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BACKGROUND: The Sysmex XN-V is derived from the new Sysmex XN series of human hematology analyzers. The main changes from the previously validated XT-2000iV analyzer include an optic-fluorescent analysis for platelets and a nucleated red blood cell (NRBC) count. OBJECTIVE: We aimed to validate the Sysmex XN-V for feline blood following the American College for Veterinary Clinical Pathology and International Council for Standardization in Hematology recommendations. METHODS: Feline EDTA blood specimens were analyzed on the Sysmex XN-V to evaluate repeatability, linearity, comparison with the XT-2000iV analyzer and manual methods, stability, and to verify the previously established Sysmex XT-2000iV RIs. RESULTS: Repeatability was excellent for most variables. Visually determined linearity was excellent or good for most variables except eosinophils and platelet variables. The correlation between the XN-V and XT-2000iV analyzers was good (≥0.82) for all variables except reticulocyte indices. Correlations between the Sysmex XN-V and manual differential counts were good to excellent for most variables, acceptable for neutrophils, and fair for monocytes and NRBC. The previously established Sysmex XT-2000iV RIs can be used to interpret results from the Sysmex XN-V analyzer for most variables except red cell distribution width and reticulocyte variables. The RI for platelet variables could not be evaluated because of platelet clumps. Changes in the Sysmex XN-V measurements after storage at 4 and 24°C were similar to those described for the Sysmex XT-2000iV analyzer. CONCLUSIONS: The performance of the Sysmex XN-V analyzer was good and compared favorably with the Sysmex XT-2000iV analyzer.

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Background: Osteoporosis vertebral compression fractures (OVCF) are common with the aging process. This study aimed to compare the effects of unilateral transverse process extrapedicular (UEPKP) and bilateral transpedicular percutaneous kyphoplasty (BTPKP) for patients with thoracolumbar OVCF. Methods: Data from 136 patients with OVCF treated with single-level PKP in our hospital between May 2019 and April 2021 were studied. Patients were grouped based on surgical procedure: there were 62 patients in the UEPKP group and 74 in the BTPKP group. All clinical and radiological data were collected from medical records. Clinical outcomes, including visual analog scale (VAS), Oswestry Disability Index (ODI), and Japanese Orthopaedic Association (JOA) scores of the lumbar spine, were evaluated preoperatively, postoperatively, and at the follow-up visit. The radiological evaluations (anterior vertebral height rate and local kyphosis angle) and complications were also collected. Results: All patients had successfully improved after surgery. In the UEPKP group, patients showed a significantly shorter operating time and lower fluoroscopy frequency than patients in the BTPKP group (p < 0.05). However, a significantly better distribution score and cement volume were found in the BTPKP group (p < 0.05). The UEPKP group achieved a significantly better VAS score (0.6 ± 0.5 vs. 0.9 ± 0.8) and ODI (24.7 ± 3.1 vs. 27.5 ± 1.8) at the final follow-up visit than the BTPKP group (p < 0.05). The UEPKP group showed significantly worse radiological outcomes (anterior height rate and local kyphosis angle) at the 6- and 12-month follow-ups (p < 0.05). As for complications, the UEPKP group showed significantly fewer facet joint violations and intraspinal leakages (p < 0.05). Conclusion: UEPKP could be a safe and effective alternative procedure for patients with thoracolumbar osteoporotic vertebral compression fracture, which possesses an apparent advantage in reducing intraspinal leakage and facet joint violation over BTPKP.

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This study aims to understand the cognitive profiles of cerebellar infarction patients and compare them to those with supratentorial infarctions, particularly frontal infarctions. This current study also aims to find reliable assessment tools for detecting cognitive impairment in cerebellar infarction patients. A total of fifty cerebellar infarction patients, sixty supratentorial infarction patients, and thirty-nine healthy controls were recruited. The Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), Addenbrooke's Cognitive Examination III (ACE-III), and Cerebellar Cognitive Affective Syndrome scale (CCAS-s) were used to assess global cognitive function. An extensive neuropsychological assessment battery was also tested to evaluate the characteristics of each cognitive domain. To assess the features of cognitive function, a comprehensive neuropsychological evaluation tool was also utilized. The cerebral infarction patients demonstrated cognitive impairment comparable to those with frontal infarcts, notably characterized by disturbance in attention and executive function. However, the degree of cognitive impairment was comparatively milder in cerebellar infarction patients. Furthermore, the patients in the cerebellar group had worse scores in the ACE-III and CCAS-s compared to healthy controls. The two assessments also demonstrated a significant area under the curve values, indicating their effectiveness in distinguishing cognitive impairment in cerebellar infarctions. In conclusion, cognitive impairment in a cerebellar infarction resembles frontal lobe dysfunction but is generally mild. It can be accurately assessed using the ACE-III and CCAS-s scales.

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Recent work finds that upward neighborhood mobility-defined as reductions in neighborhood socioeconomic disadvantage due to moving-may improve birth outcomes. Less work, however, explores whether changes in socioeconomic context differentially impact birth outcomes by maternal race and ethnicity. In the US, mothers of minoritized racial and ethnic identity often experience worse neighborhood conditions and pregnancy outcomes than White mothers. Using a sibling-linked dataset, we examined whether neighborhood mobility corresponds with changes in preterm birth risk among Asian (N = 130,079), Black (N = 50,149), Hispanic (N = 429,938), and White (N = 233,428) mothers who delivered multiple live births in California between 2005 and 2015. We linked residential addresses at each birth to census-derived indices of neighborhood disadvantage and defined levels of neighborhood mobility as moving-induced changes in disadvantage between pregnancies. We mapped neighborhood mobility patterns and fit conditional logistic regression models estimating the odds of preterm birth in the sibling delivered after moving, controlling for the risk of preterm birth in the sibling delivered before moving, by maternal race and ethnicity. Dot density maps highlight racialized patterns of neighborhood mobility and segregation between Black and White mothers. Regression results show that Black and, in some cases, Asian and Hispanic mothers who experienced upward mobility (moves away from neighborhood disadvantage) exhibited reduced odds of preterm birth in the second delivery. Upward mobility did not reduce the odds of preterm birth among White mothers. Findings suggest that policies and programs that enable opportunities for neighborhood mobility may reduce persistent racial and ethnic disparities in adverse birth outcomes.

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Artificial intelligence (AI) is a suite of technologies that enables computers to learn and interpret information like human cognition. It has found applications across various fields, including healthcare, agriculture, astronomy, navigation, and robotics. Within healthcare, AI has the potential to enhance diagnostic accuracy, facilitate drug research, and automate patient experiences. This comparative study focuses on the proficiency of AI in generating accurate differential diagnoses in the field of pathology. Six medical vignettes were crafted, and each scenario was then input into three different AI platforms. The pathologist reviewed and determined the most accurate AI model.

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Identifying patients who benefit from a treatment is a key aspect of personalized medicine, which allows the development of individualized treatment rules (ITRs). Many machine learning methods have been proposed to create such rules. However, to what extent the methods lead to similar ITRs, that is, recommending the same treatment for the same individuals is unclear. In this work, we compared 22 of the most common approaches in two randomized control trials. Two classes of methods can be distinguished. The first class of methods relies on predicting individualized treatment effects from which an ITR is derived by recommending the treatment evaluated to the individuals with a predicted benefit. In the second class, methods directly estimate the ITR without estimating individualized treatment effects. For each trial, the performance of ITRs was assessed by various metrics, and the pairwise agreement between all ITRs was also calculated. Results showed that the ITRs obtained via the different methods generally had considerable disagreements regarding the patients to be treated. A better concordance was found among akin methods. Overall, when evaluating the performance of ITRs in a validation sample, all methods produced ITRs with limited performance, suggesting a high potential for optimism. For non-parametric methods, this optimism was likely due to overfitting. The different methods do not lead to similar ITRs and are therefore not interchangeable. The choice of the method strongly influences for which patients a certain treatment is recommended, drawing some concerns about their practical use.

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OBJECTIVE: Treatment of juxtarenal and complex neck abdominal aortic aneurysms (AAAs) is now commonly by endovascular rather than open surgical repair (OSR). Published comparisons show poor validity and scientific precision. UK-COMPASS is a comparative cohort study of endovascular treatments vs. OSR for patients with an AAA unsuitable for standard on label endovascular aneurysm repair (EVAR). METHODS: All procedures for AAA in England (November 2017 to October 2019) were identified, AAA anatomy assessed in a Corelab, peri-operative risk scores determined, and propensity scoring used to identify patients suitable for either endovascular treatment or OSR. Patients were stratified by aneurysm neck length (0 - 4 mm, 5 - 9 mm, or ≥ 10 mm) and operative risk; the highest quartile was considered high risk and the remainder standard risk. Death was the primary outcome measure. Endovascular treatments included fenestrated EVAR (FEVAR) and off label standard EVAR (± adjuncts). RESULTS: Among 8 994 patients, 2 757 had AAAs that were juxtarenal, short neck, or complex neck in morphology. Propensity score stratification and adjustment method comparisons included 1 916 patients. Widespread off label use of standard EVAR devices was noted (35.6% of patients). The adjusted peri-operative mortality rate was 2.9%, lower for EVAR (1.2%; p = .001) and FEVAR (2.2%; p = .001) than OSR (4.5%). In standard risk patients with a 0 - 4 mm neck, the mortality rate was 7.4% following OSR and 2.3% following FEVAR. Differences were smaller for patients with a neck length ≥ 5 mm: 2.1% OSR vs. 1.0% FEVAR. At 3.5 years of follow up, the overall mortality rate was 20.7% in the whole study population, higher following FEVAR (27.6%) and EVAR (25.2%) than after OSR (14.2%). However, in the 0 - 4 mm neck subgroup, overall survival remained equivalent. The aneurysm related mortality rate was equivalent between treatments, but re-intervention was more common after EVAR and FEVAR than OSR. CONCLUSION: FEVAR proves notably safer than OSR in the peri-operative period for juxtarenal aneurysms (0 - 4 mm neck length), with comparable midterm survival. For patients with short neck (5 - 9 mm) and complex neck (≥ 10 mm) AAAs, overall survival was worse in endovascularly treated patients compared with OSR despite relative peri-operative safety. This warrants further research and a re-appraisal of the current clinical application of endovascular strategies, particularly in patients with poor general survival outlook owing to comorbidity and age.

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Amyotrophic lateral sclerosis is a devastating neurodegenerative disease with a complex genetic basis, presenting both in familial and sporadic forms. The hexanucleotide (G4C2) repeat expansion in the C9orf72 gene, which triggers distinct pathogenic mechanisms, has been identified as a major contributor to familial and sporadic Amyotrophic lateral sclerosis cases. Animal models have proven pivotal in understanding these mechanisms; however, discrepancies between models due to variable transgene sequence, expression levels, and toxicity profiles complicate the translation of findings. Herein, we provide a systematic comparison of 7 publicly available Drosophila transgenes modeling the G4C2 expansion under uniform conditions, evaluating variations in their toxicity profiles. Further, we tested 3 previously characterized disease-modifying drugs in selected lines to uncover discrepancies among the tested strains. Our study not only deepens our understanding of the C9orf72 G4C2 mutations but also presents a framework for comparing constructs with minute structural differences. This work may be used to inform experimental designs to better model disease mechanisms and help guide the development of targeted interventions for neurodegenerative diseases, thus bridging the gap between model-based research and therapeutic application.

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BACKGROUND/OBJECTIVE: To compare the prehospital treatment modalities and intervention regimens for major trauma patients with comparable injury patterns between Austria and Germany. PATIENTS AND METHODS: This analysis is based on data retrieved from the TraumaRegister DGU®. Data included severely injured trauma patients with an injury severity score (ISS) ≥ 16, an age ≥ 16 years, and who were primarily admitted to an Austrian (n = 4186) or German (n = 41,484) level I trauma center (TC) from 2008 to 2017. Investigated endpoints included prehospital times and interventions performed until final hospital admission. RESULTS: The cumulative time for transportation from the site of the accident to the hospital did not significantly differ between the countries (62 min in Austria, 65 min in Germany). Overall, 53% of all trauma patients in Austria were transported to the hospital with a helicopter compared to 37% in Germany (p < 0.001). The rate of intubation was 48% in both countries, the number of chest tubes placed (5.7% Germany, 4.9% Austria), and the frequency of administered catecholamines (13.4% Germany, 12.3% Austria) were comparable (Φ = 0.00). Hemodynamic instability (systolic blood pressure, BP ≤ 90 mmHg) upon arrival in the TC was higher in Austria (20.6% vs. 14.7% in Germany; p < 0.001). A median of 500 mL of fluid was administered in Austria, whereas in Germany 1000 mL was infused (p < 0.001). Patient demographics did not reveal a relationship (Φ = 0.00) between both countries, and the majority of patients sustained a blunt trauma (96%). The observed ASA score of 3-4 was 16.8% in Germany versus 11.9% in Austria. CONCLUSION: Significantly more helicopter EMS transportations (HEMS) were carried out in Austria. The authors suggest implementing international guidelines to explicitly use the HEMS system for trauma patients only a) for the rescue/care of people who have had an accident or are in life-threatening situations, b) for the transport of emergency patients with ISS > 16, c) for transportation of rescue or recovery personnel to hard to reach regions or, d) for the transport of medicinal products, especially blood products, organ transplants or medical devices.

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At the beginning of a project or research that involves the issue of autonomous navigation of mobile robots, a decision must be made about working with traditional control algorithms or algorithms based on artificial intelligence. This decision is not usually easy, as the computational capacity of the robot, the availability of information through its sensory systems and the characteristics of the environment must be taken into consideration. For this reason, this work focuses on a review of different autonomous-navigation algorithms applied to mobile robots, from which the most suitable ones have been identified for the cases in which the robot must navigate in dynamic environments. Based on the identified algorithms, a comparison of these traditional and DRL-based algorithms was made, using a robotic platform to evaluate their performance, identify their advantages and disadvantages and provide a recommendation for their use, according to the development requirements of the robot. The algorithms selected were DWA, TEB, CADRL and SAC, and the results show that-according to the application and the robot's characteristics-it is recommended to use each of them, based on different conditions.

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Preference for noise reduction (NR) strength differs between individuals. The purpose of this study was (1) to investigate whether hearing loss influences this preference, (2) to find the number of distinct settings required to classify participants in similar groups based on their preference for NR strength, and (3) to estimate the number of paired comparisons needed to predict to which preference group a participant belongs. A paired comparison paradigm was used in which participants listened to pairs of speech-in-noise stimuli processed by NR with 10 different strength settings. Participants indicated their preferred sound sample. The 30 participants were divided into three groups according to hearing status (normal hearing, mild hearing loss, and moderate hearing loss). The results showed that (1) participants with moderate hearing loss preferred stronger NR than participants with normal hearing; (2) cluster analysis based solely on the preference for NR strength showed that the data could be described well by dividing the participants into three preference clusters; (3) the appropriate cluster membership could be found with 15 paired comparisons. We conclude that on average, a higher hearing loss is related to a preference for stronger NR, at least for our NR algorithm and our participants. The results show that it might be possible to use a limited set of pre-set NR strengths that can be chosen clinically. For our NR one might use three settings: no NR, intermediate NR, and strong NR. Paired comparisons might be used to find the optimal one of the three settings.

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BACKGROUND: Most breast reconstructions are implant-based and can be performed either in a one-stage, direct-to-implant or in a two-stage, expander-implant-based reconstruction. The objective of this systematic review is to compare the safety and patient satisfaction of the two reconstruction approaches. METHODS: A literature search was conducted on 27 September 2022 using various databases. Studies comparing one-stage and two-stage implant reconstructions and reporting the following outcomes were included: patient satisfaction, aesthetics, complications, and/or costs. Reviews, case reports, or series with less than 20 patients and letters or comments were excluded. Comparisons were made between the one-stage reconstruction with and without acellular dermal matrix (ADM) and two-stage implant-based breast reconstruction groups. The data extracted from all articles were analysed using random-effects meta-analyses. RESULTS: Of the 1381 records identified, a total of 33 articles were included, representing 21529 patients. There were no significant differences between the one-stage and two-stage groups, except for the costs. The one-stage operation without ADM had lower costs than the two-stage operation without ADM, although the use of an ADM substantially increased the price of the operation to more than a two-stage reconstruction. DISCUSSION: Equal patient satisfaction, aesthetic outcomes, and complication rates with lower costs justify one-stage breast reconstruction in carefully selected patients. This review shows that there is no evidence-based superior surgical approach. Future research should focus on the costs of the ADM versus an additional stage and patient-reported outcomes.

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Background: To explore the long-term relationship between maternal smoking during pregnancy and early childhood growth in the UK Biobank cohort. Methods: To estimate the effect of maternal smoking during pregnancy on offspring height and body size at ten years old, we performed binary logistic analyses and reported odds ratios (OR) as well as 95% confidence intervals (95%CIs). We also implemented the cross-contextual comparison study to examine whether such influence could be repeatedly observed among three different ethnicities in the UK Biobank cohort (n = 22,140 for White, n = 7094 for South Asian, and n = 5000 for Black). In particular, we conducted the sibling cohort study in White sibling cohort (n = 9953 for height and n = 7239 for body size) to control for unmeasured familial confounders. Results: We discovered that children whose mothers smoked during pregnancy had greater risk of being shorter or plumper at age ten in the full UK Biobank White cohort, with 15.3% (95% CIs: 13.0%∼17.7%) higher risk for height and 32.4% (95%CIs: 29.5%∼35.4%) larger risk for body size. Similar associations were identified in the South Asian and Black ethnicities. These associations were robust and remained significant in the White sibling cohort (12.6% [95%CIs: 5.0%∼20.3%] for height and 36.1% [95%CIs: 26.3%∼45.9%] for body size) after controlling for family factors. Conclusion: This study robustly confirms that maternal smoking during pregnancy can promote height deficit and obesity for offspring at ten years old. Our findings strongly encourage mothers to quit smoking during pregnancy for improving growth and development of offspring.

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Background Breathing motion management is the key to delivering stereotactic body radiation therapy (SBRT) for liver lesions. This study aimed to compare the dosimetric parameters of liver SBRT using two different techniques: free breathing and breath hold. Method The study included 11 patients with liver metastases or hepatocellular carcinoma who underwent liver-directed SBRT. A dosimetric comparison was performed using dose-volume histogram analysis, evaluating parameters such as the maximum dose to 5 cc of bowel volume, mean liver dose (MLD), and liver V20 and V30. Statistical analyses were performed to compare results. Results The findings revealed that the breath hold technique resulted in significantly lower doses to the bowel and smaller volumes of normal liver tissue receiving 20 Gy (V20) and 30 Gy (V30) than the free breathing. Although there was no statistically significant difference in the MLD between the two techniques, the breath hold technique resulted in a lower MLD. Conclusion This dosimetric comparison study suggests that the breath hold technique is associated with lower radiation exposure to the bowel and normal liver tissues. Although this may not be feasible for all patients, it may be an appropriate procedure for selected individuals. Further research is needed to validate these findings in different patient populations and explore their impact on clinical outcomes and patient-reported quality of life.

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Concentrations of extracellular vesicles (EVs) in body fluids are being explored as disease biomarkers. Most laboratories use flow cytometry to characterize single EVs at high throughput. A flow cytometer (FCM) detects light scattering and fluorescence intensities of EVs. However, detection of EVs by flow cytometry is complicated for 2 reasons. First, EVs are small and have weak light scattering and fluorescence signals compared to cells and are, therefore, hard to detect. Second, FCMs differ in sensitivity and provide data in arbitrary units, which complicates data interpretation. Due to the mentioned challenges, the measured concentration of EVs by flow cytometry is cumbersome to compare between FCMs and institutes. To improve comparability, standardization and development of traceable reference materials to calibrate all aspects of an FCM are needed, as are interlaboratory comparison studies. Within this article, we will provide an overview of the standardization of EV concentration measurements, including the current effort to introduce robust calibration of FCMs, thereby enabling comparable concentration measurements of EVs, which in turn can be used to establish clinically relevant reference ranges of EV concentrations in blood plasma and other body fluids.

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PURPOSE: The importance of lateral pelvic lymph node dissection (LLND) for advanced low rectal cancer is gradually being recognized in Europe and the USA, where some patients were affected by uncontrolled lateral pelvic lymph node (LLNs) metastasis, even after total mesorectal excision (TME) with neoadjuvant chemoradiotherapy (CRT). The purpose of this study was thus to compare robotic LLND (R-LLND) with laparoscopic (L-LLND) to clarify the safety and advantages of R-LLND. METHODS: Sixty patients were included in this single-institution retrospective study between January 2013 and July 2022. We compared the short-term outcomes of 27 patients who underwent R-LLND and 33 patients who underwent L-LLND. RESULTS: En bloc LLND was performed in significantly more patients in the R-LLND than in the L-LLND group (48.1% vs. 15.2%; p = 0.006). The numbers of LLNs on the distal side of the internal iliac region (LN 263D) harvested were significantly higher in the R-LLND than in the L-LLND group (2 [0-9] vs. 1 [0-6]; p = 0.023). The total operative time was significantly longer in the R-LLND than in the L-LLND group (587 [460-876] vs. 544 [398-859]; p = 0.003); however, the LLND time was not significantly different between groups (p = 0.718). Postoperative complications were not significantly different between the two groups. CONCLUSION: The present study clarified the safety and technical feasibility of R-LLND with respect to L-LLND. Our findings suggest that the robotic approach offers a key advantage, allowing significantly more LLNs to be harvested from the distal side of the internal iliac region (LN 263D). Prospective clinical trials examining the oncological superiority of R-LLND are thus necessary in the near future.

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BACKGROUND: Basic life support (BLS) education is essential for improving bystander cardiopulmonary resuscitation (CPR) rates, but the imparting of such education faces obstacles during the outbreak of emerging infectious diseases, such as COVID-19. When face-to-face teaching is limited, distance learning-blended learning (BL) or an online-only model-is encouraged. However, evidence regarding the effect of online-only CPR training is scarce, and comparative studies on classroom-based BL (CBL) are lacking. While other strategies have recommended self-directed learning and deliberate practice to enhance CPR education, no previous studies have incorporated all of these instructional methods into a BLS course. OBJECTIVE: This study aimed to demonstrate a novel BLS training model-remote practice BL (RBL)-and compare its educational outcomes with those of the conventional CBL model. METHODS: A static-group comparison study was conducted. It included RBL and CBL courses that shared the same paradigm, comprising online lectures, a deliberate practice session with Little Anne quality CPR (QCPR) manikin feedback, and a final assessment session. In the main intervention, the RBL group was required to perform distant self-directed deliberate practice and complete the final assessment via an online video conference. Manikin-rated CPR scores were measured as the primary outcome; the number of retakes of the final examination was the secondary outcome. RESULTS: A total of 52 and 104 participants from the RBL and CBL groups, respectively, were eligible for data analysis. A comparison of the 2 groups revealed that there were more women in the RBL group than the CBL group (36/52, 69.2% vs 51/104, 49%, respectively; P=.02). After adjustment, there were no significant differences in scores for QCPR release (96.9 vs 96.4, respectively; P=.61), QCPR depth (99.2 vs 99.5, respectively; P=.27), or QCPR rate (94.9 vs 95.5, respectively; P=.83). The RBL group spent more days practicing before the final assessment (12.4 vs 8.9 days, respectively; P<.001) and also had a higher number of retakes (1.4 vs 1.1 times, respectively; P<.001). CONCLUSIONS: We developed a remote practice BL-based method for online-only distant BLS CPR training. In terms of CPR performance, using remote self-directed deliberate practice was not inferior to the conventional classroom-based instructor-led method, although it tended to take more time to achieve the same effect. TRIAL REGISTRATION: Not applicable.

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Reference materials (RMs) are vital tools in the validation of methods used to detect environmental pollutants. Microplastics, a relatively new environmental pollutant, require a variety of complex approaches to address their presence in environmental samples. Both interlaboratory comparison (ILC) studies and RMs are essential to support the validation of methods used in microplastic analysis. Presented here are results of quality assurance and quality control (QA/QC) performed on two types of candidate microplastic RMs: dissolvable gelatin capsules and soda tablets. These RMs have been used to support numerous international ILC studies in recent years (2019-2022). Dissolvable capsules containing polyethylene terephthalate (PET), polyvinyl chloride (PVC), polyethylene (PE), and polystyrene (PS), in different size fractions from 50 to 1000 µm, were produced for one ILC study, obtaining relative standard deviation (RSD) from 0 to 24%. The larger size fraction allowed for manual addition of particles to the capsules, yielding 0% error and 100% recovery during QA/QC. Dissolvable capsules were replaced by soda tablets in subsequent ILC studies and recovery test exercises because they were found to be a more reliable carrier for microplastic RMs. Batches of soda tablets were produced containing different single and multiple polymer mixtures, i.e., PE, PET, PS, PVC, polypropylene (PP), and polycarbonate (PC), with RSD ranging from 8 to 21%. Lastly, soda tablets consisting of a mixture of PE, PVC, and PS (125-355 µm) were produced and used for recovery testing during pretreatment of environmental samples. These had an RSD of 9%. Results showed that soda tablets and capsules containing microplastics >50 µm could be produced with sufficient precision for internal recovery tests and external ILC studies. Further work is required to optimize this method for smaller microplastics (< 50 µm) because variation was found to be too large during QA/QC. Nevertheless, this approach represents a valuable solution addressing many of the challenges associated with validating microplastic analytical methods.

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AIMS/HYPOTHESIS: The Islet Autoantibody Standardization Program (IASP) aims to improve the performance of immunoassays measuring autoantibodies in type 1 diabetes and the concordance of results across laboratories. IASP organises international workshops distributing anonymised serum samples to participating laboratories and centralises the collection and analysis of results. In this report, we describe the results of assays measuring IAA submitted to the IASP 2018 and 2020 workshops. METHODS: The IASP distributed uniquely coded sera from individuals with new-onset type 1 diabetes, multiple islet autoantibody-positive individuals, and diabetes-free blood donors in both 2018 and 2020. Serial dilutions of the anti-insulin mouse monoclonal antibody HUI-018 were also included. Sensitivity, specificity, area under the receiver operating characteristic curve (ROC-AUC), partial ROC-AUC at 95% specificity (pAUC95) and concordance of qualitative/quantitative results were compared across assays. RESULTS: Results from 45 IAA assays of seven different formats and from 37 IAA assays of six different formats were submitted to the IASP in 2018 and 2020, respectively. The median ROC-AUC was 0.736 (IQR 0.617-0.803) and 0.790 (IQR 0.730-0.836), while the median pAUC95 was 0.016 (IQR 0.004-0.021) and 0.023 (IQR 0.014-0.026) in the 2018 and 2020 workshops, respectively. Assays largely differed in AUC (IASP 2018 range 0.232-0.874; IASP 2020 range 0.379-0.924) and pAUC95 (IASP 2018 and IASP 2020 range 0-0.032). CONCLUSIONS/INTERPRETATION: Assay formats submitted to this study showed heterogeneous performance. Despite the high variability across laboratories, the in-house radiobinding assay (RBA) remains the gold standard for IAA measurement. However, novel non-radioactive IAA immunoassays showed a good performance and, if further improved, might be considered valid alternatives to RBAs.

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This study reports a clinical evaluation of AiDEX CGM system featuring a 14-day sensor, real-time glucose monitoring and factory-calibration. A multicenter, prospective, masked clinical study was conducted at with a total of 120 participants. Each participant wore 4 studied sensors and had one in-clinic visit for venous blood reference tests. 40 out of the 120 participants wore additional Abbott Libre sensors and performed at least 7 capillary BG tests daily for additional reference and comparison. Continuous glucose error grid analysis (CG-EGA) showed that AiDEX and Abbott Libre had good agreement with venous blood glucose, with 98.69% and 98.96% accurate readings, respectively. Overall MARD of AiDEX CGM systems was 9.08% when compared to venous blood reference and 10.1% when compared to finger capillary BG reference.

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