Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and...Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and'Assay'.Identification of botanical material is achieved by macroscopic and microscopic morphology,generally examined by a trained expert.Content or assay is the most difficult area of展开更多
Introduction:Emerging and re-emerging transfusion-transmitted arboviruses remain a persistent public health challenge to global blood safety.This study aims to establish a comprehensive nucleic acid testing(NAT)qualit...Introduction:Emerging and re-emerging transfusion-transmitted arboviruses remain a persistent public health challenge to global blood safety.This study aims to establish a comprehensive nucleic acid testing(NAT)quality control system for Dengue virus(DENV),Zika virus(ZIKV),and Chikungunya virus(CHIKV)screening in blood donations to evaluate the performance of domestic screening reagents,and to assess the prevalence of these arboviruses in border regions.Methods:Pseudovirus quality control materials based on the Moloney murine leukemia virus(MMLV)vector was constructed to evaluate the limit of detection(LoD)and precision of six blood screening reagents.An external quality assessment(EQA)was conducted across eight central blood stations in Guangxi Zhuang Aotonomous Region and Yunnan Provinces.These blood stations employed either reagent A or E for DENV/ZIKV/CHIKV triplex-assay screening of blood donor samples collected during epidemic seasons(June–August)in 2022 and 2023.Results:The six reagents exhibited varied LoD.All evaluated reagents exhibited excellent precision with coefficient of variation(CV)values<5%.All eight central blood stations achieved EQA scores above 80.In 2022,a total of 45,383 blood samples were screened,with no positive cases detected.In 2023,44,972 blood donors were screened,and nine samples tested positive at the Xishuangbanna central blood station.Confirmatory testing verified six Dengue virus serotype 1(DENV-1)infections among these cases.Conclusions:This study successfully established a robust quality assurance system for NAT-based arbovirus screening in China.The detection of DENV-positive samples underscore the persisting risk of transfusion-transmitted infections in endemic regions.Continued surveillance and enhanced screening strategies are essential to safeguard blood safety,particularly in arboviral hotspot regions with tropical/subtropical climates prone to recurrent outbreaks.展开更多
文摘Phar.Eur.Herbal Drug(HD)monographs state which aspects have to be considered for quality assurance through the relevant chapters'Definition'.'Characters','Identification','Tests',and'Assay'.Identification of botanical material is achieved by macroscopic and microscopic morphology,generally examined by a trained expert.Content or assay is the most difficult area of
基金Supported by the CAMS Innovation Fund for Medical Sciences(CIFMS)(2021-I2M-1-060).
文摘Introduction:Emerging and re-emerging transfusion-transmitted arboviruses remain a persistent public health challenge to global blood safety.This study aims to establish a comprehensive nucleic acid testing(NAT)quality control system for Dengue virus(DENV),Zika virus(ZIKV),and Chikungunya virus(CHIKV)screening in blood donations to evaluate the performance of domestic screening reagents,and to assess the prevalence of these arboviruses in border regions.Methods:Pseudovirus quality control materials based on the Moloney murine leukemia virus(MMLV)vector was constructed to evaluate the limit of detection(LoD)and precision of six blood screening reagents.An external quality assessment(EQA)was conducted across eight central blood stations in Guangxi Zhuang Aotonomous Region and Yunnan Provinces.These blood stations employed either reagent A or E for DENV/ZIKV/CHIKV triplex-assay screening of blood donor samples collected during epidemic seasons(June–August)in 2022 and 2023.Results:The six reagents exhibited varied LoD.All evaluated reagents exhibited excellent precision with coefficient of variation(CV)values<5%.All eight central blood stations achieved EQA scores above 80.In 2022,a total of 45,383 blood samples were screened,with no positive cases detected.In 2023,44,972 blood donors were screened,and nine samples tested positive at the Xishuangbanna central blood station.Confirmatory testing verified six Dengue virus serotype 1(DENV-1)infections among these cases.Conclusions:This study successfully established a robust quality assurance system for NAT-based arbovirus screening in China.The detection of DENV-positive samples underscore the persisting risk of transfusion-transmitted infections in endemic regions.Continued surveillance and enhanced screening strategies are essential to safeguard blood safety,particularly in arboviral hotspot regions with tropical/subtropical climates prone to recurrent outbreaks.
