| 1. |
- Aerts, Olivier, et al.
(författare)
-
Isobornyl Acrylate
- 2020
-
Ingår i: Dermatitis. - 1710-3568. ; 31:1, s. 4-12
-
Tidskriftsartikel (refereegranskat)abstract
- Multidisciplinary collaboration between several European dermatology departments has identified isobornyl acrylate (IBOA; CAS 5888-33-5), once deemed a low-risk sensitizer, as a major culprit contact allergen in glucose sensors and insulin pumps, medical devices used by diabetes patients worldwide. Although the patch test modalities of IBOA have been fairly well characterized, intriguing questions remain. For example, its cross-reactive profile to other acrylates remains to be determined, and the striking occurrence of concomitant positive patch test reactions to sesquiterpene lactones needs to be further elucidated. Importantly, the path to its discovery as a contact sensitizer in diabetes devices and the difficulties that were associated with this quest illustrate that apparent difficulties in obtaining sufficient cooperation from the medical device industry may seriously hamper the correct workup of cases of allergic contact dermatitis. The IBOA saga will convince companies to lend more cooperation to dermatologists and policymakers to side with patients and physicians when it comes to updating medical device regulations, including the compulsory labeling of medical devices in general and of diabetes devices in particular.
|
|
| 2. |
- Bachmann, Till T., et al.
(författare)
-
Expert guidance on target product profile development for AMR diagnostic tests
- 2023
-
Ingår i: BMJ Global Health. - : BMJ Publishing Group. - 2059-7908. ; 8:12
-
Tidskriftsartikel (refereegranskat)abstract
- Diagnostics are widely considered crucial in the fight against antimicrobial resistance (AMR), which is expected to kill 10 million people annually by 2030. Nevertheless, there remains a substantial gap between the need for AMR diagnostics versus their development and implementation. To help address this problem, target product profiles (TPP) have been developed to focus developers’ attention on the key aspects of AMR diagnostic tests. However, during discussion between a multisectoral working group of 51 international experts from industry, academia and healthcare, it was noted that specific AMR-related TPPs could be extended by incorporating the interdependencies between the key characteristics associated with the development of such TPPs. Subsequently, the working group identified 46 characteristics associated with six main categories (ie, Intended Use, Diagnostic Question, Test Description, Assay Protocol, Performance and Commercial). The interdependencies of these characteristics were then identified and mapped against each other to generate new insights for use by stakeholders. Specifically, it may not be possible for diagnostics developers to achieve all of the recommendations in every category of a TPP and this publication indicates how prioritising specific TPP characteristics during diagnostics development may influence (or not) a range of other TPP characteristics associated with the diagnostic. The use of such guidance, in conjunction with specific TPPs, could lead to more efficient AMR diagnostics development.
|
|
| 3. |
- Iseri, Emre, et al.
(författare)
-
Digital dipstick: miniaturized bacteria detection and digital quantification for the point-of-care
- 2020
-
Ingår i: Lab on a Chip. - : Royal Society of Chemistry (RSC). - 1473-0197 .- 1473-0189. ; 20:23, s. 4349-4356
-
Tidskriftsartikel (refereegranskat)abstract
- Established digital bioassay formats, digital PCR and digital ELISA, show extreme limits of detection, absolute quantification and high multiplexing capabilities. However, they often require complex instrumentation, and extensive off-chip sample preparation. In this study, we present a dipstick-format digital biosensor (digital dipstick) that detects bacteria directly from the sample liquid with a minimal number of steps: dip, culture, and count. We demonstrate the quantitative detection of Escherichia coli (E. coli) in urine in the clinically relevant range of 102 –105 CFU ml−1 for urinary tract infections. Our format shows 89% sensitivity to detect E. coli in clinical urine samples (n = 28) when it is compared to plate culturing (gold standard). The significance and uniqueness of this diagnostic test format is that it allows a non-trained operator to detect urinary tract infections in the clinically relevant range in the home setting.
|
|
| 4. |
- Morel, Chantal M., et al.
(författare)
-
A one health framework to estimate the cost of antimicrobial resistance
- 2020
-
Ingår i: Antimicrobial Resistance and Infection Control. - : Springer Science and Business Media LLC. - 2047-2994. ; 9:1
-
Tidskriftsartikel (refereegranskat)abstract
- Objectives/purpose: The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ONeuro) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized analyses for quantifying the full economic burden attributable to AMR at the global level.Methods: GAP-ONeuro (funded under the JPIAMR 8th call (Virtual Research Institute) is composed of 19 international networks and institutions active in the field of AMR. For this project, the Network operated by means of Delphi rounds, teleconferences and face-to-face meetings. The resulting costing framework takes a bottom-up approach to incorporate all relevant costs imposed by an AMR bacterial microbe in a patient, in an animal, or in the environment up through to the societal level.Results: The framework itemizes the epidemiological data as well as the direct and indirect cost components needed to build a realistic cost picture for AMR. While the framework lists a large number of relevant pathogens for which this framework could be used to explore the costs, the framework is sufficiently generic to facilitate the costing of other resistant pathogens, including those of other aetiologies.Conclusion: In order to conduct cost-effectiveness analyses to choose amongst different AMR-related interventions at local level, the costing of AMR should be done according to local epidemiological priorities and local health service norms. Yet the use of a common framework across settings allows for the results of such studies to contribute to cumulative estimates that can serve as the basis of broader policy decisions at the international level such as how to steer R&D funding and how to prioritize AMR amongst other issues. Indeed, it is only by building a realistic cost picture that we can make informed decisions on how best to tackle major health threats.
|
|
| 5. |
- van der Wijngaart, Wouter, et al.
(författare)
-
Electrostatic sampling of patient breath for pathogen detection : a pilot study
- 2020
-
Ingår i: Frontiers in Mechanical Engineering. - : Frontiers Media SA. - 2297-3079. ; 6
-
Tidskriftsartikel (refereegranskat)abstract
- Collecting samples for diagnosis of respiratory infections can be invasive and highly uncomfortable for patients; with sampling techniques ranging from nasal or throat swabs to bronchoalveolar lavage. In this work, we explore the electrostatic capture of exhaled pathogens as a non-invasive sampling method for rapid diagnosis in a primary care setting. A pilot study at primary care centers in Belgium enrolled 20 patients presenting with flu-like symptoms whose diagnosis was determined by nasopharyngeal (NP) swabs. We collected exhaled aerosol particles from infected patients using a breath electrostatic sampler (BESS) and using filters, following an extremely light procedure consisting of five normal exhales. All samples were analyzed using a commercial multiplex q-RT-PCR panel assay. Staphylococcus aureus (S. aureus) was detected from BESS samples of 7 patients; 3 of whom were in agreement with their corresponding diagnoses. The BESS method was negative for exhaled viruses. We detected viruses, but no bacteria, with the filters, but the results showed no correlation with the corresponding diagnosis. Our results indicate that electrostatic sampling of exhaled breath is a technique and approach potentially suited for the primary care setting, where it might constitute a helpful diagnostic device.
|
|
