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In view of the approaching application date of Regulation (EU) 2017/746 („IVDR“) and the resulting EU-wide, harmonized requirements for in-vitro diagnostic medical devices (IVD) manufactured and used within European health institutions, the Ad hoc Commission IVD of the German Association of the Scientific Medical Societies (AWMF) takes a national position on the details of the requirements and conditions related to the use of these IVD products.The Ad hoc Commission IVD emphasizes the relevance of examination procedures developed in medical laboratories, especially in the field of orphan diseases and new diagnostic markers. The IVDR sets an adequate regulatory framework for IVD manufactured and used within health institutions as long as these requirements are fulfilled with reliability and in accordance with the current state of the art in medical laboratory sciences. At the same time, the IVDR requirements have to be regarded under a pragmatic view and in accordance with the quality management systems approved within the different EU Member States. On the one hand, the mandatory requirements of the RiLiBÄK play an essential role in Germany. On the other hand, elements of voluntarily applicable international standards may support the fulfilment of product requirements for safety and performance according to Annex I of the IVDR. Both the complexity and possible solutions for the implementation of the IVDR requirements are discussed on the basis of examples such as the required documentation, performance evaluation and software validation.The Ad hoc Commission IVD recommends that, while aiming at a preferably EU-wide harmonized interpretation of the IVDR requirements, the flexibility in medical laboratory diagnostics necessary for patient care, including the use of IVD from in-house production, should be emphasized.

BackgroundEstablishing a methodology for assessing nutritional behavior comprehensively and accurately poses a great challenge. Mobile technologies such as mobile image-based food recording apps enable eating events to be assessed in the moment in real time, thereby reducing memory biases inherent in retrospective food records. However, users might find it challenging to take images of the food they consume at every eating event over an extended period, which might lead to incomplete records of eating events (missing events). ObjectiveAnalyzing data from 3 studies that used mobile image-based food recording apps and varied in their technical enrichment, this study aims to assess how often eating events (meals and snacks) were missed over a period of 8 days in a naturalistic setting by comparing the number of recorded events with the number of normative expected events, over time, and with recollections of missing events. MethodsParticipants in 3 event-based Ecological Momentary Assessment (EMA) studies using mobile image-based dietary assessments were asked to record all eating events (study 1, N=38, 1070 eating events; study 2, N=35, 934 eating events; study 3, N=110, 3469 eating events). Study 1 used a basic app; study 2 included 1 fixed reminder and the possibility to add meals after the actual eating events occurred instead of in the moment (addendum); and study 3 included 2 fixed reminders, an addendum feature, and the option to record skipped meals. The number of recalled missed events and their reasons were assessed by semistructured interviews after the EMA period (studies 1 and 2) and daily questionnaires (study 3). ResultsOverall, 183 participants reported 5473 eating events. Although the momentary adherence rate as indexed by a comparison with normative expected events was generally high across all 3 studies, a differential pattern of results emerged with a higher rate of logged meals in the more technically intensive study 3. Multilevel models for the logging trajectories of reported meals in all 3 studies showed a significant, albeit small, decline over time (b=−.11 to −.14, Ps

Nowadays, fiber composites are among the most important construction materials in lightweight design. Increasingly, attempts are being made to replace fossil raw materials with bio-based materials in order to improve their recyclability and reduce greenhouse gas emissions. While processes suitable for industrial use already exist for the production of biopolymers as matrix materials, there is still a considerable need for research in the production of bio-based reinforcing fibers. For hemp bast strips (HBS), promising utilization options arise due to very good mechanical properties. However, current processes for extracting such raw materials from bast fiber plants result in damage to the fiber structure because they use biochemical decomposition processes and/or squeeze and crush large disordered amounts of stalk along their entire length. This strongly reduces the application potential of the raw materials. A newly developed principle extracts the HBS with minimal impact by dividing single hemp stalks only at one end and then isolating them from the wood core by pulling on the resulting wood fragments. In this manner, the fiber structure and the good mechanical properties are largely retained and the HBS obtained can be stored in parallel alignment for further processing with little effort. [ABSTRACT FROM AUTHOR]

Introduction: Lonoctocog alfa is a single‐chain factor VIII (FVIII) molecule with high binding affinity to von‐Willebrand‐factor. While it is well known that its plasma activity is underestimated by one‐stage clotting assays (OSCA), there is a lack of knowledge on the post‐infusion performance of lonoctocog alfa in global coagulation assays or its potential impact on the haemostatic balance in vivo. Aim: To characterize lonoctocog alfa versus octocog alfa in pre‐ and post‐infusion samples obtained from patients undergoing repeated investigation of incremental recovery (IR). Methods: Eighteen patients with severe haemophilia A (lonoctocog alfa: 10, octocog alfa: 8) were included. A panel of factor‐specific and global coagulation assays was applied, comprising a FVIII OSCA, two FVIII chromogenic substrate assays (CSA), rotational thrombelastography and thrombin generation (TG). Potential activation of coagulation was assessed by measuring plasma thrombin markers and levels of activated protein C. Results: Comparable IRs were found for lonoctocog alfa and octocog alfa (2.36 [IU/dL]/[IU/kg] vs. 2.55 [IU/dL]/[IU/kg], respectively). Lonoctocog alfa activities were found to be underestimated by the FVIII OSCA while also the two FVIII CSAs showed statistically significant assay discrepancies on lonoctocog alfa. Effects of both FVIII products on rotational thrombelastography were less distinct than those on TG parameters. No elevated pre‐ or significantly shifting post‐infusion plasma levels of coagulation biomarkers were detected. Conclusion: Lonoctocog alfa and octocog alfa showed comparable recovery and safety in vivo as well as similar impacts on TG in vitro. Observed assay discrepancies on lonoctocog alfa demonstrated variability of results also between different FVIII CSAs. [ABSTRACT FROM AUTHOR]

Sepsis-associated coagulopathy increases risk of mortality. Impairment of the anticoagulant protein C (PC) pathway may contribute to the thrombotic phenotype in coronavirus disease 2019 (COVID-19) sepsis. This study assessed the functionality of this pathway in COVID-19 and non-COVID sepsis by measuring its key enzymes, thrombin and activated PC (APC). The study population included 30 patients with COVID-19, 47 patients with non-COVID sepsis, and 40 healthy controls. In healthy controls, coagulation activation and subsequent APC formation was induced by 15 µg/kg recombinant activated factor VII one hour before blood sampling. APC and thrombin in plasma were measured using oligonucleotide-based enzyme capture assays. The indirect thrombin markers prothrombin-fragment 1+2 (F1+2) and thrombin-antithrombin complex (TAT) were also measured. Compared with stimulated healthy controls, median thrombin, F1+2, and TAT levels were higher in patients with COVID-19 (up to 6-fold, p < 2 × 10−6) and non-COVID sepsis (up to 4.7-fold, p < 0.010). APC levels were 2.4-fold higher in patients with COVID-19 (7.44 pmol/L, p = 0.011) and 3.4-fold higher in non-COVID sepsis patients (10.45 pmol/L, p = 2 × 10−4) than in controls (3.08 pmol/L). Thrombin markers and APC showed correlation in both COVID-19 (r = 0.364–0.661) and non-COVID sepsis patients (r = 0.535–0.711). After adjustment for PC levels, median APC/thrombin, APC/F1+2, and APC/TAT ratios were 2-fold (p = 0.036), 6-fold (p = 3 × 10−7) and 3-fold (p = 8 × 10−4) lower in the COVID-19 group than in the non-COVID sepsis group, and the latter two were also lower in the COVID-19 group than in stimulated healthy controls. In conclusion, it was found that a comparatively lower anticoagulant APC response in COVID-19 patients as compared to non-COVID sepsis patients, potentially linked to endothelial dysfunction, contributes to the prothrombotic phenotype of COVID-19 sepsis. [ABSTRACT FROM AUTHOR]

This paper focuses on the module "Fundamentals of Electrical Engineering," in which students from different engineering disciplines often face difficulties. Despite efforts to enhance the course through digital media, the formation of study groups, and adjusted lecture and exercise materials, there is still a high failure rate in the subject, leading to potential student dropouts. The primary goal is to analyze students' challenges in solving electrical engineering problems to evaluate their grasp of the fundamentals of electrical engineering and identify varying levels of competence. The findings are based on a cross-sectional study conducted at the conclusion of a university course in Germany, involving 196 students. Through item response theory (IRT) analyses, it was determined that the assessment items demonstrated satisfactory fit values. The proficiency model delineates four levels, with only 8.2% of students achieving the highest level. At this stage, students can tackle more intricate problems using circuit analysis techniques. However, a notable portion of students (40.3%) lack a basic understanding of electrical circuits, placing them at the lowest level. [ABSTRACT FROM AUTHOR]

This study characterized ocean biological carbon pump metrics in the second iteration of the REgional Carbon Cycle Assessment and Processes (RECCAP2) project. The analysis here focused on comparisons of global and biome‐scale regional patterns in particulate organic carbon (POC) production and sinking flux from the RECCAP2 ocean biogeochemical model ensemble against observational products derived from satellite remote sensing, sediment traps, and geochemical methods. There was generally good model‐data agreement in mean large‐scale spatial patterns, but with substantial spread across the model ensemble and observational products. The global‐integrated, model ensemble‐mean export production, taken as the sinking POC flux at 100 m (6.08 ± 1.17 Pg C yr−1), and export ratio defined as sinking flux divided by net primary production (0.154 ± 0.026) both fell at the lower end of observational estimates. Comparison with observational constraints also suggested that the model ensemble may have underestimated regional biological CO2 drawdown and air‐sea CO2 flux in high productivity regions. Reasonable model‐data agreement was found for global‐integrated, ensemble‐mean sinking POC flux into the deep ocean at 1,000 m (0.65 ± 0.24 Pg C yr−1) and the transfer efficiency defined as flux at 1,000 m divided by flux at 100 m (0.122 ± 0.041), with both variables exhibiting considerable regional variability. The RECCAP2 analysis presents standard ocean biological carbon pump metrics for assessing biogeochemical model skill, metrics that are crucial for further modeling efforts to resolve remaining uncertainties involving system‐level interactions between ocean physics and biogeochemistry. Plain Language Summary: Phytoplankton in the surface ocean create each year an amount of organic carbon approximately equivalent to all the annual photosynthesis by plants on land. A small fraction of this newly formed organic carbon is exported below the surface layer, and an even smaller amount makes it all the way to the deep ocean. The transport of organic carbon to the sub‐surface ocean, called the biological carbon pump, influences the global‐scale distributions of ocean nutrients, oxygen, and inorganic carbon as well as the amount of carbon dioxide in the atmosphere. The global rates and geographic patterns of photosynthesis and carbon flux out of the surface ocean have previously been constructed from ship measurements and satellite remote sensing. Here, we compare these observation‐based estimates to a suite of three‐dimensional numerical ocean models and find broadly similar results. The model simulations also capture aspects of the biological carbon pump deeper in the water column, where there are fewer direct constraints from field observations. Our comparison of observations and simulations identifies some deficiencies in the models that should be corrected in order to better simulate climate change impacts on the biological carbon pump. Key Points: Global‐scale, ocean biogeochemical simulations are compared with observation‐based estimates of the marine biological carbon pumpA multi‐model ensemble exhibits good agreement with observation‐based metrics for carbon export flux and transfer efficiencyBased on identified model‐observation and inter‐model differences, we provide guidance for future model evaluations and development [ABSTRACT FROM AUTHOR]