Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2Article Published on 2024-12-312024-09-02 Journal: Pharmeur Bio Sci Notes [Category] 파상풍, [키워드] European Pharmacopoeia international standard potency Quality control reference standard Tetanus immunoglobulin PMC 바로가기
Collaborative study for the establishment of Ph. Eur. Biological Reference Preparation for Human tetanus immunoglobulin batch 2Article Published on 2024-12-312024-09-02 Journal: Pharmeur Bio Sci Notes [Category] 파상풍, [키워드] European Pharmacopoeia international standard potency Quality control reference standard Tetanus immunoglobulin PMC 바로가기
Collaborative study for the calibration of a replacement International Standard for tetanus toxoid for use in flocculation testarticle Published on 2023-11-302024-09-01 Journal: Biologicals [Category] 파상풍, [키워드] antigenicity Flocculation international standard tetanus toxoid tetanus vaccine [Article Type] article
A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in TaiwanArticle Published on 2022-09-012022-11-15 Journal: Biologicals : journal of the International Associa [Category] SARS, 치료기술, [키워드] acute respiratory syndrome addition amplification assays coronavirus detect facilitate international standard International standard (IS) Laboratory NAAT National National standard (NS) nucleic acid amplification Nucleic acid amplification techniques (NAAT) PCR provided RNA copy numbers SARS-CoV-2 SARS-CoV-2 RNA severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Standardization Taiwan the SARS-CoV-2 virus genome whole-genome sequencing [DOI] 10.1016/j.biologicals.2022.08.002 PMC 바로가기
Harmonization of SARS-CoV-2 reverse transcription quantitative PCR tests to the first WHO international standard for SARS-CoV-2 RNASARS-CoV-2 RNA에 대한 최초의 WHO 국제 표준에 SARS-CoV-2 역전사 정량 PCR 테스트의 조화Article Published on 2022-09-012022-09-11 Journal: Journal of Clinical Virology [Category] COVID19(2023년), SARS, 유전자 메커니즘, 치료법, [키워드] 95% CI 95% confidence interval Analysis assays association calibration Cepheid clinical samples comparable confidence Ct value Ct values cycle cycle threshold Emergency use evaluate Generalizability generate greater harmonization IMPROVE International international standard interquartile range interval IQR log mean difference median nucleocapsid platform positive quantitation Quantitative quantitative PCR Range Regression reverse transcription RT-qPCR RT-qPCRs SARS-CoV-2 SARS-CoV-2 RNA Standard target targets the mean the WHO threshold upper respiratory viral burden was tested WHO [DOI] 10.1016/j.jcv.2022.105242 PMC 바로가기 [Article Type] Article
Complexity of serological assays and misunderstandings of WHO International UnitsComment Published on 2022-07-202023-07-10 Journal: Clinical chemistry and laboratory medicine [Category] COVID19(2023년), [키워드] COVID-19 international standard international unit SARS-CoV-2 immunoglobulin WHO [DOI] 10.1515/cclm-2022-0660 [Article Type] Comment
Overview of Neutralization Assays and International Standard for Detecting SARS-CoV-2 Neutralizing AntibodySARS-CoV-2 중화 항체 검출을 위한 중화 분석 및 국제 표준 개요Review Published on 2022-07-182022-09-11 Journal: Viruses [Category] COVID19(2023년), MERS, SARS, 진단, 치료기술, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Antibody Response Antibody responses Antibody titer approach coronavirus coronavirus disease demonstrated detect determine disease disease outbreak Efficacy ELISA enzyme enzyme-linked immunosorbent enzyme-linked immunosorbent assay Health Organization International international standard international standard for SARS-CoV-2 International standards lateral flow microneutralization Microneutralization assay MONITOR Neutralization assay neutralization assays Neutralizing antibodies neutralizing antibody neutralizing antibody detection Neutralizing antibody titer outbreak outcome Patient respiratory SARS-CoV-2 SARS-CoV-2 pseudotype virus Serological assay serological assays severe acute respiratory syndrome Coronavirus Standard to define Vaccine vaccine efficacy World Health Organization [DOI] 10.3390/v14071560 PMC 바로가기 [Article Type] Review
Exploratory assessment of serological tests to determine antibody titer against SARS-CoV-2: Appropriateness and limitsSARS-CoV-2에 대한 항체가를 결정하기 위한 혈청학적 검사의 탐색적 평가: 적절성 및 한계Multicenter Study Published on 2022-05-012022-09-11 Journal: Journal of Clinical Laboratory Analysis [Category] COVID19(2023년), MERS, SARS, 진단, 치료기술, [키워드] Analysis analyzed antibody Antibody titer Antibody titers appropriateness can be used Definition detect determine diagnostic diagnostic test diagnostic tests effective Effectiveness Elecsy Elecsys evaluated Health highlight IgA immunoassay Immunoglobulin immunoglobulins Infection International international standard International standards laboratory data limit limitation Luminex xMAP multicenter multiplex Multiplex assay multiplicity RBD resulting Roche S1 domain SARS-CoV-2 SARS-CoV-2 IgG SARS-COV-2 infection SARS-CoV-2 spike protein SARS-CoV-2 test SARS-CoV-2 tests selected serological serological test Serological tests serum serum sample serum samples Siemen Spike protein Standard subject subjects the SARS-CoV-2 the WHO titer to define vaccination Variability WHO [DOI] 10.1002/jcla.24363 PMC 바로가기 [Article Type] Multicenter Study
Establishment of an in-house real-time RT-PCR assay for the detection of severe acute respiratory syndrome coronavirus 2 using the first World Health Organization international standard in a resource-limited country자원이 제한된 국가에서 최초의 세계보건기구 국제표준을 이용한 중증급성호흡기증후군 코로나바이러스 2 검출을 위한 사내 실시간 RT-PCR 분석법 구축Article Published on 2022-05-012022-09-11 Journal: Journal of Clinical Laboratory Analysis [Category] COVID19(2023년), SARS, 치료기술, 치료제, [키워드] acute respiratory syndrome caused Clinical performance clinical sample clinical samples conserved coronavirus correlation country COVID-19 COVID-19 pandemic Critical E gene evaluated house International international standard limit of detection molecular molecular assays multiplex N gene Nasopharyngeal samples Nasopharyngeal swab nasopharyngeal swabs NIBSC Patient PCR assay positive Primers probe probes public health real-time RT-PCR reference standard Region RT-PCR assay Saliva SARS-CoV-2 specimen Standard Target genes WHO World Health Organization [DOI] 10.1002/jcla.24355 PMC 바로가기 [Article Type] Article
Diagnostic Value of a SARS-CoV-2 Rapid Test Kit for Detection of Neutralizing Antibodies as a Point-of-Care Surveillance Test현장 감시 검사로서 중화 항체 검출을 위한 SARS-CoV-2 신속 검사 키트의 진단 가치Article Published on 2022-04-272022-09-11 Journal: Microbiology Spectrum [Category] COVID19(2023년), MERS, SARS, 진단, 치료기술, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 addition antibody Antibody test antibody tests Antibody titer Antibody titers assays caused Characteristics Cohort Concentration convalescence coronavirus coronavirus disease Coronavirus disease 2019 correlated COVID-19 COVID-19 symptoms cross-reactivity defined demonstrated detect detection diagnostic diagnostic test diagnostic tests display epidemiological evaluate evaluated Health Organization humoral Humoral response IgG and IgM IgG antibodies IgG test IgM antibodies immune protection immunization implementation increasingly individual Infection intensity international standard Interpretation limit of detection Live virus microneutralization NAb NAb titers NAbs Neutralizing antibodies neutralizing antibody observé pandemic point-of-care population surveillance Predictive profiles public health measure public health measures Rapid Rapid diagnostic test Rapid tests RDT RDTs recovered COVID-19 patient reducing mortality respiratory reveal SARS-CoV-1 SARS-CoV-2 SARS-CoV-2 IgG SARS-CoV-2 IgG antibodies SARS-CoV-2 IgG antibody sensitivity Serological assay Seropositivity severe acute respiratory syndrome Coronavirus specificity Standard Surveillance symptomatic infection Test test line the SARS-CoV-2 the WHO Transmission Vaccinations value was determined while WHO World Health Organization [DOI] 10.1128/spectrum.00993-21 PMC 바로가기 [Article Type] Article