Loyola Generativity Scale e Generative Behavior Checklist: Um estudo psicométrico com idosos espanhóis LGBT+ / Loyola Generativity Scale and Generative Behavior Checklist: A Psychometric Study with Spanish LGBT+ Older Adults / Loyola Generativity Scale y Generative Behavior Checklist: Un estudio psicométrico con personas mayores españolas LGBT+

Resumo Enquadramento: A generatividade tem sido associada à resiliência e à satisfação com a vida na velhice, incluindo entre a população lésbica, gay, bissexual e transgénero (LGBT+) mais velha. Objetivo: Analisar as propriedades psicométricas da Loyola Generativity Scale (LGS) e da Generative Behavior Checklist (GBC) para idosos espanhóis LGBT + (com mais de 50 anos). Metodologia: Foi realizado um estudo psicométrico com 141 idosos espanhóis LGBT+ com o objetivo de examinar a validade de construto (análise fatorial exploratória), a validade convergente e a fiabilidade (consistência interna) da LGS e da GBC. Resultados: Os métodos de análise paralela e a análise fatorial exploratória sugeriram um modelo de dois fatores para ambos os instrumentos com boa adequação da amostra. A LGS explicou 45,1% da variância e apresentou uma consistência interna de 0,78. O GBC explicou 41,76% da variância e apresentou uma consistência interna de 0,879. Foi encontrada uma correlação positiva e estatisticamente significativa entre a satisfação com a vida e as escalas generativas. Foi também observada uma correlação positiva e significativa (rs = 0,310) entre os dois instrumentos. Conclusão: Ambos os instrumentos demonstraram ser válidos e fiáveis para medir a generatividade em idosos espanhóis LGBT+.

Abstract Background: Generativity has been associated with resilience and life satisfaction in older age, including among lesbian, gay, bisexual, and transgender (LGBT+) older adults. Objective: To examine the psychometric properties of the Loyola Generativity Scale (LGS) and Generative Behavior Checklist (GBC) for Spanish LGBT+ older adults (over the age of 50). Methodology: A psychometric study was conducted with 141 Spanish LGBT+ older adults to examine the construct validity (exploratory factor analysis), convergent validity, and reliability (internal consistency) of the LGS and the GBC. Results: Parallel and exploratory factor analyses suggested a two-factor model with good sample adequacy for both scales. The LGS explained 45.1% of the variance and had an internal consistency of 0.78. The GBC explained 41.76 % of the variance and had an internal consistency of 0.879. A positive and statistically significant correlation was found between life satisfaction and the generative scales. A positive and significant correlation (rs = 0.310) was also observed between both instruments. Conclusion: Both instruments proved valid and reliable for measuring generativity in Spanish LGBT+ older adults.

Resumen Marco contextual: La generatividad se asocia con la resiliencia y la satisfacción con la vida en la vejez, incluidas las de las personas adultas lesbianas, gays, bisexuales y transexuales (LGBT+). Objetivo: Examinar las propiedades psicométricas de la Loyola Generativity Scale (LGS) y la Generative Behavior Checklist (GBC) en adultos mayores LGBT+ españoles (mayores de 50 años). Metodología: Estudio psicométrico con 141 adultos mayores LGBT+. Se analizó la validez de constructo (análisis factorial exploratorio), la validez convergente y la consistencia interna de cada escala. Resultado: Los análisis factoriales paralelos y exploratorios sugieren un modelo bifactorial para ambas escalas con una buena adecuación a la muestra. La LGS explica el 45,1% de la varianza y tiene una consistencia interna de 0,78. La GBC explica el 41,76% de la varianza y tiene una consistencia interna de 0,879. Se encontró una correlación positiva estadísticamente significativa entre la satisfacción con la vida y las escalas de generatividad. Las dos escalas mostraron una correlación positiva y significativa (rs = 0,310). Conclusión: Ambas escalas han demostrado ser válidas y fiables para medir la generatividad en adultos mayores LGBT+ españoles.

Hospitalizaciones evitables por problemas de salud sensibles a cuidados ambulatorios: construcción y validación de la lista Uruguaya de patologías

Introducción: Las hospitalizaciones por Ambulatory Care Sensitive Conditions es un indicador que mide la utilización de los servicios hospitalarios por problemas de salud que podrían haber sido prevenidos en el primer nivel de atención. El concepto se refiere a los procesos en que la atención ambulatoria efectiva puede ayudar a disminuir los riesgos de hospitalización, en un segundo nivel de atención. El objetivo del estudio fue construir y validar una lista uruguaya de problemas de salud sensibles a cuidados ambulatorios (PSSCA) según CIE-10. Metodología: Para la construcción de la lista inicial de códigos de PSSCA se realizó una revisión de los listados existentes y se propuso un listado inicial que fue validado a través del Método Delphi. Se propone un listado de 99 códigos diagnósticos de PSSCA adaptado a nuestro entono sanitario. Los mismos permiten identificar y cuantificar problemas de salud que pueden producir hospitalizaciones potenciamente evitables mediante cuidados ambulatorios accesibes y oportunos en el primer nivel de atención. Resultados: Se conformó un panel de 12 expertos. A partir de los datos obtenidos, considerando los 99 diagnósticos clasificados por CIE-10, éstos se pueden subclasificar en función de si la patología es infecciosa o no, obteniendo un resultado general de 62 patologías en un total de 99 que pueden ser clasificadas como infecciosas, lo que se corresponde a un 62 %. Discusión: De la comparación de la lista uruguaya de PSSCA a la que hemos arribado y las listas validadas utilizadas para la construcción inicial del listado de patologías propuesto, podemos decir que la primera presenta un mayor porcentaje de coincidencia con la lista de patologías de Bello Horizonte. Podemos mencionar que la mayoría de los problemas de salud identificados con base en el listado de PSSCA, son sensibles de ser resueltos con la atención primaria oportuna y de calidad que podría evitar o disminuir de una manera significativa su hospitalización. Conclusiones: Este trabajo describe el proceso de construcción y validación de una lista de códigos de PSSCA adaptados al contexto uruguayo a través del método Delphi. Hemos arribado a un listado que comprende un total de 99 diagnósticos, agrupadas en un total de diecinueve categorías que considera la especificidad del contexto uruguayo del indicador.

Introduction: Hospitalizations for Ambulatory Care Sensitive Conditions is an indicator that measures the use of hospital services for health problems that could have been prevented at the first level of care. The concept refers to the processes in which effective outpatient care can help reduce the risks of hospitalization, at a second level of care. The objective of the study was to build and validate a Uruguayan list of health problems sensitive to outpatient care (PSS-CA) according to ICD-10. Methodology: To construct the initial list of PSSCA codes, a review of the existing lists was carried out and an initial list was proposed that was validated through the Delphi Method. A list of 99 PSSCA diagnostic codes adapted to our healthcare environment is proposed. They make it possible to identify and quantify health problems that can lead to potentially avoidable hospitalizations through accessible and timely outpatient care at the first level of care. Results: A panel of 12 experts was formed. From the data obtained, considering the 99 diagnoses classified by ICD-10, these can be subclassified depending on whether the pathology is infectious or not, obtaining a general result of 62 pathologies in a total of 99 that can be classified as infectious, which corresponds to 62%. Discussion: From the comparison of the Uruguayan list of PSSCA that we have arrived at and the validated lists used for the initial construction of the proposed list of pathologies, we can say that the first presents a higher percentage of coincidence with the list of pathologies of Bello Horizonte . We can mention that most of the health problems identified based on the PSSCA list are sensitive to being resolved with timely and quality primary care that could prevent or significantly reduce hospitalization. Conclusions: This work describes the process of construction and validation of a list of PSSCA codes adapted to the Uruguayan context through the Delphi method. We have arrived at a list that includes a total of 99 diagnoses, grouped into a total of nineteen categories that consider the specificity of the Uruguayan context of the indicator.

Introdução: As Internações por Condições Sensíveis à Atenção Ambulatorial são um indicador que mede a utilização de serviços hospitalares para problemas de saúde que poderiam ter sido evitados no primeiro nível de atenção. O conceito refere-se aos processos em que um atendimento ambulatorial eficaz pode auxiliar na redução dos riscos de internação, em um segundo nível de atenção. O objetivo do estudo foi construir e validar uma lista uruguaia de problemas de saúde sensíveis à atenção ambulatorial (PSS-CA) segundo a CID-10. Metodologia: Para construir a lista inicial de códigos PSSCA foi realizada uma revisão das listas existentes e foi proposta uma lista inicial que foi validada através do Método Delphi. É proposta uma lista de 99 códigos de diagnóstico PSSCA adaptados ao nosso ambiente de saúde. Permitem identificar e quantificar problemas de saúde que podem levar a hospitalizações potencialmente evitáveis ​​através de cuidados ambulatórios acessíveis e oportunos no primeiro nível de cuidados. Resultados: Foi formado um painel de 12 especialistas. A partir dos dados obtidos, considerando os 99 diagnósticos classificados pela CID-10, estes podem ser subclassificados consoante a patologia seja infecciosa ou não, obtendo-se um resultado geral de 62 patologias num total de 99 que podem ser classificadas como infecciosas, o que corresponde para 62%. Discussão: A partir da comparação da lista uruguaia de PSSCA a que chegamos e das listas validadas utilizadas para a construção inicial da lista de patologias proposta, podemos dizer que a primeira apresenta um maior percentual de coincidência com a lista de patologias de Belo Horizonte. Podemos mencionar que a maioria dos problemas de saúde identificados com base na lista PSSCA são sensíveis para serem resolvidos com cuidados primários oportunos e de qualidade que possam prevenir ou reduzir significativamente a hospitalização. Conclusões: Este trabalho descreve o processo de construção e validação de uma lista de códigos PSSCA adaptados ao contexto uruguaio através do método Delphi. Chegamos a uma lista que inclui um total de 99 diagnósticos, agrupados em um total de dezenove categorias que consideram a especificidade do contexto uruguaio do indicador.

Psychometric properties of the Spanish version of the Chalder Fatigue Scale in clinical and general populations / Propiedades psicométricas de la versión española de la Escala de Fatiga de Chalder en población clínica y general

Objetivo: La Escala de Fatiga de Chalder (CFS) es una escala breve para evaluar fatiga que se utiliza en España, pero que no ha sido validada en su población. El objetivo del estudio fue adaptar y evaluar las propiedades psicométricas de la versión española de la CFS (Sp-CFS). Método: La muestra la conformaron 3,671 participantes (3.190 de la población general y 481 pacientes), con edades entre 18 y 86 años (M = 28.43; DT = 12.71), siendo el 67.6% mujeres. Las propiedades psicométricas de la escala se probaron en un diseño transversal utilizando validación cruzada (análisis factorial exploratorio y confirmatorio) y estimación de la invarianza (sexo y condición clínica). Resultados: Un modelo de cuatro factores (baja energía, problemas de sueño, problemas de concentración y disfunción cognitiva subjetiva) en lugar de un modelo original de dos factores (fatiga física y mental) proporcionó mejores índices de bondad de ajuste a los datos. La consistencia interna y la estabilidad de la escala fueron excelentes. Su validez convergente se apoyó en su asociación significativa con la ansiedad, la depresión, el estrés y los síntomas positivos y negativos del espectro de la psicosis. El instrumento no mostró diferencias significativas entre sexos ni condiciones clínicas, y discriminó entre la población general y los pacientes, obteniendo estos últimos puntajes significativamente mayores. Conclusiones: Sp-CFS es una escala fiable y válida para medir la fatiga en población general y clínica española.(AU)

Objective:The Chalder Fatigue Scale (CFS) is a brief self-report screening scale for fatigue that is used in Spain but has not been validated for the Spanish population. The aim of this study was to adapt and evalu-ate the psychometric properties of the Spanish version of the CFS (Sp-CFS). Method:The sample consisted of 3,671 participants (3,190 from the general population and 481 patients), aged 18 to 86 years (M=28.43; DT=12.71), 67.6% of whom were women. Psychometric properties of the scale were tested in a cross-sectional design using cross-validation (explora-tory and confirmatory factor analysis) and estimation of invariance (sex and clinical condition). Results:A four-factor model (low energy, sleep problems, concentration problems and subjective cognitive dysfunction) rather than an original two-factor model (physical and mental fatigue) pro-vided better indices of goodness of fit to the data. The internal consistencyand stability of the scale were excellent. Its convergent validity was sup-ported by its significant association with anxiety, depression, stress, and the positive and negative symptoms of the psychosis spectrum. The instru-ment did not show significant differences between sexes or clinical condi-tions, and it discriminated between the general population and the patients, with the latter obtaining significantly greater scores. Conclusions: Sp-CFS is a reliable and valid scale for measuring a transdiagnostic construct such as fatigue in Spanish general and clinical populations.(AU)

A guide to selecting high-performing antibodies for Synaptotagmin-1 (Uniprot ID P21579) for use in western blot, immunoprecipitation, immunofluorescence and flow cytometry.

Synaptotagmin-1 is a synaptic vesicle transmembrane protein that senses calcium influx via its tandem C2-domains, triggering synchronous neurotransmitter release. Disruption to SYT1 is associated with neurodevelopmental disorders, highlighting the importance of identifying high-quality research reagents to enhance understanding of Synaptotagmin-1 in health and disease. Here we have characterized thirteen Synaptotagmin-1 commercial antibodies for western blot, immunoprecipitation, immunofluorescence and flow cytometry using a standardized experimental protocol based on comparing read-outs in knockout cell lines and isogenic parental controls. These studies are part of a larger, collaborative initiative seeking to address antibody reproducibility issues by characterizing commercially available antibodies for human proteins and publishing the results openly as a resource for the scientific community. While use of antibodies and protocols vary between laboratories, we encourage readers to use this report as a guide to select the most appropriate antibodies for their specific needs.

[Development and Validation of a Risk Prediction Model for Prolonged Hospitalization in Patients With Diabetic Foot Ulcers]. / ç³–å°¿ç— è¶³æºƒç–¡æ‚£è€ ä½é™¢æ—¶é—´å»¶é•¿é£Žé™©é¢„æµ‹æ¨¡åž‹æž„å»ºåŠéªŒè¯.

Objective: To investigate the risk factors associated with prolonged hospitalization in patients diagnosed with diabetic foot ulcers (DFU), to develop a predictive model, and to conduct internal validation of the model. Methods: The clinical data of DFU patients admitted to West China Hospital, Sichuan University between January 2012 and December 2022 were retrospectively collected. The subjects were randomly assigned to a training cohort and a validation cohort at a ratio of 7 to 3. Hospital stays longer than 75th percentile were defined as prolonged length-of-stay. A thorough analysis of the risk factors was conducted using the training cohort, which enabled the development of an accurate risk prediction model. To ensure robustness, the model was internally validated using the validation cohort. Results: A total of 967 inpatients with DFU were included, among whom 245 patients were identified as having an extended length-of-stay. The training cohort consisted of 622 patients, while the validation cohort comprised 291 patients. Multivariate logistic regression analysis revealed that smoking history (odds ratio [OR]=1.67, 95% confidence interval [CI], 1.13 to 2.48, P=0.010), Wagner grade 3 or higher (OR=7.13, 95% CI, 3.68 to 13.83, P<0.001), midfoot ulcers (OR=1.99, 95% CI, 1.07 to 3.72, P=0.030), posterior foot ulcers (OR=3.68, 95% CI, 1.83 to 7.41, P<0.001), multisite ulcers (OR=2.91, 95% CI, 1.80 to 4.69, P<0.001), wound size≥3 cm2 (OR=2.00, 95% CI, 1.28-3.11, P=0.002), and white blood cell count (OR=1.11, 95% CI, 1.05 to 1.18, P<0.001) were associated with an increased risk of prolonged length of stay. Additionally, a nomogram was constructed based on the identified risk factors. The areas under the receiver operating characteristic (ROC) curves for both the training cohort and the validation cohort were 0.782 (95% CI, 0.745 to 0.820) and 0.756 (95% CI, 0.694 to 0.818), respectively, indicating robust predictive performance. Furthermore, the calibration plot demonstrated optimal concordance between the predicted probabilities and the observed outcomes in both the training and the validation cohorts. Conclusion: Smoking history, Wagner grade≥3, midfoot ulcers, posterior foot ulcers, multisite ulcers, ulcer area≥3 cm2, and elevated white blood cell count are identified as independent predictors of prolonged hospitalization. Therefore, it is imperative that clinicians conduct a comprehensive patient evaluation and implement appropriate diagnostic and therapeutic strategies to effectively shorten the length of stay for DFU patients.

Unpacking WHO and CDC Bottle Bioassay Methods: A Comprehensive Literature Review and Protocol Analysis Revealing Key Outcome Predictors.

Background: Resistance monitoring is a key element in controlling vector-borne diseases. The World Health Organization (WHO) and Centres for Disease Control and Prevention (CDC) have each developed bottle bioassay methods for determining insecticide susceptibility in mosquito vectors which are used globally. Methods: This study aimed to identify variations in bottle bioassay methodologies and assess the potential impact on the data that is generated. Our approach involved a systematic examination of existing literature and protocols from WHO and CDC, with a focus on the specifics of reported methodologies, variation between versions, and reported outcomes. Building on this, we experimentally evaluated the impact of several variables on bioassay results. Results: Our literature review exposed a significant inconsistency in the how bioassay methods are reported, hindering reliable interpretation of data and the ability to compare results between studies. The experimental research provided further insight by specifically identifying two key factors that influence the outcomes of bioassays: mosquito dry weight and relative humidity (RH). This finding not only advances our comprehension of these assays but also underscores the importance of establishing precisely defined methodologies for resistance monitoring. The study also demonstrates the importance of controlling bioassay variables, noting the significant influence of wing length, as an indicator of mosquito size, on mortality rates in standardized bioassays. Conclusions: Generating data with improved protocol consistency and precision will not only deepen our understanding of resistance patterns but also better inform vector control measures. We call for continued research and collaboration to refine and build consensus on bioassay techniques, to help bolster the global effort against vector-borne diseases like malaria.

Development and validation of a PMA-qPCR method for accurate quantification of viable Lacticaseibacillus paracasei in probiotics.

The effectiveness of probiotic products hinges on the viability and precise quantification of probiotic strains. This study addresses this crucial requirement by developing and validating a precise propidium monoazide combination with quantitative polymerase chain reaction (PMA-qPCR) method for quantifying viable Lacticaseibacillus paracasei in probiotic formulations. Initially, species-specific primers were meticulously designed based on core genes from the whole-genome sequence (WGS) of L. paracasei, and they underwent rigorous validation against 462 WGSs, 25 target strains, and 37 non-target strains across various taxonomic levels, ensuring extensive inclusivity and exclusivity. Subsequently, optimal PMA treatment conditions were established using 25 different L. paracasei strains to effectively inhibit dead cell DNA amplification while preserving viable cells. The developed method exhibited a robust linear relationship (R 2 = 0.994) between cycle threshold (Cq) values and viable cell numbers ranging from 103 to 108 CFU/mL, with an impressive amplification efficiency of 104.48% and a quantification limit of 7.30 × 103 CFU/mL. Accuracy assessments revealed biases within ±0.5 Log10 units, while Bland-Altman analysis demonstrated a mean bias of 0.058 Log10, with 95% confidence limits of -0.366 to 0.482 Log10. Furthermore, statistical analysis (p = 0.76) indicated no significant differences between theoretical and measured values. This validated PMA-qPCR method serves as a robust and accurate tool for quantifying viable L. paracasei in various sample matrices, including pure cultures, probiotics as food ingredients, and composite probiotic products, thereby enhancing probiotic product quality assurance and contributing to consumer safety and regulatory compliance.

Development of a high-performance liquid chromatography method for simultaneous quantification of sixteen polyphenols and application to tomato.

The main purpose of the current work was to develop a new method to evaluate and quantify sixteen polyphenol compounds from tomato fruit using high-performance liquid chromatography (HPLC). The separation of 16 polyphenols from tomato fruit was achieved in < 60 min by using a Waters Symmetry C18 column (250 × 4.6 mm i. d, 5 µm particle sizes) with a gradient system of ultrapure water (1 % acetic acid) and 100 % methanol, a temperature of 30 °C, an injection volume of 10 µL and a flow rate of 1.1 mL/min, respectively. The analytical characteristics of evaluation method provide sufficient sensitivity for all tomato polyphenols compounds within normal range 0.1-20 µg·mL-1 (R2≥0.999) with 0.069-0.365 µg·mL-1 LOD, and 0.171-1.106 µg·mL-1 LOQ, with good system suitability (<2 % RSD of retention time, peak area, and tailing factor, 6,000-1,336,000 N, and >1.5 peak resolution), <10 % RSD of precision, stability, repeatability, and robustness, and 99.2 - 105.0 % of recovery. The applicability of this method was demonstrated by the determination of polyphenols in nine cultivars of tomatoes. The results showed that '184' possessed the highest content of total polyphenols (1249.53 µg·g-1 DW) followed by 'Disease resistance 184' (1064.93 µg·g-1 DW). The main polyphenol components were rutin, quercetin, gallic acid, chlorogenic acid, 2,5-dihydroxy benzoic acid, caffeic acid and benzoic acid in tomato fruits. In conclusion, this novel HPLC method is useful and acceptable to analyze polyphenols in tomato fruit.

Design and validation of an instrument to evaluate Person-Centered care in health services.

BACKGROUND: The concept of quality in health care has evolved, placing greater importance on the patient's needs, culture, and social context, as well as their participation in clinical decision-making, as highlighted by Mead and Bower's Person-Centered Care Model. The aim of the present study was to design and validate an instrument to assess the extent to which healthcare services provided by PEMEX (Petróleos Mexicanos) offer person-centered care according to user perceptions. METHODS: The first phase comprised the development of 57 items based on the analysis of responses from an open-ended questionnaire administered to 30 users of Pemex healthcare services. This questionnaire was designed considering the four factors of the person-centered care model, however, the high correlation between the 4 factors (i.e., r ≥ .80) indicated an overfactoring effect and consequently an increase in the risk of overfitting. Therefore, an exhaustive analysis of the instrument was performed, starting with the review of the individual behavior of each item, and carrying out exploratory and confirmatory factor analysis. Using a sample of 330 individuals, an exploratory factor analysis was perfomed. Afterward, a confirmatory factorial analysis was carried out with 335 participants. Finally, a new confirmatory factorial analysis included 130 participants due to the refinements made in the previous phase. Internal consistency was assessed using Cronbach's α and McDonald's ω at every phase. RESULTS: The exploratory factor analysis retained 35 items in a single factor that accounted for 49% of the variance with an internal consistency of Cronbach's α and McDonald's ω = 0.97. Because the factorial structure by confirmatory factorial analysis was unsatisfactory, the initial model was refined, leading to the retention of 11 items and a final model with adjustment index of χ2 = 127.53, χ2/gl = 2.89, RMSEA = 0.07, IC RMSEA 0.06 to 0.09, TLI = 0.95 and CFI = 0.96, with an internal consistency of Cronbach's α and McDonald's ω = 0.93. Due to the refinements, a new confirmatory factorial analysis was conducted with suitable goodness-of-fit criteria in most items (χ2 = 151.44, χ2/gl = 3.43, RMSEA = 0.13, IC RMSEA 0.11 to 0.16, TLI = 0.93 and CFI = 0.94), resulting in a Cronbach's α and McDonald's ω = 0.98. CONCLUSIONS: The instrument exhibits suitable psychometric properties to be employed to measure the degree to which medical care is patient centered. This instrument represents a strategy for promoting an innovative healthcare model.

Antibody characterization is critical to enhance reproducibility in biomedical research.

Antibodies are used in many areas of biomedical and clinical research, but many of these antibodies have not been adequately characterized, which casts doubt on the results reported in many scientific papers. This problem is compounded by a lack of suitable control experiments in many studies. In this article we review the history of the 'antibody characterization crisis', and we document efforts and initiatives to address the problem, notably for antibodies that target human proteins. We also present recommendations for a range of stakeholders - researchers, universities, journals, antibody vendors and repositories, scientific societies and funders - to increase the reproducibility of studies that rely on antibodies.

Development and validation of enzyme-linked immunosorbent assay for anti-mouse pertussis immunoglobulin G using international reference anti-Bordetella pertussis mouse serum NIBSC 97/642.

Purpose: In this study, an in-house enzyme-linked immunosorbent assay (ELISA) was developed and validated. The titer of ELISA was calculated using the reference line (RFL) method based on the standard curve drawn using the international reference anti-mouse serum NIBSC (National Institute for Biological Standards and Control) 97/642. Materials and Methods: In the development step, signal to noise was depicted to select the buffers that showed the most appropriate ratio. In the validation step, standard range, precision, dilution linearity, and specificity were confirmed, and RFL and parallel line (PLL) methods were compared in precision and dilution linearity. Results: Coating concentration for plate was achieved at 0.1 µg/mL for pertussis toxin (PT), 0.15 µg/mL for filamentous hemagglutinin antigen (FHA), and 0.25 µg/mL for pertactin (PRN). The signal to noise ratio was 22.02 for PT, 14.93 for FHA, and 8.02 for PRN with 0.25% goat serum in phosphate-buffered saline (PBS) as a dilution buffer, and 2% skim milk in PBS as a blocking buffer. Based on the precision results, we assessed the lower limit of quantification by 1, 0.2, and 1.5 EU/mL concentration for PT, FHA, and PRN which met the ICH (International Council for Harmonization) M10 criteria of a 25% accuracy and total error of 40%. In specificity, homologous serum was spiked into heterologous serum and the accuracy met the criteria. There was no difference in the results between RFL and PLL calculations (p-value=0.3207 for PT, 0.7394 for FHA, 0.2109 for PRN). Conclusion: ELISA validated with RFL calculation method in this study is a relatively accurate assay for mouse humoral immunogenicity test.

Field validation as a means for continual monitoring of approved test kit's fitness for purpose in the commercial market.

Testing accuracy of a chemical contaminant requires use of a testing platform that conforms to validation criteria outlined in quality literature and standards. This study explores the application of commercial field data measured by qualified analysts using a United States Department of Agriculture - Federal Grain Inspection Service approved kit for measuring fumonisin in maize to augment method validation procedures. Analysts from seven grain testing facilities were qualified in official USDA sampling, sample preparation, and testing methodology using the Charm LF-FUMQ-WETS5. A duplicate sample was tested in the Office of the Texas State Chemist (OTSC) laboratory using UPLC-MS-MS. Data were subject to four statistical techniques using continuous and categorical methodology. This approach enabled researchers to explore if a single test or multiple comparisons were best suited to assess a field kit's fitness for purpose across facility, toxin level, and year. The study concluded that a paired t-test and correlation analysis provided a quick and meaningful evaluation of kit performance. The correct placement of samples within the correct bin (violative versus non-violative) aligns well with market forces and regulatory compliance. The results of this study also provide a useful tool to assess all field kits' performance at the beginning of the harvest season and subsequent years. The combination of statistical techniques presented in this research is an important tool in assessing mycotoxin field test kits fitness for purpose and represents a key step in a continuous improvement-quality systems process meant to protect the feed and food supply.

Determination of tetracycline residues in potatoes and soil by LC-MS/MS: Method development, validation, and risk assessment.

A method utilizing liquid-liquid extraction (LLE) coupled with liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated according to the Commission Implementing Regulation (CIR) EU 2021/808 for quantifying four tetracyclines (TCs) in potatoes and soil. The method demonstrated recovery values ranging from 70 to 121% and precision (repeatability and within-laboratory reproducibility), with coefficient of variation (CV) values below 18% for all TCs in both matrices. The limits of quantification (LOQs) for the TCs ranged from 0.90 to 1.87 µg/kg in potatoes and from 0.68 to 1.25 µg/kg in soil. The decision limit (CCα) and detection capability (CCß) ranged from 10.4 to 12.3 µg/kg and 11.9 to 14.3 µg/kg, respectively. Analysis of 538 potato and soil samples from Egyptian farms revealed a 13.2% occurrence of TC residues, with a higher frequency in soil (19.33%) than in potatoes (7.06%). Target hazard quotient (THQ) values indicated that TC residues in potatoes do not pose a health risk to Egyptian consumers.

Hydrocarbon composition of oils spilt on the Brazilian coast in 2019 and 2022.

The chemical composition of spilt oils from events that took place on the north-eastern coast of Brazil in 2019 and 2022 was investigated to better understand their sources, and post-spill processes. Oils from both events originated from different sources, based on their fingerprints, hydrocarbons composition and specific biomarkers, such as the C23 tricyclic terpane and oleanane. Despite the differences, the source rocks share similarities in paleoenvironments and depositional conditions and both oils suffered little weathering, mainly due to evaporation and dissolution. Our findings for 2019 spilt oil reinforce that it is a mixed product, enriched both in lighter n-alkanes and 25-norhopanes. Differently, the 2022 samples exhibited characteristics of a non-processed crude oil that originated from a paraffinic deposit in storage tanks. The molecular composition and diagnostic ratios reported for samples from these spill events help to establish baselines for ongoing monitoring of oil spills in marine ecosystems.

Validation of classification system for isolated superior mesenteric artery dissections using image-based computational flow analysis.

BACKGROUND AND OBJECTIVE: The isolated superior mesenteric artery dissection (ISMAD) is a rare but potentially fatal vascular disorder. Classifications for ISMAD were previously proposed based on morphometric features. However, the classification systems were not standardized and verified yet. This study conducted computational flow analysis to validate the latest classification system of ISMAD and aid clinical decision-making based on hemodynamic parameters. METHODS: 62 patients with ISMAD were included and classified into different types according to false lumen structures (five types, Type I-V) and true lumen patency (two types, Type P and Type S) according to Qiu classification system. Computational fluid dynamics and three-dimensional structural analyses were conducted on the basis of computed tomography angiography datasets. Quantitative and qualitative functional analyses were performed via parameters of interest including volume flow of each minute, pressure drop, pressure gradient, the derivative parameters of wall shear stress such as time-averaged wall shear stress (TAWSS), oscillatory shear index (OSI), and the relative residence time (RRT). Statistical analyses were conducted among different ISMAD types. RESULTS: TAWSS, OSI and RRT showed significant difference among different types when classified using false lumen structures. In detail, Type IV showed significantly higher TAWSS than other types (p = 0.007). OSI was obviously higher in Type II (p = 0.015). Type IV also presented the lowest RRT (p = 0.005). The pressure drop, pressure gradient, OSI and RRT showed higher value in Type S than that in Type P, demonstrating a statistical significance with p values of 0.017, 0.041, 0.001 and 0.012, respectively. While Type P had larger volume flow than Type S (p = 0.041). CONCLUSIONS: The notable differences in hemodynamic features among different types demonstrated the feasibility of Qiu classification system. The evaluation based on hemodynamic simulation might also provide insights into risk identification and guide therapeutic decisions for ISMAD.

Quantitative determination of liposomal irinotecan and SN-38 concentrations in plasma samples from children with solid tumors: Use of a cryoprotectant solution to enhance liposome stability.

Preclinical studies have demonstrated that liposomal irinotecan (CPT-11), a topoisomerase I inhibitor, has broad activity against adult cancers, including pancreatic, gastric, colon, lung, glioma, ovarian, and breast cancer. Encapsulation of irinotecan into liposomes can modify its pharmacokinetic properties dramatically. Also, the pharmacokinetic profiles of liposomal drug formulations are not fully understood; thus, bioanalytical methods are needed to separate and quantify nonencapsulated vs. encapsulated concentrations. In this study, two robust, specific, and sensitive LC-MS/MS methods were developed and validated to separate and quantify the nonencapsulated CPT-11 (NE-CPT-11) from the sum-total CPT-11 (T-CPT-11) and its major metabolite, SN-38, in human plasma after intravenous administration of liposomal irinotecan. NE-CPT-11 and SN-38 were separated from plasma samples by using solid-phase extraction, and T-CPT-11 was measured by protein precipitation. The liposomal CPT-11 formulation was unstable during sample storage and handling, resulting in elevated NE-CPT-11 concentration. To improve the stability of liposomal CPT-11, a cryoprotectant solution was added to human plasma samples prior to storage and processing. CPT-11, SN-38, and their respective internal standards, CPT-11-d10 and SN-38-d3, were chromatographically separated on a reversed-phase C18 analytical column. The drugs were detected on a triple quadrupole mass spectrometer in the positive MRM ion mode by monitoring the transitions 587.3 > 124.1 (CPT-11) and 393.0 > 349.1 (SN-38). The calibration curves demonstrated a good fit across the concentration ranges of 10-5000 ng/mL for T-CPT-11, 2.5-250 ng/mL for NE-CPT-11, and 1-500 ng/mL for SN-38. The accuracy and precision were within the acceptable limits, matrix effects were nonsignificant, recoveries were consistent and reproducible, and the analytes were stable under all tested storage conditions. Finally, the LC-MS/MS methods were successfully applied in a phase I clinical pharmacokinetic study of nanoliposomal irinotecan (Onivyde®) in pediatric patients with recurrent solid malignancies or Ewing sarcoma.

Calibration of 24-Hour Urinary Sodium Excretion Estimates from Fasting Morning Urine in Chinese Populations: A Comparative Analysis of Two Calibration Models and A Locally Developed Model.

BACKGROUND: Spot urine collection offers a convenient alternative to the more cumbersome 24-hour urine collection. However, the widely recognized estimation models, such as Tanaka and INTERSALT, have not been adequately adapted for widespread use in the general Chinese population. OBJECTIVE: This study was designed to evaluate the precision of the Tanaka and INTERSALT calibration models, alongside a locally-Zhejiang Province formulated model, in predicting 24-hour urinary sodium (24-hUNa) excretion among the Chinese population. METHODS: The study comprised 1,424 participants, aged 18 to 69 years, who provided both comprehensive 24-hour urine and fasting morning urine samples. The researchers assessed the accuracy of the measured 24-hUNa against the estimates obtained from the Tanaka, INTERSALT, and Zhejiang models. This evaluation was conducted at both population and individual levels, employing a range of statistical techniques, including bias analysis, correlation coefficients, intraclass correlation coefficients (ICC), receiver operating characteristic (ROC) curves, Bland-Altman plots, as well as relative and absolute difference calculations, and misclassification rates. RESULTS: The measured average 24-hUNa excretion was found to be 165.7 ± 71.5 mmol/24-hour. Notably, there was a significant deviation between the estimated and measured values for the Tanaka-adjusted model (-11.7 mmol, 95% Confidence Interval (CI): -16.7, -6.7 mmol/24-hour), indicating a statistically significant difference. In contrast, the deviations for the INTERSALT-adjusted model (0.6 mmol, 95% CI: -4.2, 5.4 mmol/24-hour) and the Zhejiang model (0.2 mmol, 95% CI: -4.6, 5.0 mmol/24-hour) were not significant. The correlation coefficients for the models were 0.303, 0.398, and 0.391, respectively, with the INTERSALT-adjusted and Zhejiang models showing superior performance at the population level. CONCLUSIONS: The three evaluation models may serve as effective, low-burden alternatives for assessing urinary sodium levels in the population. However, to enhance the accuracy and reliability of predictions at the individual level, further repeated measurements are necessary to minimize measurement errors and augment the validity of the estimations.

Evaluation of two real-time PCR methods to detect Yersinia enterocolitica in bivalve molluscs collected in Campania region.

Yersinia enterocolitica (Ye) is a foodborne pathogen isolated from humans, food, animals, and the environment. Yersiniosis is the third most frequently reported foodborne zoonosis in the European Union. Ye species are divided into six biotypes 1A, 1B, 2, 3, 4, and 5, based on biochemical reactions and about 70 serotypes. Biotype 1A is non-pathogenic, 1B is highly pathogenic, and biotypes 2-5 have moderate or low pathogenicity. The reference analysis method for detecting pathogenic Ye species underestimates the presence of the pathogen due to similarities between Yersinia enterocolitica-like species and other Yersiniaceae and/or Enterobacteriaceae, low concentrations of distribution pathogenic strains and the heterogeneity of Yersinia enterocolitica species. In this study, the real-time PCR method ISO/TS 18867 to identify pathogenic biovars of Ye in bivalve molluscs was validated. The sensitivity, specificity and accuracy of the molecular method were evaluated using molluscs experimentally contaminated. The results fully agree with those obtained with the ISO 10273 method. Finally, we evaluated the presence of Ye in seventy commercial samples of bivalve molluscs collected in the Gulf of Naples using ISO/TS 18867. Only one sample tested resulted positive for the ail gene, which is considered the target gene for detection of pathogenic Ye according to ISO/TS 18867. Additionally, the presence of the ystB gene, used as target for Ye biotype 1A, was assessed in all samples using a real-time PCR SYBR Green platform. The results showed amplification ystB gene aim two samples.

The diagnostic accuracy of the Arabic version of the Pediatric Sleep Questionnaire for screening for pediatric sleep-related breathing disorders in Saudi children.

BACKGROUND: Pediatric Sleep Questionnaire (PSQ) is a valid, reliable tool for screening for sleep-related breathing disorders (SRBDs) translated into several languages since 2000. The diagnostic accuracy of an Arabic version of the PSQ has never been tested. Our aim was to translate the original version of PSQ into Arabic (Arabic-PSQ), validate it as a reliable screening tool, and compare it to the gold standard diagnostic method for SRBDs. MATERIALS AND METHODS: This was a prospective longitudinal study of 54 children (2-14 years) who were to undergo polysomnography (PSG). SRBD was assessed by administering the Arabic version of PSQ to the parents of these children. The validity and reliability of the Arabic-PSQ were assessed. Data were analyzed using Stata 16. Correlation between with polysomnographic indices and PSQ scores, as well as measurement of the diagnostic accuracy were determined. Receiver operating characteristic analysis between the mean PSQ scores and binary PSG results was done and the area under curve (AUC) value was calculated. RESULTS: Thirty-four (63%) children were diagnosed with obstructive sleep apnea by PSG (Apnea-Hypopnea Index [AHI] ≥1), 26 of whom were accurately identified with the Arabic-PSQ (76.5%). Arabic-PSQ showed comparable validity and reliability. Using a cutoff of 0.33, the score showed a significant correlation with AHI: Rs: 0.30 (P = 0.029). The sensitivity was 76.5%, the specificity was 50%, the positive predictive was 72.2%, the negative predictive value was 55.6%, the positive likelihood ratio was 1.63, and the negative likelihood ratio was 0.37. CONCLUSIONS: The Arabic-PSQ is a valid tool for the screening of Arabic-speaking populations for SRBD. It is valuable for directing the diagnostic approach in a timely and cost-effective manner.

Development and validation of dependence and craving measures specific to athletes who use anabolic-androgenic steroids.

Background: Anabolic-androgenic steroid (AAS) dependence affects approximately 30% of people who use AAS. Presently, measures to assess and diagnose AAS dependence are adapted from scales specific to other forms of drug misuse (e.g., alcohol), containing issues with internal consistency and breadth of construct capture. Additionally, there are no measures available to assess AAS craving, which represents a potentially important coeval factor to AAS dependence. Therefore, this study aimed to develop and provide evidence of validity for measures of AAS dependence and AAS craving. Methods: Data were collected from male and female strength athletes who use AAS across two samples (n sample 1 = 206; n sample 2 = 224). Sample 1 completed the new measures alongside instruments assessing theoretically related constructs (Doping Moral Disengagement, Doping Self-Regulatory Efficacy Scale, craving items from the Wisconsin Smoking Withdrawal Scale, AAS adapted Diagnostic and Statistical Manual for Mental Disorder 4th Edition), whereas Sample 2 completed the new instruments. Results: Exploratory and Confirmatory Factor Analyses (CFA) with Sample 1 data were used to finalize the item sets for both measures and determine the factorial structures of the AAS Dependence Scale (AASDS) and AAS Craving Scale (AASCS). The AASDS consists of 15-items across five first-order factors that are represented by one second-order factor. The AASCS consists of 16-items across four first-order factors that are represented by one second-order factor. Evidence supporting the concurrent, convergent and discriminant validity of scores obtained with both scales was provided through their associations with the theoretically related variables. CFA with the data from Sample 2 confirmed the factor structures for both scales. Conclusion: The AASDS and AASCS represent valid and reliable measures of AAS dependence and AAS craving for use in research with strength athletes who use AAS.