosafety and biosecurity measures to control genetically modified organisms has been clear. Auxotrophies, or conditional suicide switches, have been used as firewalls to avoid horizontal or vertical gene transfer, but their efficacy has important limitations. The use of xenobiological systems has been proposed as the ultimate biosafety tool to circumvent biosafety problems in genetically modified organisms. Xenobiology is a subfield of Synthetic Biology that aims to construct orthogonal biological systems based on alternative biochemistries. Establishing true orthogonality in cell-based or cell-free systems promises to improve and assure that we can progress in synthetic biology safely. Although a wide array of strategies for orthogonal genetic systems have been tested, the construction of a host harboring fully orthogonal genetic system, with all parts operating in an orchestrated, integrated, and controlled manner, still poses an extraordinary challenge for researchers. In this study, we have performed a thorough review of the current literature to present the main advances in the use of xenobiology as a strategy for biocontainment, expanding on the opportunities and challenges of this field of research.

[Investigation of the Biosafety of Commercially Available Natural Rubber Latex and Synthetic Polyurethane Condom Materials]. / å¸‚å”®å¤©ç„¶æ©¡èƒ¶èƒ¶ä¹³å’Œäººå·¥åˆæˆèšæ°¨é ¯æè´¨é¿å­•å¥—çš„ç”Ÿç‰©å®‰å ¨æ€§ç ”ç©¶.

Objective: To investigate the biological safety of commercially available natural rubber latex and synthetic polyurethane condoms. Methods: Natural rubber latex condom brands of A1 and A2 and polyurethane condom brands of B1 and B2 were purchased from large chain pharmacies in Chengdu, with three packages randomly selected for each brand. The study assessed the toxic effects of condom extracts on L-929 mouse fibroblasts according to GB/T standards. Gross observation and histopathological evaluation were conducted to assess the irritation reactions of condoms on the vagina and penis of rabbits (3 rabbits were used for each brand), as well as their sensitization effects on guinea pig skin. Additionally, the impact of continuous perfusion of condom extracts of the vaginas of SD rats for 30 days on their reproductive systems was evaluated, following GB/T standards (5 rats were used for each brand). Results: Extracts from natural rubber latex condom brands A1 and A2, at concentrations of 100% and 50%, exhibited significant cytotoxicity, with optical density (OD) values being significantly lower than those of the blank control group and the polyurethane condom brands B1 and B2 (P<0.01). There was no significant difference in cell morphology and OD values between the extracts of B1 and B2 and the blank control group (P>0.05). Vaginal congestion was found in 3 rabbits from A1 group and 1 rabbit from the A2 group, while no obvious congestion was noted in rabbits from the B1 and the B2 groups. Histopathological examination showed scattered inflammatory cell infiltration in the vaginal tissue of 3 rabbits from the A1 group and 2 rabbits from the A2 group, and slight congestion in the blood vessels of the lamina propria. No obvious pathological changes were observed in the vaginal tissue of polyurethane brand rabbits. Two rabbits from the A1 group and 1 rabbit from the A2 group showed transient and mild erythema on the penis during the experiment. Histopathological examination showed that 1 rabbit from A1 group had small foci of pericapillary lymphocytes in the dermis of the penis, while no significant pathological changes were observed in the penile tissue of A2, B1, and B2 groups. After 30 days of continuous vaginal perfusion with condom extract, 3 rats in A1 group and 2 rats in the A2 group had uterine congestion, with the degree of congestion being lower in the A2 group. No significant congestion or pathological changes were observed in the vaginal and penile tissues of rabbits, or in the uterine tissues of rats from the polyurethane groups. None of the 4 groups of guinea pigs showed significant skin allergic reactions to the condom extracts. Conclusion: Significant differences in biosafety exist among condoms of various materials and brands. To ensure product safety, it is crucial to strengthen quality control and regulatory oversight after condoms become commercially available.