Validation of SARS-CoV-2 pooled testing for surveillance using the Panther Fusion® system: Impact of pool size, automation, and assay chemistryArticle Published on 2022-11-072022-11-15 Journal: PLoS ONE [Category] SARS, 진단, 치료기술, [키워드] approach assays authorization automated conducted cut-off threshold cycle threshold decrease demonstrated diagnostic Emergency evaluated expected FDA FIVE generate Impact less limit of detection lowering nasopharyngeal sample nucleic acid amplification positive positive sample resources SARS-CoV-2 SARS-CoV-2 RNA sensitivity specificity specimen Surveillance surveillance testing System tested validation was used [DOI] 10.1371/journal.pone.0276729 PMC 바로가기
A precise review on NAATs-based diagnostic assays for COVID-19: A motion in fast POC molecular testsArticle Published on 2022-11-012022-11-15 Journal: European Journal of Clinical Investigation [Category] SARS, 치료기술, [키워드] addressed advance approved assist authorization Care Comparative coronavirus disease COVID-19 diagnostic Diagnostic method disease Emergency expand false-negative global pandemic Health limitation mitigate molecular molecular diagnostic assays molecular test NAAT New nucleic acid amplification nucleic acid amplification techniques parameter platform POC POC testing point-of-care Point-of-care testing. polymerase chain RT-qPCR SARS-CoV-2 Sensitivity and specificity suggested [DOI] 10.1111/eci.13853 PMC 바로가기
Utilization of the Abbott SARS-CoV-2 IgG II Quant Assay To Identify High-Titer Anti-SARS-CoV-2 Neutralizing Plasma against Wild-Type and Variant SARS-CoV-2 VirusesArticle Published on 2022-10-262022-11-15 Journal: Microbiology Spectrum [Category] COVID19(2023년), SARS, 변종, 진단, [키워드] 95% confidence interval Abbott Abbott SARS-CoV-2 IgG acute respiratory syndrome Analysis approach approach authorization BAU Beta binding antibody unit Canada CCP characterized Chicago Chicago IL clinical trial convalescent convalescent plasma coronavirus COVID-19 COVID-19 convalescent plasma Cutoff Delta disease course drug Emergency EUA evaluated Evidence experiment FDA food Gamma highest hospitalized patient Humoral immunity identify IgG immune IMPROVE Mann-Whitney U method comparisons Neutralization assay Neutralizing neutralizing antibody outcome Patient patient group plaque reduction neutralization plaque reduction neutralization. plasma PRNT quantitative determination required SARS-CoV-2 SARS-CoV-2 antibody selected significantly specimen tested the SARS-CoV-2 time-consuming treat United State utilization variant VLP VoC wild-type with COVID-19 [DOI] 10.1128/spectrum.02811-22 PMC 바로가기
Considerations for the selection of tests for SARS-CoV-2 molecular diagnosticsArticle Published on 2022-10-012022-11-15 Journal: Molecular biology reports [Category] COVID19(2023년), SARS, 유전자 메커니즘, 진단, 치료기술, 치료제, [키워드] Accuracy authorization chain clinical country Course COVID-19 criteria detect develop diagnostic Diagnostic performance diagnostic test diagnostics drug evaluated food gold standard good manufacturing practice Guidance independent Infection information Laboratory lack molecular molecular test Mutation Novel coronavirus outbreak pandemic proportion Quality control reaction real-time RT-PCR Region regions regulatory authority required respiratory SARS-CoV-2 SARS-CoV-2 test selected Spread target gene Test Test selection. variable [DOI] 10.1007/s11033-022-07455-5 PMC 바로가기
A review of clinical efficacy data supporting emergency use authorization for COVID-19 therapeutics and lessons for future pandemicsArticle Published on 2022-10-012022-11-15 Journal: Clinical and translational science [Category] COVID19(2023년), SARS, 치료제, [키워드] Anti-inflammatory Antiviral approved authorization chloroquine/hydroxychloroquine Clinical data Clinical efficacy clinical evidence clinical study clinical trial coronavirus disease COVID-19 COVID-19 pandemic COVID-19 therapeutics Critical demonstrated drug Efficacy Emergency Emergency use authorization EUA Evidence FDA food Guidance majority medication Pandemics public health emergency question Randomized controlled trial RCT Regulatory Resilience statistically significant submitted subsequent Support supported therapeutic withdrawn [DOI] 10.1111/cts.13384 PMC 바로가기
A critical overview of current progress for COVID-19: development of vaccines, antiviral drugs, and therapeutic antibodiesArticle Published on 2022-09-122022-11-15 Journal: Journal of Biomedical Science [Category] SARS, 변종, 신약개발, 치료제, [키워드] abrogated acute respiratory syndrome addition analysis antibodies antibody Antiviral antiviral drugs authorization BNT162b2 clinical benefits Clinical data clinical trial coronavirus COVID-19 Critical diagnostic distribution drug drugs Effect Effectiveness Efficacy effort Emergency global public health help Infection mRNA vaccines mRNA vaccines. mRNA-1273 mutant strain Mutation Neutralizing antibodies neutralizing antibody neutralizing effect novel coronavirus disease omicron overcome pandemic presenting problems Regulatory SARS-CoV-2 SARS-CoV-2 strains SARS-CoV-2 variant Scientific community shown small molecule Small molecule antiviral drugs small molecule drugs Support the spike protein therapeutic Therapeutics Treatment utility Vaccine Vaccine development Vaccines variant variants widespread [DOI] 10.1186/s12929-022-00852-9 PMC 바로가기
Cheminformatics-Based Discovery of Potential Chemical Probe Inhibitors of Omicron Spike ProteinArticle Published on 2022-09-072022-11-15 Journal: International Journal of Molecular Sciences [Category] SARS, 변종, 진단, 치료제, [키워드] ACE2 Antiviral compound antiviral drug authorization bind carried Chemical Compound compounds COVID-19 COVID-19 pandemic database determine DFT drug treatment effective Emergency evaluate facilitate FDA FIVE Health human Angiotensin-converting enzyme identify IMPROVE in vitro in vivo indicated Initially Invasion less Lineage MD simulation molecular monoclonal antibody mutant neutralizing monoclonal antibody omicron Potential profile Protein protein-ligand interaction provided raised reactivity receptor reduce Reinfection Replication rising risk SARS-CoV-2 SARS-CoV-2 variant SARS-CoV-2 variants spike Spread the Spike therapeutic intervention vaccination Vaccine-induced immunity variant Virtual screening virtual screening. virus virus transmission was performed [DOI] 10.3390/ijms231810315 PMC 바로가기
A How to Guide: Clinical Population Test Development and Authorization of MALDI-ToF Mass Spectrometry-Based Screening Tests for Viral InfectionsArticle Published on 2022-09-032022-11-15 Journal: Viruses [Category] 치료기술, [키워드] applied Applying Asymptomatic asymptomatic screening authorization Bacteria Bacterial CLIA CLIA-LDT clinical clinical process clinical testing COVID-19 criteria detection development diagnostic fungi Infection Laboratory limits MALDI-TOF MS mass MS test overcome pathogenic Population Population screening Proteins regulatory authority SAR-CoV-2 SARS-CoV-2 Screening Systems biology Test viral infection Viral infection. viral infections Viral protein virus virus viruses [DOI] 10.3390/v14091958 PMC 바로가기
Outcomes of pregnant patients treated with REGEN-COV during the COVID-19 pandemicArticle Published on 2022-09-012022-10-05 Journal: American journal of obstetrics & gynecology MFM [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] administration Admission adverse events anaphylaxis Atlanta authorization benefit casirivimab and imdevimab Clinical course Clinical outcome Cohort cohort of patient COVID-19 COVID-19 illness COVID-19 pandemic COVID-19 therapeutics death drug Effect Efficacy eligible Emergency food groups high-risk population higher risk Hospital stay Hospitalization Hypothesis increased risk individual Infection instance intensive care less Maternal morbidity Memorial monoclonal antibodies monoclonal antibody morbidity and mortality need for oxygen Neonatal Neonatal morbidity no significant difference nonpregnant novel therapies offered outcome outcomes Oxygen requirement patients with SARS-CoV-2 pharmacologic treatment Placebo polymerase chain positive Pregnancy pregnant pregnant patient pregnant patients pregnant population receive reduce reduced REGEN-COV released resolved Respiratory illness retrospective cohort study risk Safe SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 viral load severe COVID-19 severe disease Shortness of breath shown side statistically significant difference Symptom tested therapy thought treated Treatment treatment guideline Trial trials ventilatory support were excluded worsening [DOI] 10.1016/j.ajogmf.2022.100673 [Article Type] Article
Successful recruitment of monolingual Spanish speaking Latinos to university phase II and III outpatient COVID-19 clinical treatment trials in Northern CaliforniaClinical Trial Published on 2022-09-012022-10-05 Journal: Contemporary clinical trials [Category] 유전자 메커니즘, 임상, 진단, 치료법, [키워드] authorization Clinical treatment clinical trial contribute COVID-19 Emergency Enrollment EUA FDA Health Latino Mild Moderate COVID-19 monoclonal antibody Outpatient patients Population receive recruited recruitment research coordinator Spanish Stanford University Treatment treatment trial Trial with COVID-19 [DOI] 10.1016/j.cct.2022.106891 [Article Type] Clinical Trial