The pervasive nature of infections causing major outbreaks have elevated biosafety and biosecurity as a fundamental component for resilient national laboratory systems. In response to international health security demands, the Global Health Security Agenda emphasizes biosafety as one of the prerequisites to respond effectively to infectious disease threats. However, biosafety management systems (BMS) in low-medium income countries (LMIC) remain weak due to fragmented implementation strategies. In addition, inefficiencies in implementation have been due to limited resources, inadequate technical expertise, high equipment costs, and insufficient political will. Here we propose an approach to developing a strong, self-sustaining BMS based on extensive experience in LMICs. A conceptual framework incorporating 15 key components to guide implementers, national laboratory leaders, global health security experts in building a BMS is presented. This conceptual framework provides a holistic and logical approach to the development of a BMS with all critical elements. It includes a flexible planning matrix with timelines easily adaptable to different country contexts as examples, as well as resources that are critical for developing sustainable technical expertise.
The phospholipid and ganglioside composition in bone marrow progenitors of lymphocytes, thymocytes and mature lymphocytes of intact rats and rats with sarcoma 45 were studied. The lymphocytes and their progenitors were isolated by Ficoll-Paque density centrifugation. The phospholipids and gangliosides were separated by thin-layer chromatography following standard chloroform:methanol extraction from the cells. Alterations in the lipid spectrum (both phospholipids and gangliosides) were shown to take place during lymphocyte differentiation. The rate of ganglioside sialylation diminished, which was expressed as an increase in mono- and di-, and a decrease in tri- and tetrasialoganglioside levels. Tumor-induced alterations in lymphocyte lipid composition involve all stages of lymphocyte differentiation. These shifts are believed to be connected with a disturbance of the antineoplastic function of lymphocytes and, consequently, the immune response of the tumor-bearing organism.
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.
Introduction Early warning and objective evidence of systematic errors in laboratory diagnosis ensures evidence based corrective and preventive actions that instill patient safety and confidence. External quality assessment contributes significantly to the above as an essential component of laboratory quality assurance. However, implementation of External Quality Assessment in resource-limited settings is challenged by high costs of enrolling in international schemes. To ensure sustainability, a National External Quality Assessment Program in Armenia was developed using a One Health approach. Methods Through engagement of stakeholders from Ministry of Health and Department of Agriculture under Ministry of Economy the government of Armenia started the implementation of the Armenia Laboratory External Quality Assessment (ALEQA) program. Policies and procedures were defined, a web interface for return of results and feedback reporting was created. A training was offered for characterization of simulated samples for bacterial pathogens. Following a pilot survey, the program was successfully scaled up, with later addition of a Brucella serology discipline. Results The return rate of results was 100% for all surveys. There was an improvement in the performance of the laboratories from the 2015 to the 2019 surveys. The bacterial pathogens EQA survey's, was interrupted between 2017 and 2019. The Brucella Serology survey showed 77% of the 26 participating laboratories had satisfactory performance. Conclusion This is one of the few National EQA Programs that have embraced the One Health approach to improve reach of EQA Programs in resource-limited settings in both human and veterinary laboratories.
Brucellosis remains one of the major zoonotic diseases worldwide and requires a One Health approach for early detection and control. One of the crucial components for brucellosis control and spread is timely and reliable laboratory diagnosis. External quality assessment is a key component of laboratory quality assurance to evaluate performance and identify possible insufficiencies in laboratory practices. Implementation of brucellosis external quality assessment in resource-limited countries are rare and challenging due to logistical and financial difficulties. The aim of this study was to evaluate the stability of dried tube specimens for external quality assessment of brucellosis serological testing that could be used in resource-limited countries to avoid logistical and financial constraints associated with use of sera. Prepared dried tube specimen panels consisted of 5 samples, one negative and 4 positive samples ranging from weak positive to strong positive. It was shown that brucellosis dried tube specimens were stable at room temperature for 105 days (15 weeks). Consistent results were observed for all samples by rose bengal test during weekly stability testing and also at the end of the stability period by complement fixation test, enzymelinked immunosorbent assays, and fluorescence polarization assay. In conclusion, brucellosis dried tube specimen maintains integrity of serum samples for serological testing of brucella infection and can be a powerful tool for external quality assessment providers, as it decreases huge shipping costs and avoids challenges in maintaining cold chain shipments between the provider and the recipient laboratories. Moreover, it has great prospects for enabling expansion of external quality assessment programs to include lower tier labs in resource-limited countries to monitor and improve the quality and accuracy of brucellosis testing, as well as it could be used for transportation of clinical samples from remote areas without cold chain logistics.Dried tube specimen preparation and stability validation for brucellosis serological external quality assessment and quality control materials in resource-limited settings Short running title: Brucellosis dried tube specimen validation
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