A5040135006- Microfluidic and Bio-sensing Technologies
- SARS-CoV-2 and COVID-19 Research
- Single-cell and spatial transcriptomics
- COVID-19 Clinical Research Studies
- SARS-CoV-2 detection and testing
- CAR-T cell therapy research
- Extracellular vesicles in disease
- Advanced Biosensing Techniques and Applications
- Viral gastroenteritis research and epidemiology
- Monoclonal and Polyclonal Antibodies Research
- CRISPR and Genetic Engineering
- Clinical Laboratory Practices and Quality Control
- Viral Infections and Outbreaks Research
- Biosimilars and Bioanalytical Methods
- Pharmaceutical studies and practices
- Cell Image Analysis Techniques
- Health Systems, Economic Evaluations, Quality of Life
- Viral Infections and Immunology Research
- Pluripotent Stem Cells Research
National Institute of Standards and Technology
2021-2025
National Institute of Standards
2025
COVID-19 is an ongoing, global pandemic caused by the novel, highly infectious SARS-CoV-2 virus. Efforts to mitigate effects of SARS-CoV-2, such as mass vaccination and development monoclonal therapeutics, require precise measurements correlative, functional neutralizing antibodies that block virus infection. The rapid, safe, easy-to-use neutralization assays essential for faster diagnosis treatment. Here, we developed a vesicular stomatitis (VSV)-based assay with two readout methods,...
Harmonizing serology measurements (i.e., rendering them interchangeable) is critical for comparing results across different diagnostics platforms, developing associated reference materials, and thereby informing medical decisions. However, the theoretical foundations of such tasks have yet to be fully explored in terms antibody thermodynamics uncertainty quantification (UQ). In context SARS-CoV-2, example, this has restricted usefulness standards currently deployed, limited scope materials...
The number of techniques to measure concentrations and size distributions submicrometer particles has recently increased. Submicrometer particle standards are needed improve the accuracy reproducibility these techniques. fluorescently labeled polystyrene sphere suspensions with nominal 100 nm, 200 nm 500 diameters were measured using seven different Diameter values also where possible. diameter found agree within 20%, but concentration differed by as much a factor two. Accuracy related...
COVID-19 has highlighted challenges in the measurement quality and comparability of serological binding neutralization assays. Due to many different assay formats reagents, these measurements are known be highly variable with large uncertainties. The development WHO international standard (WHO IS) other pool standards have facilitated through normalization a common material but does not provide harmonization nor uncertainty quantification. In this paper, we present results from an...
Flow cytometry allows to characterize nanoparticles (NPs) and extracellular vesicles (EVs) but results are often expressed in arbitrary units of fluorescence. We evaluated the precision accuracy molecules equivalent soluble fluorophores (MESF) beads for calibration NPs EVs. Firstly, two FITC-MESF bead sets, 2 6 um size, were measured on three flow cytometers. showed that could not be compared between instruments after calibration, comparable FITC MESF achieved. However, sets displayed...
A stochastic model of the flow cytometer measurement process was developed to assess nature observed coefficient variation (CV%) mean fluorescence intensity (MFI) from a population labeled microspheres (beads). Several sources variability were considered: total number labels on bead, path through laser beam, optical absorption cross-section, quantum yield, numerical aperture collection optics, and photoelectron conversion efficiency photomultiplier (PMT) cathode. The in bead had largest...
Abstract Flow cytometry is commonly used to characterize nanoparticles (NPs) and extracellular vesicles (EVs) but results are often expressed in arbitrary units indicate fluorescence intensity. This hampers interlaboratory inter-platform comparisons. We investigated the use of molecules equivalent soluble fluorophores (MESF)-beads for assignment values NPs EVs by comparing two FITC-MESF bead sets as calibrators on different flow platforms (BD Influx ™ , CytoFLEX LX SORP BD FACSCelesta )....
Measurements, technologies, and standards accelerate the development translation of regenerative medicine products, including cell gene therapies. NIST hosts multiple consortia (e.g., Flow Cytometry Standards Consortium [FCSC],1 Genome Editing Consortium,2 Rapid Microbial Testing Methods Consortium3), each addressing a set specific challenges via collaborative approach aimed to develop measurement solutions standards. A major component is large-scale interlaboratory studies (ILSs) designed...
Viral vectors are agents enabling gene transfer and genome editing have widespread utility across the healthcare biotechnology sectors. In January 2023, International Bureau for Weights Measures’ Consultative Committee Amount of Substance (CCQM) held a workshop on Metrology systems as molecular tools. The brought together international leaders from regulatory, industry, government science, metrology sectors to better understand key challenges community: Exploring current limitations in...
Although several genome editing options are available, CRISPR/Cas9 is one of the most commonly used systems for protein and advanced therapies. There some long-term data regarding genomic phenotypic stability, however, information sparse. Flow cytometry can offer a method to characterize these edited cells longitudinal studies. The objective this work describe protocol using flow measure edits from on well-characterized B-lymphoblast cell line, GM24385, with goal supporting safe effective...