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1.
mSphere ; 6(3)2021 05 12.
Article in English | MEDLINE | ID: mdl-33980676

ABSTRACT

Serology (antibody) tests to detect previous SARS-CoV-2 infection have been in high demand from the beginning of the COVID-19 pandemic. The initial shortage of diagnostic tests coupled with asymptomatic infections led to a significant demand for serology tests to identify past infections. Despite serious limitations on the interpretation of a positive antibody test in terms of immunity to SARS-CoV-2, antibody testing was initially considered for release from social distancing, return to employment, and "immunity passports." The regulatory approach to antibody tests was limited; manufacturers were encouraged to develop and market antibody tests without submitting validation data to the FDA. FDA guidance grew more stringent, but many poor-quality tests were already on the market-potentially inappropriately used for individual decision-making. This is a case study describing COVID-19 serology tests and the U.S. market and describes lessons learned for a future health security crisis.


Subject(s)
Antibodies, Viral/blood , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Pandemics , SARS-CoV-2/immunology , Asymptomatic Infections , COVID-19 Serological Testing/history , COVID-19 Serological Testing/standards , Forecasting , Health Policy , Health Services Needs and Demand , History, 21st Century , Humans , Immunoglobulin G/blood , Immunoglobulin M/blood , Marketing of Health Services , Politics , Quality Control , Sensitivity and Specificity , United States , United States Food and Drug Administration , Validation Studies as Topic
2.
Perspect Biol Med ; 63(1): 73-92, 2020.
Article in English | MEDLINE | ID: mdl-32063588

ABSTRACT

CRISPR, a powerful gene-editing technology, is revolutionizing the life sciences and medical research. The technology has also become democratized. Costs to use CRISPR are low and decreasing, kits are available to make the use of CRISPR straightforward, and there is a rapidly growing scientific literature describing CRISPR methodologies and novel applications. However, like other powerful advances in the life sciences, CRISPR raises biosecurity concerns: it could be misused for harm, and it lowers technical barriers to biological weapons development. This essay describes the history and dissemination of CRISPR as genome-editing techniques have become widespread, outlines potential biosecurity concerns, and recommends actions governments and scientists may take to reduce biosecurity risks. While it is not possible to eliminate biosecurity risks from the misuse of biotechnologies, including CRISPR, steps can be taken to increase security while allowing this powerful technology to remain widely available for beneficent purposes.


Subject(s)
Clustered Regularly Interspaced Short Palindromic Repeats , Gene Drive Technology , Gene Editing , Animals , Anopheles/genetics , Bacteria/genetics , Containment of Biohazards , Crops, Agricultural/genetics , Eukaryotic Cells , Female , Humans
3.
Nanoscale Adv ; 1(2): 671-685, 2019 Feb 12.
Article in English | MEDLINE | ID: mdl-36132237

ABSTRACT

Sustained and safe delivery of therapeutic agents across the blood-brain barrier (BBB) is one of the major challenges for the treatment of neurological disorders as this barrier limits the ability of most drug molecules to reach the brain. Targeted delivery of the drugs used to treat these disorders could potentially offer a considerable reduction of the common side effects of their treatment. The preparation and characterization of carboxymethyl cellulose (CMC) coated magnetic nanoparticles (Fe3O4@CMC) is reported as an alternative that meets the need for novel therapies capable of crossing the BBB. In vitro assays were used to evaluate the ability of these polysaccharide coated biocompatible, water-soluble, magnetic nanoparticles to deliver drug therapy across a model of the BBB. As a drug model, dopamine hydrochloride loading and release profiles in physiological solution were determined using UV-Vis spectroscopy. Cell viability tests in Human Lung Microvascular Endothelial (HLMVE) cell cultures showed no significant cell death, morphological changes or alterations in mitochondrial function after 24 and 48 h of exposure to the nanoparticles. Evidence of nanoparticle interactions and nanoparticle uptake by the cell membrane was obtained by electron microscopy (SEM and TEM) analyses. Permeability through a BBB model (the transwell assay) was evaluated to assess the ability of Fe3O4@CMC nanoparticles to be transported across a densely packed HLMVE cell barrier. The results suggest that these nanoparticles can be useful drug transport and release systems for the design of novel pharmaceutical agents for brain therapy.

4.
CNS Neurol Disord Drug Targets ; 16(7): 749-762, 2017.
Article in English | MEDLINE | ID: mdl-28745241

ABSTRACT

BACKGROUND & OBJECTIVE: Epilepsy is one of the most complex neurological disorders and its study requires a broad knowledge of neurology and neuroscience. It comprises a diverse group of neurological disorders that share the central feature of spontaneous recurrent seizures, and are often accompanied by cognitive deficits and mood disorder. This condition is one of the most common neurological disorders. Until recently, alterations of neuronal activities had been the focus of epilepsy research. This neurocentric emphasis did not address issues that arise in more complex models of epileptogenesis. An important factor in epilepsy that is not regulated directly by neurons is inflammation and the immune response of the brain. Recent evidence obtained in rodent epilepsy models supports the role of immune responses in the initiation and maintenance of epilepsy. Recognition of exogenous pathogens by the innate immune system is mediated by some pattern recognition receptors such as Toll-like receptors leading to cell activation and cytokine production. Currently, these receptors have been the focus of epilepsy studies looking to determine whether the innate immune activation is neuroprotective or neurotoxic for the brain. CONCLUSION: Here, we present the evidence in the literature of the involvement of key innate immune receptors in the development of epilepsy. We address some of the contradictory findings in these studies and also mention possible avenues for research into epilepsy treatments that target these receptors.


Subject(s)
Epilepsy/physiopathology , Immunity, Innate/physiology , Receptors, Immunologic/physiology , Animals , Humans , Molecular Targeted Therapy/methods , Receptors, Immunologic/drug effects
5.
CNS Neurol Disord Drug Targets ; 15(10): 1306-1324, 2016.
Article in English | MEDLINE | ID: mdl-27488421

ABSTRACT

Despite the numerous challenges associated with the application of nanotechnology in neuroscience, it promises to have a significant impact on our understanding of how the nervous system works, how it fails in disease, and the development of earlier and less-invasive diagnostic procedures so we can intervene in the pre-clinical stage of neurological disease before extensive neurological damage has taken place. Ultimately, both the challenges and opportunities that nanotechnology presents stem from the fact that this technology provides a way to interact with neural cells at the molecular level. In this review we provide a neurobiological overview of key neurological disorders, describe the different types of nanomaterials in use and discuss their current and potential uses in neuroscience. We also discuss the issue of toxicity in these nanomaterials. This review presents many of the different applications that advances in nanotechnology are having in the field of neurological sciences, especially the high impact they are having in the development of new treatment modalities for neurological disorders that will induce the expected physiological response while minimizing undesirable secondary effects. In conclusion, we weigh in on what the promises and challenges are for future development in this groundbreaking field.


Subject(s)
Nanostructures/therapeutic use , Nervous System Diseases/therapy , Neurology , Animals , Humans
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