Current Issue : January-March Volume : 2026 Issue Number : 1 Articles : 5 Articles
Breast milk is the ideal source of nutrition for infant growth and development. However, when nursing mothers consume aflatoxin B1 (AFB1)-contaminated food, the hydroxylated form aflatoxin M1 (AFM1) is transferred to breast milk and urine. AFB1 and its metabolite AFM1 are potent carcinogens and can pose significant risks to food safety and public health worldwide. This study determined the prevalence of AFM1 in the breast milk and urine of nursing mothers in Bangladesh and estimated infant exposure to this toxin. Breast milk and urine samples (72 each), collected from nursing mothers in three different regions of the country, were analyzed for AFM1 occurrence via a sensitive enzyme-linked immunosorbent assay (ELISA). AFM1 was present in 88.9% of urine samples, with a mean concentration of 109.9 ± 52.8 pg/mL, ranging from 40.0 to 223.8 pg/mL. AFM1 was also detected in 50% of the breast milk samples, with a mean concentration of 4.6 ± 0.7 pg/mL, ranging from 4.0 to 6.1 pg/mL. A strong correlation (r = 0.72) was observed between milk and urinary AFM1 levels, indicating these as suitable biomarkers of AFB1 exposure. Yet, no significant correlations were identified between AFM1 levels in either milk or urine and the food items typically consumed by nursing mothers. The average estimated daily intake (EDI) for AFM1 with breast milk was 0.59 ng/kg bw/day, with no significant difference between infants (0.57 ng/kg bw/day) and toddlers (0.65 ng/kg bw/day). A comparison of computed EDI ranges for AFM1 with a proposed tolerable daily intake value resulted in Hazard Indices below 1 for all exposure scenarios. This indicates that the AFM1 concentrations in breast milk from three regions of Bangladesh raise no concern. Also, the measured levels were far lower than the maximal levels set in the EU regulations for AFM1 in dairy milk and infant formula (50 ng/kg and 25 ng/kg, respectively)....
A simple and reliable method was developed using LC-MS/MS to quantify alprazolam, bromazepam, clonazepam, diazepam, and flunitrazepam in clinical samples. This method was validated for the simultaneous determination of alprazolam, bromazepam, clonazepam, diazepam, and flunitrazepam. It was applied to human urine samples collected from people suspected of drug abuse in the Kuwaiti region. Formic acid in water and acetonitrile was used in mobile phase with a gradient mode of elution using C18 reverse-phase column. The instrument was operated in a positive mode with an electrospray ionization source using multiple reaction monitoring. For sample extraction, the liquid-liquid extraction technique was used. The method was validated for limit of detection, limit of quantitation, selectivity, linearity, accuracy, and precision. The concentration for limit of quantitation was 6.0 ng/mL, the linearity ranged from 2.0 to 300 ng/mL for each of the analytes, and the r2 values were ≥0.99. The accuracy was found to be within a range of 80–120% and precision had a %RSD of ≤15% for each of the analytes. The method was applied to 48 urine samples collected from those suspected of drug abuse by the Toxicology Department of the General Department of Criminal Evidence, Kuwait, and alprazolam, bromazepam, clonazepam, diazepam and flunitrazepam were identified commonly in the samples. The overall drug positivity rate obtained considering 48 samples was 93.75%. Based on these results and successful determination of alprazolam, bromazepam, clonazepam, diazepam and flunitrazepam in human urine samples from those suspected of drug abuse, this method is deemed to be suitable for its routine analysis....
Background: Ustekinumab (UST) is a monoclonal antibody (mAb) used in the treatment of inflammatory bowel disease (IBD). Elevated serum concentrations are typically associated with improved therapeutic outcomes, and therapeutic drug monitoring (TDM) is a useful tool for guiding mAbs treatment. This study aimed to develop a dried blood spot (DBS) method for TDM of UST in patients with IBD. Methods: The commercial enzyme-linked immunosorbent assay for plasma samples was optimized for DBS samples and subsequently validated according to international guidelines for classical and DBS-specific validation parameters. It was then applied to analyze serum and DBS samples obtained from venous and capillary blood of IBD patients undergoing UST therapy. Results: The method was linear (3–12 mg/L) with acceptable inter-day accuracy (90.1–106%) and precision (<12%). We confirmed that there was no hematocrit effect and that DBS samples were stable for one month under room conditions. A linear model was developed between venous DBS and serum UST concentrations, which showed no systemic bias, and 71% of the samples were within ±20% of the mean. In addition, a linear correlation between venous DBS and capillary DBS samples was established, showing no significant bias, with 84% of samples within ±20% of the mean. Finally, a novel strategy was developed to overcome the limitations of poor-quality samples (irregular shapes) based on area image analysis. Conclusions: The newly developed DBS method is the first to enable reliable measurement of UST in capillary blood, appropriate clinical interpretation of the measured concentrations, and remote monitoring of patients in the early phase of therapy....
Background/Objectives: A high-performing blood biomarker (BBM) test for Alzheimer’s disease (AD) represents an accurate, accessible, and scalable tool to aid healthcare professionals (HCPs) evaluating patients presenting with signs or symptoms of mild cognitive impairment (MCI) or dementia. However, implementation of AD blood tests into clinical practice has not been extensively evaluated. The objective of this study was to assess the implementation of the multi-analyte PrecivityAD2™ blood test (C2N Diagnostics, LLC, St. Louis, MO, USA) into the clinical workflow of memory care clinics. Methods: A total of 8 HCPs (neurologists, geriatricians, geriatric psychiatrists) who served as site directors from 8 outpatient sites that evaluated 203 cognitively symptomatic patients were included in this sub-study of the real-world QUIP II Study (NCT06025877). Implementation of this blood test was assessed through surveying these HCPs using published frameworks including the Technology Acceptance Model, net promoter score, and forced choice preference questions. These assessments were analyzed using Wilcoxon signed-rank test, Fisher’s Exact test, and Wilcoxon signed-rank test, respectively. Results: HCPs reported acceptance scores that averaged 9.6 out of 10 (p < 0.0001, effect size 0.840): the test’s contribution to clinical decision-making as well as the ease of understanding test results received the highest ratings. The net promoter score was 75 (p < 0.0001), exceeding the typical benchmark of 30 reported as good levels of satisfaction in healthcare settings. The APS2 results and individual blood analyte results were rated with similar preference around their roles in HCP clinical decision-making. Conclusions: The results indicate early evidence of user acceptance and recognition by HCPs that this AD blood test can personalize the clinical care pathway for evaluating cognitively symptomatic patients....
Background/Objectives: The rapid identification of carbapenemase genes directly from positive blood culture (BC) samples shortens the time needed to initiate optimal antimicrobial therapy for Carbapenemase-Producing Enterobacterales (CPE) infections. Several commercial automated PCR systems are available for detecting CPE resistance genes but are expensive. The Xpert® Carba-R assay (Cepheid GeneXpert System) has high sensitivity and specificity for the detection of carbapenamase genes from bacterial colonies or rectal swabs, with an affordable price. This assay was not used for positive BC testing of CPE resistance genes. Whole-Genome Sequencing (WGS) for resistance genes can be used as the gold standard at a research level. In this study, we evaluated the performance of the Xpert® Carba-R assay for the early detection of carbapenamase genes directly from positive BCs, using WGS as the gold standard. Methods: A prospective observational study was conducted at Children’s Cancer Hospital-Egypt (CCHE-57357). All positive BCs underwent direct gram staining and conventional cultures. A total of 590 positive BCs containing Gram-negative rods (GNRs) were identified. The Xpert® Carba-R assay was used to detect carbapenemase genes directly from the positive BC bottle compared with WGS results. Results: Among the 590 GNR specimens, 178 were found to carry carbapenemase genes using the Xpert® Carba-R assay, with results obtained in approximately one hour. The main genotypes detected were blaNDM, blaOXA-48-like, and dual blaNDM/blaOXA-48-like at 27%, 29%, and 33%, respectively. The agreement between Xpert® Carba-R assay and WGS results was almost perfect for the genotype resistance pattern of isolates and individual gene detection. Conclusions: The use of the Xpert® Carba-R assay directly from BC bottles was an easy-to-use, time-saving, affordable tool with high accuracy in identifying carbapenemase genes and, thus, shortens the time needed to initiate optimal antimicrobial therapy for CPE infections....
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