Design and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)새로운 SARS-CoV-2 항바이러스제 시험을 위한 국제, 다군, 다단계 플랫폼 마스터 프로토콜의 설계 및 구현: COVID-19 입원 환자를 위한 치료제(TICO/ACTIV-3)Article Published on 2022-02-012022-09-11 Journal: Clinical Trials (London, England) [Category] 임상, 치료제, [키워드] adults hospitalized agent Antiviral Antiviral agents applicability approach approaches approval clinical trial collaboration Consent Forms COVID-19 Data collection drug effective therapy Efficacy enrolled Evidence evidence of expected facilitate feature FIVE food Food and Drug Administration forms harmonization hospitalized patient hospitalized patients implementation infection rate infection rates information initiated Inpatient Inpatients International matching placebo multi-arm multi-arm multi-stage Other outbreak overcome participant participated Patient Placebo platform platform trials. potential therapeutic agent potential therapeutic agents protocol provided Randomized Rapid recruitment Regulatory required robust safety evaluation Safety Monitoring Board safety profile Sample size SARS-CoV-2 Stage subsequent target population therapeutic agent Therapeutics Trial trials with COVID-19 [DOI] 10.1177/17407745211049829 PMC 바로가기 [Article Type] Article
Development and Validation of a Novel HPLC Method to Analyse Metabolic Reaction Products Catalysed by the CYP3A2 Isoform: In Vitro Inhibition of CYP3A2 Enzyme Activity by Aspirin (Drugs Often Used Together in COVID-19 Treatment)Article Published on 2022-01-292022-10-30 Journal: Molecules [Category] Coronavirus, SARS, [키워드] 6β-hydroxydexamethasone Accuracy activity applied Aspirin bridge Chromatography competitive inhibitor Concentration COVID-19 CYP3A activity CYP3A2 cytochrome P450 development Dexamethasone drug drug interaction enzyme activity evaluate Fever harmonization healthcare HPLC ICH in vitro indicated Inflammation inhibit inhibition inhibitor International Conference limit limit of detection liquid liver metabolic moderate novel Pain Precision product quantification reaction reversed risk Severe case stability Toxicity treat validation [DOI] 10.3390/molecules27030927 PMC 바로가기 [Article Type] Article
New-Generation Quantitative Immunoassays for SARS-CoV-2 Antibody Detection: Need for HarmonizationSARS-CoV-2 항체 검출을 위한 차세대 정량 면역 측정법: 조화의 필요성Article Published on 2022-01-012022-09-11 Journal: Annals of laboratory medicine [Category] SARS, 진단, 치료기술, [키워드] harmonization SARS-CoV-2 [DOI] 10.3343/alm.2022.42.1.113 PMC 바로가기 [Article Type] Article
Harmonized D-dimer levels upon admission for prognosis of COVID-19 severity: Results from a Spanish multicenter registry (BIOCOVID-Spain study)COVID-19 심각도의 예후를 위해 입원 시 조화된 D-dimer 수준: 스페인 다기관 등록의 결과(BIOCOVID-스페인 연구)Multicenter Study Published on 2022-01-012022-09-11 Journal: Journal of Thrombosis and Thrombolysis [Category] 바이오마커, [키워드] adjusted hazard ratio Admission an area Analysis approach assays association characteristic Clinical practice Coagulopathy comparability COVID-19 COVID-19 patients Cox regression analysis cut-off value D-dimer D-dimer level D-dimer levels death defined dimer Endpoint FEU greater harmonization hospital mortality rate in-hospital mortality in-hospital mortality rate independent Mortality mortality rate multicenter patients Prognosis prognostic receiver operating characteristic regression line reported Result Retrospective multicenter study risk severity Spanish study population test results transformation translate was performed [DOI] 10.1007/s11239-021-02527-y PMC 바로가기 [Article Type] Multicenter Study
The WHO International Standard for COVID-19 serological tests: towards harmonization of anti-spike assaysArticle Published on 2021-11-012023-06-19 Journal: International immunopharmacology [Category] MERS, SARS, [키워드] anti-SARS-CoV-2 antibodies COVID-19 COVID-19 serological testing harmonization Serological tests WHO International Standard [DOI] 10.1016/j.intimp.2021.108095 PMC 바로가기
Harmonization of six quantitative SARS-CoV-2 serological assays using sera of vaccinated subjects백신 접종 대상자의 혈청을 사용한 6가지 정량적 SARS-CoV-2 혈청학적 분석의 조화Article Published on 2021-11-012022-09-12 Journal: Clinica chimica acta; international journal of cli [Category] MERS, SARS, 진단, [키워드] Antibody titer Antibody titers assays Characteristics Comirnaty vaccine complement correlation COVID-19 facilitate Factor harmonization IgG individuals limit material neutralization neutralization activity performed predict produced Quantitative reproducibility SARS-CoV-2 SARS-COV-2 infection sera serological Serological assay Serological standard serum sample subject tested vaccinated individual Variability were used WHO WHO. [DOI] 10.1016/j.cca.2021.08.024 PMC 바로가기 [Article Type] Article
Antibodies against SARS-CoV-2 Time Course in Patients and Vaccinated Subjects: An Evaluation of the Harmonization of Two Different MethodsArticle Published on 2021-09-182022-10-31 Journal: Diagnostics [Category] COVID-19, [키워드] anti-RBD antibody BAU booster chemiluminescence immunoassay collected Concentration Course decrease detectable eight ELISA evaluated Evidence first dose harmonization IgG immune response IMPROVE less method comparison onset of symptom Patient patients patients with COVID-19 reduced remained SARS-CoV-2 SARS-CoV-2 antibody response second dose second vaccination significant increase specimen subject subjects Symptoms the antibody time vaccination [DOI] 10.3390/diagnostics11091709 PMC 바로가기 [Article Type] Article
Immunophenotyping assessment in a COVID-19 cohort (IMPACC): A prospective longitudinal studyCovid-19 코호트 (IMPACC)에서의 면역 표현형 평가 : 전향 적 종단 연구Multicenter Study Published on 2021-08-102022-09-10 Journal: Science Immunology [Category] MERS, SARS, 바이오마커, 유전자 메커니즘, 진단, [키워드] analyses assays assessment biologic Biomarker Biomarkers Blood clinical Clinical and laboratory data clinical criteria Course COVID-19 COVID-19 cohort description Disease progression effective feature generate genomic harmonization hospitalized patient hospitalized patients Host immune response host immune responses hypothese hypotheses identify immune responses Immunophenotyping Laboratory laboratory data longitudinal study manifestation metabolomic multicenter multisite pathogen processing proteomic protocol protocols Radiographic recruitment respiratory secretion severity Study design susceptibility with COVID-19 [DOI] 10.1126/sciimmunol.abf3733 PMC 바로가기 [Article Type] Multicenter Study
Performance of the Abbott SARS-CoV-2 IgG II Quantitative Antibody Assay Including the New Variants of Concern, VOC 202012/V1 (United Kingdom) and VOC 202012/V2 (South Africa), and First Steps towards Global Harmonization of COVID-19 Antibody Methods우려의 새로운 변종, VOC 202012/V1(영국) 및 VOC 202012/V2(남아프리카)를 포함한 Abbott SARS-CoV-2 IgG II 정량적 항체 분석의 성능, COVID-19 항체의 글로벌 조화를 향한 첫 단계 행동 양식Immunoassays Published on 2021-07-142022-09-10 Journal: Journal of Clinical Microbiology [Category] MERS, SARS, 변종, 진단, 치료법, [키워드] Abbott Abbott SARS-CoV-2 IgG acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 analytical performance anti-SARS-CoV-2 anti-SARS-CoV-2 IgG antibody assay Antigen appear binding clinical decision comprehensive evaluation concern Concordance coronavirus correlation COVID-19 COVID-19 pandemic Decision making evaluated Evaluation generate harmonization IgG immune response Including initial initial stages introduced lack linear natural infection New nucleocapsid protein Nucleocapsid proteins parameter performance performed plethora positive protocols Quantitative reference material Reference materials respiratory response reverse transcription-PCR RT-PCR SARS-CoV-2 sensitivity serology serology test severe acute respiratory syndrome Coronavirus South Africa specificity Spike protein Stage step tested the spike protein Trial United Kingdom variants VoC were assessed [DOI] 10.1128/JCM.00288-21 PMC 바로가기 [Article Type] Immunoassays
Assessing the Quality of Serological Testing in the COVID-19 Pandemic: Results of a European External Quality Assessment (EQA) Scheme for Anti-SARS-CoV-2 Antibody DetectionCOVID-19 팬데믹에서 혈청학적 검사의 품질 평가: Anti-SARS-CoV-2 항체 검출을 위한 유럽 외부 품질 평가(EQA) 계획의 결과Immunoassays Published on 2021-06-302022-09-10 Journal: Journal of Clinical Microbiology [Category] MERS, SARS, 진단, 치료기술, [키워드] anti-SARS-CoV-2 anti-SARS-CoV-2 antibodies anti-SARS-CoV-2 antibody anti-SARS-CoV-2 IgG Antibody detection Antibody titers Assessing assessment blinded country COVID-19 COVID-19 pandemic Cutoff detection diagnostic diagnostic procedures diagnostic sensitivity diagnostics distribution drop EQA Europe European External external quality assessment scheme harmonization help highlight human serum IgA IgG IgM IgM antibodies Immunity immunoassays IMPROVE Improvements Laboratory lack limitation management offer open Prevalence proficiency testing provided Quality recommendation reference reported Result ring trial SARS-CoV-2 SARS-COV-2 infection sensitivity Sensitivity and specificity serological serological test Serological tests serum samples technical limitations test performance test results Testing vaccine response Variability [DOI] 10.1128/JCM.00559-21 PMC 바로가기 [Article Type] Immunoassays