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Use of Remote Regulatory Assessment (RRA) for Site Evaluations during the COVID-19 Pandemic: The USFDA's Office of Study Integrity and Surveillance (OSIS) Perspective.
AAPS PharmSciTech
January 2025
OSIS, Silver Spring, Maryland, U.S.A.
Travel restrictions during the novel coronavirus, SARS-CoV-2 (COVID-19) public health emergency affected the U.S. Food and Drug Administration's (FDA) ability to conduct on-site bioavailability/bioequivalence (BA/BE) and Good Laboratory Practice (GLP) nonclinical inspections.
View Article and Find Full Text PDFNanoparticle-mediated light-driven LAMP combined with test strips for sensitive and rapid visual detection of antibiotic resistance genes.
J Hazard Mater
December 2024
State Key Laboratory of Food Science and Resources, Jiangnan University, Wuxi 214122, China; International Joint Laboratory on Food Safety, Institute of Analytical Food Safety, School of Food Science and Technology, Jiangnan University, Wuxi, Jiangsu 214122, China. Electronic address:
Antibiotic resistance genes (ARGs) are markers of drug-resistant pathogens, monitoring them contributes to prevent resistance to drugs. The detection methods for ARGs including PCR and isothermal amplification are sensitive and selective. However, it may take several hours or cannot be used on spot.
View Article and Find Full Text PDFMicropore Resistance Counting Platform for Multiplexed and Ultrasensitive Detection of Mycotoxins and Biomarkers.
ACS Nano
January 2025
State Key Laboratory of Marine Food Processing and Safety Control, Dalian Polytechnic University, Dalian 116034 Liaoning, China.
Article Synopsis
- A novel biosensing platform has been developed using polystyrene microsphere coding and Argonaute (CbAgo) for highly sensitive detection of multiple targets in public health.
- The system employs micropore resistance counting and allows for precise decoding through DNA activation, enabling recognition and cleavage of target sequences.
- This platform shows exceptional sensitivity in detecting mycotoxins and inflammatory markers, highlighting its potential use in clinical diagnostics, food safety, and environmental monitoring.
Power-Sustainable and Portable Electrochemical Sensing Platforms for Complex Outdoor Environment Applications.
ACS Appl Mater Interfaces
January 2025
School of Integrated Circuits and Electronics, Beijing Institute of Technology, Beijing 100081, China.
Portable sensor technologies are indispensable in personalized healthcare and environmental monitoring as they enable the continuous tracking of key analytes. Human sweat contains valuable physiological information, and previously developed noninvasive sweat-based sensors have effectively monitored single or multiple biomarkers. By successfully detecting biochemicals in sweat, portable sensors could also significantly broaden their application scope, encompassing non-biological fluids commonly encountered in daily life, such as mineral water.
View Article and Find Full Text PDFDeep learning-based aberration compensation improves contrast and resolution in fluorescence microscopy.
Nat Commun
January 2025
Laboratory of High Resolution Optical Imaging, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Bethesda, Maryland, USA.
Optical aberrations hinder fluorescence microscopy of thick samples, reducing image signal, contrast, and resolution. Here we introduce a deep learning-based strategy for aberration compensation, improving image quality without slowing image acquisition, applying additional dose, or introducing more optics. Our method (i) introduces synthetic aberrations to images acquired on the shallow side of image stacks, making them resemble those acquired deeper into the volume and (ii) trains neural networks to reverse the effect of these aberrations.
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