Reliable Screening Tool Research Articles

Fluorescence immunosensor based on a specific monoclonal antibody for highly sensitive and rapid detection of gizzerosine in feed

Gizzerosine is a biogenic amine produced in fish meal drying process and posted higher mortality due to gizzard erosion in poultry than histamine. However, it is difficult to obtain gizzerosine and achieve sensitive practical detection due to its simple structure. Herein, a monoclonal antibody (mAb) specific to gizzerosine was generated based on the new structural design and a fluorescence immunosensor for sensitive and on-site detection of gizzerosine in feed was first established. Molecular modeling of the three-dimensional (3D) structure and surface electrostatic potential of gizzerosine indicated that the carbonyl group of gizzerosine hapten might affect the important sites of antigen-antibody interactions. The proposed structure was used to obtain the sensitive and specific mAb with IC50 of 3.88 ng/mL in indirect competitive ELISA which was approximately 100-fold lower than that of direct competitive ELISA. Considering the practical application scenarios, a fluorescence immunosensor based on microporous dry method integrated with independent quality control line was established to improve detection stability. Under the optimum conditions, the proposed immunosensor showed a good linear relationship from 1.10 to 19.78 ng/mL and provided a low detection limit of 50 ng/g which was approximately 80-fold lower than the maximum recommended amount (0.4 mg/kg) of gizzerosine in feed. The recoveries of 6 kinds of feed ranged from 83.1 % to 114.3 %, which was in good consistence with that of UHPLC–MS/MS. Overall, this work provides a fast, cost-effective and reliable on-site tool for rapid screening of gizzerosine residues in feed samples.

Association of distal radial fracture with comorbidities: model development and validation

BackgroundTo better assess the risk of distal radial fracture in the general population, we need models that take into account a wide range of risk factors other than osteoporosis. The objective was to develop and validate a model for association of patients’ characteristics with distal radial fracture that effectively incorporates multifactorial aspects and includes comorbidities. MethodWe analyzed data from a large Longitudinal Health Insurance Database between 2000 and 2013. The outcome of the study was the occurrence of distal radial fracture and the predictors were demographic and comorbidity data. Two machine learning models were developed and validated for patients ≥50 (N = 2745) and <50 (N = 1587) years of age. ResultsFor patients aged ≥50 years, selected characteristics included sex, age, urbanization level, osteoarthritis, carpal tunnel syndrome, obesity, hyperlipidemia, trigger finger, hypertension, hypothyroidism, diabetes, hyperthyroidism, and rheumatoid arthritis. For patients <50 years old, selected characteristics included age, sex, diabetes mellitus, urbanization level, carpal tunnel syndrome, hyperlipidemia, osteoarthritis, obesity, and hypertension. Accuracy, sensitivity, specificity, area under the curve, and likelihood ratio were 0.77, 0.83, 0.72, 0.77, and 2.92 for age ≥50 years and 0.73, 0.79, 0.67, 0.73, and 2.41 for age <50 years. ConclusionThe study models can serve as reliable screening tools to assess the risk of distal radial fracture in the general population before bone mineral density testing. In addition, they can be integrated into decision support systems to help healthcare providers identify high-risk patients for additional evaluation and education, ultimately improving the quality of care.

Ophthalmic Artery Doppler as a Reliable Tool for Screening and Diagnosing Preeclampsia in a Rural South Indian Population

Ophthalmic Artery Doppler as a Reliable Tool for Screening and Diagnosing Preeclampsia in a Rural South Indian Population

IN VITRO PERMEABILITY STUDY OF NASAL MEDICINAL PRODUCT FOR SYSTEMIC ACTION

For systemic medicinal products bioavailability is a fundamental characteristic that determines their efficacy and onset of action. Biopharmaceutical parameters of nasal preparations (physicochemical properties of the active substance such as membrane permeability, solubility, lipophilicity, pKa, polymorphic state, type of finished dosage form, pH, osmolarity, composition and characteristics of excipients), affecting bioavailability, are variable and controllable within pharmaceutical development. Besides the use of components that affect enzymatic activity, mucoadhesion and effective con-tact time, mucociliary clearance and viscosity of mucous secretion, changing the rate and degree of absorption of the active substance is possible by modulation of tight junctions and paracellular transport. These processes can be particularly determined by the osmolarity of the dosage form and the use of permeation enhancers. Taking into account the portfolio of excipients available to scientists used in a wide range of concentrations, and, in addi-tion, the requirements of the target product profile in terms of safety and pharmacokinetic parameters, as well as regulatory recommendations for jus-tification of the composition within pharmaceutical development, with particular emphasis on the selection of functional components and the concen-trations used, it is important to have relevant and reliable screening tools when formulating a drug product. Due to the absence of standard bioavailabil-ity assessment methods for nasal preparations, literature review was conducted and methodology of in vitro permeability study for of nasal medicinal products for systemic action with the use of artificial membranes as well as cell line RPMI 2650 of human nasal epithelium is developed. The use of such sufficiently homogeneous barrier films allows to minimize the variability of test conditions. Permeation study of developed compositions of an-timigraine medicinal product is conducted. The results obtained provide evidence of their qualitative compliance and allow to recommend laboratory permeability study on cellulose membranes for the selection and justification of the composition of pharmaceutical compositions. Bioavailability is a fundamental characteristic of pharmaceutical products for systemic action, which defines efficacy and speed of action. Permeability through biological membranes is defined not only by the properties of active component but also by the particulars of formulation. Due to the absence of standard bioavailability assessment methods for nasal preparations, literature review was conducted and methodology of in vitro permeability study for of nasal medicinal products for systemic action with the use of artificial membranes as well as cell line RPMI 2650 is developed. Permeation study of developed compositions of antimigraine medicinal product is conducted. The results obtained provide evidence of their qualitative compliance and allow to recommend laboratory permeability study on cellulose membranes as a screening tool in pharmaceutical development.

AUTOMATED ATRIAL FIBRILLATION DETECTION DURING ROUTINE BLOOD PRESSURE MEASUREMENT: DIAGNOSTIC ACCURACY OF THE OSCILLOMETRIC BLOOD PRESSURE MONITOR MICROLIFE BP B3 AFIB ADVANCED

Objective: To evaluate the diagnostic accuracy of the oscillometric upper-arm cuff home blood pressure (BP) monitor Microlife BP B3 AFIB Advanced in detecting atrial fibrillation (AF) during automated BP measurement. Design and method: Participants with permanent AF aged &gt;60 years (AF group) and others with sinus rhythm (SR) matched for age and sex (control group) were recruited. Electrocardiography (ECG) recording and blood pressure (BP) measurements were simultaneously conducted twice for each participant. Using an AF specific diagnostic algorithm of the BP monitor, the rhythmicity of heart rate was evaluated three times during each automated BP measurement. When AF is detected in at least 2 of the 3 assessments, the device reports the presence of AF detection. A single wide-range cuff of the test device was used for arm circumference 22-42 cm. Results: A total of 108 individuals were analyzed, (50%/50% with AF/SR, 59%/59% men, mean age [SD] 76±10.5/73±9.5 years for AF/SR, systolic BP 123.4±19.6/131.5±17.9 mmHg [p&lt;0.01], diastolic BP 74.2±11.7/73.4±10.6 mmHg [p=NS]). False negative and false positive AF detection in AF and control group respectively are shown in Table. The sensitivity of the test device in detecting AF was 87%, specificity 100%, positive predictive value 100% and negative predictive value 88.5%. Conclusions: These findings indicate that the Microlife BP B3 AFIB Advanced automated BP monitor equipped with an AF detecting algorithm with triplicate assessment of the cardiac rhythm during each automated BP measurement, has an exceptional diagnostic accuracy. Thus, this novel technology can be employed as a reliable screening tool for detecting asymptomatic AF in elderly adults during routine screening or long-term monitoring of treated hypertension.

Cross-cultural adaptation of the PHQ-4 to European Portuguese and its validation with the psychological burden by the multimorbidity management in GP/FM practice in Central Portugal

Background: Mental health is an important issue in general practice/family medicine. The Patient Health Questionnaire for Depression and Anxiety (PHQ-4) allows depression and anxiety screening and psychologic distress evaluation. PHQ-4 cross-cultural adaptation and concurrent validation was the objective of this paper in a population of general practice/family medicine (GP/FM) doctors. Methods: Translation, linguistic verification and back-translation, internal consistency, and reliability of the final translated tool were performed for the cultural adaptation of the PHQ-4 scale. The European Quality of Life 5 Dimensions 3L (EQ-5D-3L) scale and the “Sentimentos Negativos – Negative Feelings”, subscale of the “Questionário da Avaliação da Sobrecarga da Gestão da Multimorbilidade em Medicina Geral e Familiar – Questionnaire of Evaluation of Burden of Management of Multimorbidity in General Practice and Family Medicine” [SoGeMM-MGF]) were used for concurrent validation. Descriptive, inferential, and correlational statistics were used, according to the distribution of data, with a p-value of &lt;0.01 for statistical significance being defined. Conclusion: PHQ-4 scale cultural adaptation and concurrent validity were made, PHQ4 being a valid and reliable screening tool, to assess anxiety, depression, and psychological distress.

Development and validation of an early diagnosis model for bone metastasis in non-small cell lung cancer based on serological characteristics of the bone metastasis mechanism

Bone metastasis significantly impact the prognosis of non-small cell lung cancer (NSCLC) patients, reducing their quality of life and shortening their survival. Currently, there are no effective tools for the diagnosis and risk assessment of early bone metastasis in NSCLC patients. This study employed machine learning to analyze serum indicators that are closely associated with bone metastasis, aiming to construct a model for the timely detection and prognostic evaluation of bone metastasis in NSCLC patients. The derivation cohort consisted of 664 individuals with stage IV NSCLC, diagnosed between 2015 and 2018. The variables considered in this study included age, sex, and 18 specific serum indicators that have been linked to the occurrence of bone metastasis in NSCLC. Variable selection used multivariate logistic regression analysis and Lasso regression analysis. Six machine learning methods were utilized to develop a bone metastasis diagnostic model, assessed with Area Under the Curve (AUC), Decision Curve Analysis (DCA), sensitivity, specificity, and validation cohorts. External validation used 113 NSCLC patients from the Medical Alliance (2019-2020). Furthermore, a prospective validation study was conducted on a cohort of 316 patients (2019-2020) who were devoid of bone metastasis, and followed-up for at least two years to assess the predictive capabilities of this model. The model's prognostic value was evaluated using Kaplan-Meier survival curves. Through variable selection, 11 serum indictors were identified as independent predictive factors for NSCLC bone metastasis. Six machine learning models were developed using age, sex, and these serum indicators. A random forest (RF) model demonstrated strong performance during the training and internal validation cohorts, achieving an AUC of 0.98 (95% CI 0.95-0.99) for internal validation. External validation further confirmed the RF model's effectiveness, yielding an AUC of 0.97 (95% CI 0.94-0.99). The calibration curves demonstrated a high level of concordance between the anticipated risk and the observed risk of the RF model. Prospective validation revealed that the RF model could predict the occurrence of bone metastasis approximately 10.27±3.58 months in advance, according to the results of the SPECT. An online computing platform (https://bonemetastasis.shinyapps.io/shiny_cls_1model/) for this RF model is publicly available and free-to-use by doctors and patients. This study innovatively employs age, gender, and 11 serological markers closely related to the mechanism of bone metastasis to construct an RF model, providing a reliable tool for the early screening and prognostic assessment of bone metastasis in NSCLC patients. However, as an exploratory study, the findings require further validation through large-scale, multicenter prospective studies. This work is supported by the National Natural Science Foundation of China (NO.81974315); Shanghai Municipal Science and Technology Commission Medical Innovation Research Project (NO.20Y11903300); Shanghai Municipal Health Commission Health Industry Clinical Research Youth Program (NO.20204Y034).

Miniaturization of hiPSC-derived 3D neural cultures in stirred-tank bioreactors for parallelized preclinical assessment of rAAV.

Introduction: Engineered 3D models employing human induced pluripotent stem cell (hiPSC) derivatives have the potential to recapitulate the cell diversity and structure found in the human central nervous system (CNS). Therefore, these complex cellular systems offer promising human models to address the safety and potency of advanced therapy medicinal products (ATMPs), such as gene therapies. Specifically, recombinant adeno-associated viruses (rAAVs) are currently considered highly attractive for CNS gene therapy due to their broad tropism, low toxicity, and moderate immunogenicity. To accelerate the clinical translation of rAAVs, in-depth preclinical evaluation of efficacy and safety in a human setting is primordial. The integration of hiPSC-derived CNS models in rAAV development will require, amongst other factors, robust, small-scale, high-throughput culture platforms that can feed the preclinical trials. Methods: Herein, we pioneer the miniaturization and parallelization of a 200mL stirred-tank bioreactor-based 3D brain cell culture derived from hiPSCs. We demonstrate the applicability of the automated miniaturized Ambr® 15 Cell Culture system for the maintenance of hiPSC-derived neurospheroids (iNSpheroids), composed of neuronal and glial cells. Critical process parameters were optimized, namely, cell density and agitation mode. Results: Under optimized conditions, stable iNSpheroid cultures were attained in the microbioreactors for at least 15days, with high cell viability and astrocytic and neuronal phenotype maintenance. This culture setup allowed the parallelization of different rAAVs, in different multiplicity of infections (MOIs), to address rAAV-host interactions at a preclinical scale. The iNSpheroids were exposed to rAAV2- and rAAV9-eGFP in the microbioreactors. Transgene expression was detected 14days post-transduction, revealing different astrocyte/neuron tropism of the two serotypes. Discussion: We advocate that the iNSpheroid cultures in miniaturized bioreactors are reliable and reproducible screening tools for addressing rAAV transduction and tropism, compatible with preclinical demands.

Validity of Hematological scoring system in diagnosis of neonatal sepsis at Birat Medical College Teaching Hospital

Introduction: Newborns are vulnerable to infections. Timely diagnosis of neonatal sepsis can avoid major morbidity and mortality. Neonates with sepsis present with non-specific signs and symptoms. Timely diagnosis is important. Though blood culture is gold standard, it consumes time. Hematological scoring system (HSS) using hematological parameters can be effective in early diagnosis of sepsis. Objectives: To evaluate the effectiveness (Sensitivity, specificity, Positive Predictive value (PPV), Negative Predictive value (NPV) of HSS and their individual parameters in diagnosis of neonatal sepsis. Methodology: This was the cross-sectional study done at tertiary care hospital for period of six months. Neonates with clinical suspicion of sepsis were included in the study. Blood was drawn from neonate in two vials, one was sent for culture and other for calculation of hematological parameters as per Rodwell Hematological scoring system. Diagnostic study parameters were calculated. Result: Total of 143 neonates clinically suspected of sepsis were included in the study with 83 having positive blood culture. Highest sensitivity (86.7%) was recorded for Total Polymorph neutrophil (PMN) while highest specificity (93.3) and PPV (81.8) for I: T PMN ratio. A sensitivity of 67.5% and specificity of 91.7% was seen along with PPV of 91.8% and NPV of 67.1% with HSS greater than or equal to 5. Conclusion: HSS of greater than or equal to 5 can be considered to be the reliable screening tool for diagnosis of sepsis.

Design and validation of a diagnostic suspicion checklist to differentiate epileptic from psychogenic nonepileptic seizures (PNES-DSC)

ObjectivePsychogenic non-epileptic seizures (PNES) are complex clinical manifestations and misdiagnosis as status epilepticus remains high, entailing deleterious consequences for patients. Video-electroencephalography (vEEG) remains the gold-standard method for diagnosing PNES. However, time and economic constraints limit access to vEEG, and clinicians lack fast and reliable screening tools to assist in the differential diagnosis with epileptic seizures (ES). This study aimed to design and validate the PNES-DSC, a clinically based PNES diagnostic suspicion checklist with adequate sensitivity (Se) and specificity (Sp) to discriminate PNES from ES. MethodsA cross-sectional study with 125 patients (n = 104 drug-resistant epilepsy; n = 21 PNES) admitted for a vEEG protocolised study of seizures. A preliminary PNES-DSC (16-item) was designed and used by expert raters blinded to the definitive diagnosis to evaluate the seizure video recordings for each patient. Cohen's kappa coefficient, leave-one-out cross-validation (LOOCV) and balance accuracy (BAC) comprised the main validation analysis. ResultsThe final PNES-DSC is a 6-item checklist that requires only two to be present to confirm the suspicion of PNES. The LOOCV showed 71.4% BAC (Se = 45.2%; Sp = 97.6%) when the expert rater watched one seizure video recording and 83.4% BAC (Se = 69.6%; Sp = 97.2%) when the expert rater watched two seizure video recordings. ConclusionThe PNES-DSC is a straightforward checklist with adequate psychometric properties. With an integrative approach and appropriate patient history, the PNES-DSC can assist clinicians in expediting the final diagnosis of PNES when vEEG is limited. The PNES-DSC can also be used in the absence of patients, allowing clinicians to assess seizure recordings from smartphones.

Distortion-Product Otoacoustic Emission of Cochlear Hair Cells in Pediatric Patients Presenting with Various Perinatal Morbidities

Background: Hearing plays a substantial role in the growth of intellect- as well as language-related abilities in children. Congenital hearing loss leads to deficiency and defects in the growth of various abilities such as speech leading to emotional distress. The aim of our study was to detect cochlear hair cell damage in various perinatal morbidities as measured from distortion-product otoacoustic emission (DPOAE) in the pediatric age group. Materials and Methods: A 1-year prospective observational study was conducted on 65 children comprising 28 pediatric and 37 neonatal patients attending a tertiary care hospital. Results: Among 65 children, 25% of patients having perinatal risk factors failed the OAE test. The majority of neonates passed the OAE test (97.3%) as compared to the pediatric age group (60.7%). The most common risk factor associated with OAE “fail” was neonatal jaundice (100%), followed by low birth weight (35%) and respiratory distress (36%). We found no relation of “fail” OAE test with the Apgar scale (4–6). The mean signal–noise ratio (SNR) variable was highest in the frequency range of 4 and 6 kHz in neonates with statistically significant values for the frequency band of 2, 4, and 6 kHz. The above findings confirmed that the OAE recordings observed in the group of children were reliable. Conclusion: The SNR variable of DPOAE is an effective and reliable screening tool at particular frequencies. Emphasis on hearing screening using OAE should be prioritized in cases of neonatal jaundice and respiratory distress and also for patients in the age group from &gt;1 month to 12 years.

Utility of the Paris System in Urine Cytology for Improved Screening of High-Grade Urothelial Carcinoma in Bahrain.

Urothelial carcinoma, a prevalent and aggressive urological malignancy, necessitates early detection for improved prognosis. Urine cytology serves as a cost-effective screening tool, but inconsistencies in reporting due to the lack of standardized criteria limit its efficacy. The Paris System for reporting urinary cytology (TPS) was introduced to address this issue, aiming to improve diagnostic accuracy. This retrospective study investigates the effectiveness of urine cytology in detecting high-grade urothelial carcinoma (HGUC) using TPS classification, specifically focusing on atypical urothelial cells (AUC) categorized as TPS-III and suspicious for high-grade urothelial carcinoma (SHGUC) categorized as TPS-IV. We reviewed 470 urine cytology samples collected over two years at a tertiary healthcare center in Bahrain. All samples were re-evaluated using TPS classification by two independent consultant cytopathologists blinded to the original cytology report. The analysis included only samples categorized as TPS-III or TPS-IV with corresponding histopathology reports from confirmatory biopsies performed within four months of urine collection. Biopsy results were categorized as either benign/low-grade urothelial carcinoma (non-HGUC) or malignant (HGUC). The positive predictive value (PPV) of urine cytology for HGUC detection was calculated for both TPS-III and TPS-IV categories. Statistical significance was assessed using Fisher's exact test. Among the 470 urine cytology samples, 40 (8.5%) were classified as TPS-III or TPS-IV. Within this subset, 16 patients underwent confirmatory biopsies. Histopathological analysis revealed HGUC in 12 (75%) patients and non-HGUC (benign or low-grade) in 4 (25%) patients. The PPV of TPS-III for HGUC was 50%, while TPS-IV demonstrated a higher PPV of 90%. However, the difference between these values was not statistically significant (p = 0.25).This study explored the utility of TPS classification in urine cytology for HGUC detection. While SHGUC (TPS-IV) exhibited a numerically higher PPV compared to AUC (TPS-III), the lack of statistical significance necessitates further investigation. Our findings highlightthe potential of TPS to improve the accuracy of urine cytology. TPS implementation has been shown to reduce the number of inconclusive "atypical" diagnoses, leading to more targeted investigations. Our study suggests that SHGUC (TPS-IV) within TPS classification framework might hold promise as a more specific indicator for HGUC compared to AUC (TPS-III). However, further research with larger cohorts is necessary to definitively establish the clinical significance of this observation. This investigation paves the way for future studies exploring the potential of TPS, particularly the SHGUC category, as a reliable screening tool for HGUC, potentially leading to earlier diagnoses and improved patient outcomes.

Psychometric Evaluation of the Hungarian Adaptation of the Diabetes Distress Scale in Individuals with Type 2 Diabetes.

Background and Purpose: Diabetes-specific distress (DD) is a crucial predictor of patients' self-care, necessitating reliable screening tools. The Diabetes Distress Scale captures typical sources of patients' distress effectively. Methods: The Hungarian Diabetes Distress Scale (HDDS) was employed in two studies with 450 type 2 diabetes patients. Study 1 explored DD's link to the specific quality of life, while study 2 examined its associations with depressive symptoms, anxiety, and illness perception. We evaluated HDDS's construct validity, internal consistency, and intercorrelations. Convergent validity and discriminant validity were analyzed in the second study. Results: Exploratory and confirmatory factor analyses validated HDDS's structure. Subscales exhibited strong internal consistency and correlated as expected with quality of life, anxiety, depression, illness perception, and demographic/medical data. Conclusions: The Hungarian DDS demonstrates robust psychometric properties, affirming its reliability and validity.

Classification of Childhood Obstructive Sleep Apnea based on X-ray images analysis by Quasi-conformal Geometry

Craniofacial profile is one of the anatomical causes of obstructive sleep apnea (OSA). By medical research, cephalometry provides information on patients’ skeletal structures and soft tissues. In this work, a novel approach to cephalometric analysis using quasi-conformal geometry based local deformation information was proposed for OSA classification. Our study was a retrospective analysis based on 60 case-control pairs with accessible lateral cephalometry and polysomnography (PSG) data (mean age: 8.9 ± 2.3 years). By using the quasi-conformal geometry to study the local deformation around 15 landmark points, and combining the results with three linear distances between landmark points, a total of 1218 information features were obtained per subject. A L2 norm based classification model was built. Under experiments, our proposed model achieves high testing accuracy. The accurate classification tool provides us with a reliable and accurate screening tool for childhood OSA.

Abstract 7391: Beyond traditional staining: A virtual-IHC digital assay for HER2 score prediction from routine H&amp;E images

Abstract Background: In breast cancer diagnostics, the accurate assessment of HER2 status is essential for treatment stratification. Conventionally, HER2 immunohistochemistry (IHC) scoring necessitates specialized staining protocols, which are resource- and time-intensive. This study presents a virtual IHC (vIHC) digital assay to predict HER2 scores directly from hematoxylin and eosin (H&amp;E) stained images, which are routinely acquired for all specimens. This methodology aims to accelerate standard practices by reducing the need for additional IHC staining, thereby decreasing laboratory workload, costs, and turnaround time. It also presents an opportunity to screen a wider array of samples promptly, potentially identifying candidates for HER2-targeted therapy that might otherwise be delayed or overlooked. Methods: Serially sectioned breast core needle biopsy samples were stained with H&amp;E and HER2-IHC following Leica-Bond staining protocols. Stained slides were imaged using the Hologic GeniusTM Digital Diagnostics System with Research Use Only software for Whole Slide Imaging. From this initial image dataset, 240 regions of interest (ROIs) were manually selected in order to create a dataset that uniformly covers: (i) all HER2-IHC scores (0-3), (ii) a wide range of HER2 stain intensities, and (iii) expression patterns. The IHC scores were assigned to each selected ROI by a pathology expert, following the scoring recommendations of ASCO/CAP American Society of Clinical Oncology and College of American Pathologists, with the caveat that ductal carcinoma in situ was also given a score for the purpose of training the model. These ROIs were then extracted from the images of the serially sectioned H&amp;E-stained slides using Reveal Bio’s proprietary co-registration digital assay. A predictive digital assay was developed at Reveal Biosciences to classify the 240 H&amp;E-stained breast tissue ROIs into four HER2 IHC score categories: 0, 1, 2, and 3. For model evaluation, cross-validation was performed 10 times by randomly splitting the dataset of H&amp;E ROIs into 80% for training MIL and 20% for testing the model, followed by averaging the performance metrics across the 10 dataset splits. The performance metrics included classification accuracy, precision, recall, and F1 scores for each HER2 score category. Results: The vIHC digital assay for predicting the HER2 scores directly from H&amp;E stained breast tissue images achieved the average classification accuracy of 93% across the four HER2 score categories on the test set of ROIs. This performance demonstrates that the model is capable of successfully distinguishing between the HER2 score categories directly from H&amp;E images without the need for IHC staining. The results suggest that the vIHC digital assay could be a reliable and cost-effective tool for preliminary breast cancer screening, providing a valuable adjunct to traditional histopathological analysis. Citation Format: Misagh Naderi, Nikola Mitic, Nikola Spasic, Djordje Cikic, Kristen Ruf, Nikolaus Wagner, Igor Mihajlovic, Sinisa Todorovic, Ray Jenoski, Sid Mayer, Michael Quick, Claire Weston. Beyond traditional staining: A virtual-IHC digital assay for HER2 score prediction from routine H&amp;E images [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 7391.

Development of a simple screening method for analyzing cereulide toxin in fried rice using liquid chromatography-tandem mass spectrometry.

The presence of cereulide, an emetic toxin produced by Bacillus cereus, in fried rice samples is critical evidence of food poisoning even in situations where B. cereus could not be detected. This study aims to develop a screening method for analyzing cereulide in fried rice using the QuEChERS procedure and liquid chromatography-tandem mass spectrometry (LC-MS/MS). Cereulide was identified and quantified in fried rice samples using the QuEChERS extraction method and LC-MS/MS. The accuracies of the methods were determined by analyzing fortified blank samples at two concentrations (10 and 50µg/kg) conducted on three samples daily for five days. The QuEChERS procedure removed matrix compounds from fried rice. Characteristic MS/MS spectra enabled the identification of cereulide. As the matrix effects in seven fried rice samples were within ± 6%, an external solvent calibration curve could be used for quantification. This method exhibited good accuracy ranging from 88 to 89%. The relative standard deviations for both repeatability and intra-laboratory reproducibility were < 4%. These standard deviations satisfied the criteria of the Japanese validation guidelines for residues (MHLW 2010, Director Notice, Syoku-An No. 1224-1). The limit of quantification was 2μg/kg. The applicability of this method was confirmed using the analysis of cereulide in fried rice samples incubated with emetic Bacillus cereus. The QuEChERS extraction procedure described herein showed substantial promise as a reliable screening tool for cereulide in fried rice sample.

Validation and cultural adaptation of a Greek Version of Pediatric Eating Assessment Tool 10 (PEDI – EAT – 10) in Greek-Cypriot Parents

Purpose The Pediatric Eating Assessment Tool (PEDI-EAT-10) is a parents/caregivers screening tool that assesses pediatric patients at risk of penetration and/or aspiration symptoms. The aim of this study was the validation of PEDI-EAT-10 in the Greek language. Materials and Methods This cross-sectional study included 222 parents/caregivers of children with (n = 122) and without (n = 100) feeding and/or swallowing disorders, with age range 3 – 12 years. The children were selected from Cypriot schools and health settings. All parents filled out the PEDI-EAΤ-10 questionnaire and after its initial completion, it was re-administered after 2 weeks. Results A statistically significant difference was observed in the PEDI-EAT-10 total mean scores between the study’s two groups [t (220) = 9.886, p < 0.001]. Internal consistency was high (Cronbach’s alpha= 0.801) with very good split-half reliability equal to 0.789. A significant and strong test-retest reliability was computed (r = 0.998, p < 0.001). The PEDI-EAT-10 cutoff point was 11.00 (AUC: 0.869, p < 0.001) for children with feeding and/or swallowing disorders in accordance with the PAS scale. Conclusions In conclusion, the Greek version of PEDI-EAT-10 is shown to be a valid and reliable screening tool for the assessment of the pediatric population with a risk of dysphagia.

Development of Digit in Noise Test in Hindi.

The digit in the noise test is a simple hearing screening tool that can identify hearing loss at the early stage. This screening tool takes less time than traditional pure-tone audiometry. There is a scarcity of hearing health professionals with few resources for carrying out hearing screening on a large scale in India. Hence, a hearing screening tool for the Hindi-speaking population is needed. The study aimed to develop and validate the Digit in Noise test in Hindi (DIN-H). A native Hindi female speaker recorded single digits from 1 to 9 made into triplet combinations, which were binaurally presented to 20 normal hearing subjects having hearing thresholds less than 25 dBHL from 250 to 8000Hz in the presence of broadband speech-shaped noise. The digit triplets were homogenized using speech intelligibility function for similar difficulty levels across stimuli. The homogenized stimuli were evaluated by obtaining the Speech Recognition Threshold (SRT) of 20 normal hearing subjects. The Mean SRT was - 10.4 and - 11.3 dB before and after homogenization. A strong positive correlation existed between test and retest SRTs (0.78). Mean SRT and slope obtained before and after optimization were comparable to other languages like Korean and English. This test can act as a reliable screening tool for assessing individuals. The test was administered to 106 normal hearing participants. The 95th percentile of the SRT value obtained was - 5.6 dB, which was kept as a cut-off score for the screening test. DIN-H can be used as a screening tool for assessing the integrity of the auditory system on a large scale in less time for the Hindi-speaking population.

Validity of nutrition screening tools for risk of malnutrition among hospitalized adult patients: A systematic review and meta-analysis

Backgrounds & AimsMalnutrition is prevalent among hospitalized patients in developed countries, contributing to negative health outcomes and increased healthcare costs. Timely identification and management of malnutrition are crucial. The lack of a universally accepted definition and standardized diagnostic criteria for malnutrition has led to the development of various screening tools, each with varying validity. This complicates early identification of malnutrition, hindering effective intervention strategies. This systematic review and meta-analysis aimed to identify the most valid and reliable nutritional screening tool for assessing the risk of malnutrition in hospitalized adults. MethodsA systematic literature search was conducted to identify validation studies published from inception to November 2023, in the Pubmed/MEDLINE, Embase, and CINAHL databases. This systematic review was registered in INPLASY (INPLASY202090028). The risk of bias and quality of included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies version 2 (QUADAS-2). Meta-analyses were performed for screening tools accuracy using the symmetric hierarchical summary receiver operative characteristics models. ResultsOf the 1,646 articles retrieved, 60 met the inclusion criteria and were included in the systematic review, and 21 were included in the meta-analysis. A total of 51 malnutrition risk screening tools and 9 reference standards were identified. The meta-analyses assessed four common malnutrition risk screening tools against two reference standards (Subjective Global Assessment [SGA] and European Society for Clinical Nutrition and Metabolism [ESPEN] criteria). The Malnutrition Universal Screening Tool (MUST) vs SGA had a sensitivity (95% Confidence Interval) of 0.84 (0.73-0.91), and specificity of 0.85 (0.75-0.91). The MUST vs ESPEN had a sensitivity of 0.97 (0.53-0.99) and specificity of 0.80 (0.50-0.94). The Malnutrition Screening Tool (MST) vs SGA had a sensitivity of 0.81 (0.67-0.90) and specificity of 0.79 (0.72-0.74). The Mini Nutritional Assessment-Short Form (MNA-SF) vs ESPEN had a sensitivity of 0.99 (0.41-0.99) and specificity of 0.60 (0.45-0.73). The Nutrition Universal Screening Tool-2002 (NRS-2002) vs SGA had a sensitivity of 0.76 (0.58-0.87) and specificity of 0.86 (0.76-0.93). ConclusionsThe MUST demonstrated high accuracy in detecting malnutrition risk in hospitalized adults. However, the quality of the studies included varied greatly, possibly introducing bias in the results. Future research should compare tools within a specific patient population using a valid and universal gold standard to ensure improved patient care and outcomes.

Machine learning models for screening clinically significant nephrolithiasis in overweight and obese populations.

Our aim is to build and evaluate models to screen for clinically significant nephrolithiasis in overweight and obesity populations using machine learning (ML) methodologies and simple health checkup clinical and urine parameters easily obtained in clinics. We developed ML models to screen for clinically significant nephrolithiasis (kidney stone > 2mm) in overweight and obese populations (body mass index, BMI ≥ 25kg/m2) using gender, age, BMI, gout, diabetes mellitus, estimated glomerular filtration rate, bacteriuria, urine pH, urine red blood cell counts, and urine specific gravity. The data were collected from hospitals in Kaohsiung, Taiwan between 2012 and 2021. Of the 2928 subjects we enrolled, 1148 (39.21%) had clinically significant nephrolithiasis and 1780 (60.79%) did not. The testing dataset consisted of data collected from 574 subjects, 235 (40.94%) with clinically significant nephrolithiasis and 339 (59.06%) without. One model had a testing area under curve of 0.965 (95% CI, 0.9506-0.9794), a sensitivity of 0.860 (95% CI, 0.8152-0.9040), a specificity of 0.947 (95% CI, 0.9230-0.9708), a positive predictive value of 0.918 (95% CI, 0.8820-0.9544), and negative predictive value of 0.907 (95% CI, 0.8756-0.9371). This ML-based model was found able to effectively distinguish the overweight and obese subjects with clinically significant nephrolithiasis from those without. We believe that such a model can serve as an easily accessible and reliable screening tool for nephrolithiasis in overweight and obesity populations and make possible early intervention such as lifestyle modifications and medication for prevention stone complications.