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    Method Development and Validation of an Aerosol Sampling Technique for the Analysis of Nicotine in Electronic Cigarette Aerosols

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    Because of the increasing popularity of e-cigarettes, monitoring the e-cigarette market has become important for national health authorities to guarantee safety and quality. In the EU, the Tobacco Products Directive requires emission studies for e-cigarette products. The absence of industry guidelines for studying these emissions and the lack of proper validation in the literature led us to develop and validate a method using the total error approach for the determination of nicotine in e-cigarette aerosols. A commercial vaping device was used to generate aerosols, which were then collected on Cambridge filter pads and measured for nicotine concentration by UHPLC-DAD after extraction. The method was successfully validated by generating accuracy profiles, which show that the β-expectation tolerance intervals remained below the acceptance limits of ±20%. Within-run repeatability and intermediate precision were considered acceptable since the highest RSD value obtained was below 5%. The method was applied to 15 commercial e-liquids. A complete validation of a method for the analysis of e-cigarette emissions is presented, including several parameters that impact the accuracy and reproducibility. Similar systematic approaches for method development and validation could be&nbsp;u</p

    Trauma Exposure, Social Support and Mental Health in the General Population in Belgium

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    Introduction: International research has shown that trauma exposure can lead to mental health disorders and affect social support. However, there is little insight into trauma exposure and its related issues in the general population of Belgium. Methods: Secondary cross-sectional data on the general adult population were retrieved from the Belgian Health Interview Survey. Using a representative sample, data were collected on trauma exposure in the past 12 months, and the disclosure of trauma, social support, depressive/anxiety symptoms and background factors were investigated. Results: In total, 7728 participants were included in this study, and 4.8% (N = 369) reported trauma exposure within the past 12 months. People with trauma exposure (4.8%, N = 369) consistently had more anxiety and depressive symptoms than those without trauma (p&nbsp;&lt; 0.001), and people with multiple trauma exposures had more symptoms than those with a single trauma (p&nbsp;&lt; 0.001). Social support was observed to be lower among those with trauma exposure (p&nbsp;&lt; 0.001), and 17.1% had never disclosed their trauma to anyone. Sexual violence was higher among women (64.5%) and was also the least disclosed form of trauma. Conclusions: Trauma exposure is associated with poorer mental health in Belgium. Around a fifth of those who experience trauma do not disclose their trauma, which is the most common after sexual&nbsp;violence</p

    QC as a basis for human application of phage therapy in Belgium

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    Bacteriophages (phages) are viruses that specifically target and eliminate bacteria. They have been used as antimicrobial agents for over a century, notably in the former Soviet Union. Unfortunately, the differences between Soviet medical practice and reporting of clinical data and the current regulatory standards upheld by Western countries make it impossible to draw any conclusions about the safety and efficacy of phage therapy, without additional high-quality studies. However, due to the global increase in antimicrobial resistance, the potential of phages as a viable alternative treatment strategy has gained more interest in the last two decades, encouraging research in the field.&nbsp;&nbsp; &nbsp; In Belgium, more than a hundred patients have already benefited from phage therapy. Although the initial treatments were administered under the provisions of Article 37 of the Declaration of Helsinki (Unproven Interventions in Clinical Practice), the majority of patients received phage treatment thanks to a novel, dedicated regulatory framework established in 2018, known as “The Magistral Phage”. This pragmatic personalized therapy approach allows the use of phage products as active pharmaceutical ingredients (API) in a magistral preparation, specifically designed for an individual patient. The process necessitates the certification of the product, which includes a genomic passport of the phage and a quality control of the product batch, by a laboratory recognized by the national health&nbsp;authority. &nbsp; Our presentation will delve into five years of experience with the quality control (QC) of therapeutic phage products intended as API. We will illustrate the current flow chart of the certification process employed in Belgium, based on the findings from more than 60 batches of phage productions. The choice of approaches and methodologies for genetic analyses and pyrogenicity assessment will be discussed, and potential future developments, supported by data generated through ongoing research projects, will be addressed. Advances in technology and methodology, guided by regulations such as the upcoming general chapter 5.31 in the European Pharmacopoeia, will play a key role in refining QC processes. Ultimately, this will enhance the reliability of phage therapy products, paving the way for their wider acceptance in the medical&nbsp;community.</p

    Nationwide quality assurance of high-throughput diagnostic molecular testing during the SARS-CoV-2 pandemic: role of the Belgian National Reference Centre

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    Since the onset of the coronavirus disease (COVID-19) pandemic in Belgium, UZ/KU Leuven has played a crucial role as the National Reference Centre (NRC) for respiratory pathogens, to be the first Belgian laboratory to develop and implement laboratory developed diagnostic assays for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) and later to assess the quality of commercial kits. To meet the growing demand for decentralised testing, both clinical laboratories and government-supported high-throughput platforms were gradually deployed across Belgium. Consequently, the role of the NRC transitioned from a specialised testing laboratory to strengthening capacity and coordinating quality assurance. Here, we outline the measures taken by the NRC, the national public health institute Sciensano and the executing clinical laboratories to ensure effective quality management of molecular testing throughout the initial two years of the pandemic (March 2020 to March&nbsp;2022).</p

    Monovalent XBB.1.5 COVID-19 vaccine effectiveness against hospitalisations and deaths during the Omicron BA.2.86/JN.1 period among older adults in seven European countries: A VEBIS-EHR network study.

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    BACKGROUND: We aimed to estimate XBB.1.5 vaccine effectiveness (VE) against COVID-19-related hospitalizations and deaths during BA.2.86/JN.1 predominance, among EU/EEA individuals&nbsp;with ≥65-years. RESEARCH DESIGN AND METHODS: We linked electronic health records to create historical cohorts in Belgium, Denmark, Italy, Navarre (Spain), Norway, Portugal and Sweden. We included individuals aged ≥65-years eligible for the autumnal 2023 COVID-19 vaccine. Follow-up started when ≥80% of country-specific sequenced viruses were BA.2.86/JN.1 (4/dec/23 to 08/jan/24) and ended 25 February 2024. At study site level, we estimated the vaccine confounder-adjusted hazard ratio (aHR) of COVID-19&nbsp;hospitalizations and deaths between individuals with ≥14 days after vaccination versus unvaccinated in autumn 2023, overall, by time since vaccination and age groups. VE was estimated as (1-pooled aHR)x100 with a random-effects&nbsp;model. RESULTS: XBB.1.5 VE against COVID-19&nbsp;hospitalizations was 50% (95%CI: 45 to 55) and 41% (95%CI: 35 to 46) in 65-79-year-olds and in ≥80-year-olds, respectively. VE against COVID19-related-death was 58% (95%CI: 42 to 69) and 48% (95%CI: 38 to 57), respectively, in both age groups. VE estimates against each outcome declined in all age groups over&nbsp;time. CONCLUSION: Monovalent XBB.1.5 vaccine had a moderate protective effect against severe and fatal COVID-19 likely caused by BA.2.86/JN.1 during the 2023/2024 winter, among persons&nbsp;aged ≥65.</p

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