作者: Wang, Fang ; Hou, Tieying ; Li, WeiXuan ; Wei, QiuJing ; Qiu, Yurong ; Pan, Jie ; Dai, WeiLiang ; Li, Min ; Li, Xin ; Chen, ZhanZe ; Hu, Honghai ; Li, Ling ; Zhou, Hui ; Lao, XiaoBin ; He, Min ; Zhang, Ling

INTRODUCTIONndirect immunofluorescence assay (IFA) using HEp-2 as substrate plays a consolidate role for the detection and measurement of ANA, which is currently considered as the reference method for detection. Manual operation is still very common in China, therefore, the need of standardization and automation for ANA-IFA detecting has been highlighted.OBJECTIVEThe current multi-center study is aimed to evaluate if HELIOS (AESKU Diagnostics, Wendelsheim, Germany) contributes to comparability of ANA screening results among different labs，and establish application specification of HELIOS for standardization of ANA detection.METHODSANA detection by manual IFA method and HELIOS on 230 clinical serum samples in eight laboratories. The performance to discriminate positive/negative screening results, endpoint titer estimation and pattern recognition were evaluated in HELIOS and manual visual.RESULTSThe positive coincident rate for ANA detection by manual IFA ranges from 87.7% to 97.8%, the negative coincidence rate ranges from 68.8% to 100%, the correctly estimated titer evaluation were 80 to 171 cases, the correct pattern in 146 to 161 cases, respectively. The positive coincident rate of HELIOS for ANA detection ranges from 91.2% to 97.7%, the negative coincidence rate ranges from 96.5% to 100%, the correctly estimated titer evaluation were 145 to 157 cases, the correct pattern in 123 to 140 cases, respectively.CONCLUSIONHELIOS could provide accurate diagnostic results, this include not only positive/negative results, but also endpoint titer, common patterns. The application of this system can help to promote standardization of ANA detection.

Predictive values of multiple serum biomarkers in women with suspected preeclampsia: a prospective study

作者: Zhao, Juan ; Cao, Zheng ; Wang, Jing ; Zhang, Chunhong ; Zhong, Junhui ; Liu, Xiaowei ; Xie, Xin ; Zhao, Shenglong ; Chen, Lu ; Zhao, Zhen ; Liu, Jingrui ; Zheng, Yuanyuan ; Lu, Yifan ; Hu, Honghai ; Zhai, Yanhong ; Jia, Zhaoxia ; Dong, Ying

AbstractBackground: Preeclampsia prediction improves maternal and fetal outcomes in pregnancy. We aimed to evaluate the preeclampsia prediction values of a series of serum biomarkers. Methods: Singleton pregnant women with preeclampsia-related clinical and/or laboratory presentations were recruited and had blood drawn at their first visits. The prospective cohort was further divided into preeclampsia-positive and preeclampsia-negative groups based on the follow-up results. The following markers were tested using the collected serum samples: soluble fms-like tyrosine kinase-1 ( sFlt-1); placental growth factor (PlGF); thrombomodulin (TM); tissue plasminogen activator inhibitor complex (tPAI-C); compliment factors C1q, B, and H; glycosylated fibronectin (GlyFn); pregnancy-associated plasma protein-A2 ( PAPP-A2); blood urea nitrogen (BUN); creatinine (Cre); uric acid (UA); and cystatin C (Cysc). Results: A total of 196 women with suspected preeclampsia were recruited with follow-up medical records. Twenty-five percent (n=49) of the recruited subjects developed preeclampsia before delivery, and 75% remained preeclampsia-negative (n=147). The serum levels of sFlt-1, BUN, Cre, UA, Cysc and PAPP-A2 were significantly elevated, and the PlGF level was significantly decreased in the preeclampsia-positive patients. In the receiver operating characteristics (ROC) analyses, the area under the curves were listed in the order of decreasing values: 0.73 (UA), 0.67 (sFlt-1/PlGF), 0.66 (Cysc), 0.65 (GlyFn/PlGF), 0.64 (PAPP-A2/PlGF), 0.63 (BUN), 0.63 (Cre), and 0.60 (PAPP-A2). With the cut-off values obtained from the ROC analyses, the positive predictive values of these serum markers were between 33.1% and 58.5%, and the negative predictive values were between 80.9% and 89.5%. Conclusions: Further studies are warranted to confirm the clinical utilities of the serum markers in preeclampsia prediction

Predictive values of multiple serum biomarkers in women with suspected preeclampsia: a prospective study

作者: Zhao, Juan ; Cao, Zheng ; Wang, Jing ; Zhang, Chunhong ; Zhong, Junhui ; Liu, Xiaowei ; Xie, Xin ; Zhao, Shenglong ; Chen, Lu ; Zhao, Zhen ; Liu, Jingrui ; Zheng, Yuanyuan ; Hu, Honghai ; Lu, Yifan ; Zhai, Yanhong ; Jia, Zhaoxia ; Dong, Ying

AbstractBackground: Preeclampsia is a common obstetric multisystem disorder causing maternal and fetal morbidity and mortality; it’s been shown that the prediction improves preeclampsia outcomes in pregnancy. However, the current serum biomarkers had low clinical application values and still lack validation studies. Here we aimed to evaluate the preeclampsia prediction values of a series of serum biomarkers in Chinese pregnant women of > 20 weeks of gestation. Methods: Singleton pregnant women with preeclampsia-related clinical and/or laboratory presentations were recruited and had blood drawn at their first visits. The prospective cohort was further divided into preeclampsia-positive and preeclampsia-negative groups based on the follow-up results. The following markers were tested using the collected serum samples: soluble fms-like tyrosine kinase-1 (sFlt-1); placental growth factor (PlGF); thrombomodulin (TM); tissue plasminogen activator inhibitor complex (tPAI-C); compliment factors C1q, B, and H; glycosylated fibronectin (GlyFn); pregnancy-associated plasma protein-A2 (PAPP-A2); blood urea nitrogen (BUN); creatinine (Cre); uric acid (UA); and cystatin C (Cysc). Results: A total of 196 women with suspected preeclampsia were recruited with follow-up medical records. Twenty-five percent (n=49) of the recruited subjects developed preeclampsia before delivery, and 75% remained preeclampsia-negative (n=147). The serum levels of sFlt-1, BUN, Cre, UA, Cysc and PAPP-A2 were significantly elevated, and the PlGF level was significantly decreased in the preeclampsia-positive patients. In the receiver operating characteristics (ROC) analyses, the area under the curves were listed in the order of decreasing values: 0.73 (UA), 0.67 (sFlt-1/PlGF), 0.66 (Cysc), 0.65 (GlyFn/PlGF), 0.64 (PAPP-A2/PlGF), 0.63 (BUN), 0.63 (Cre), and 0.60 (PAPP-A2). With the cut-off values obtained from the ROC analyses, the positive predictive values of these serum markers were between 33.1% and 58.5%, and the negative predictive values were between 80.9% and 89.5%. Conclusions: Although several serum markers were found to be significantly changed with current prospective cohort, their limited predictive values in preeclampsia development posed potential barrier in clinical implementation. Further studies with larger cohort are warranted to further reveal the clinical utilities of the serum markers in preeclampsia prediction.

项与广州市康润生物科技有限公司相关的新闻（医药）

2022-09-20

·国家药品监督管理局政务服务门户

2022年09月20日医疗器械批准证明文件（准产）待领取信息发布

序号受理号产品名称申请人注册证编号批准日期备注1CQY2100055一次性使用延长管扬州莱斯特科技有限公司国械注准20163141484 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件2CQY2100916Nd:YAG激光皮肤治疗仪北京新科以仁科技发展有限公司国械注准20173010975 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件3CQY2100954髋关节假体武汉迈瑞科技有限公司国械注准20143132298 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件4CQY2101016骨接合植入物金属直型接骨板无锡市闻泰百得医疗器械有限公司国械注准20173130579 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件5CQY2101034光面骨水泥柄武汉迈瑞科技有限公司国械注准20143132271 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件6CQY2200417一次性使用血浆分离器陕西正源科技发展有限责任公司国械注准20173104313 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件7CQY2200569一次性使用冠状动脉球囊扩张导管业聚医疗器械（深圳）有限公司国械注准20173033337 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件8CQY2200585多层色树脂牙安阳市鹰牌齿科材料有限公司国械注准20183171626 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件9CQY2200594高频内窥镜手术器械杭州欧创医疗器械有限公司国械注准20183010128 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件10CQY2200599锁定金属接骨板系统创生医疗器械（中国）有限公司国械注准20183130490 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件11CQY2200612一次性使用胸穿包江苏省华星医疗器械实业有限公司国械注准20183141669 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件12CSY2200247乙型肝炎病毒e抗体校准品深圳迈瑞生物医疗电子股份有限公司国械注准20193401552 2022-09-15 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件13CSY2200250沙门氏菌及志贺氏菌核酸联合检测试剂盒（荧光PCR法）上海之江生物科技股份有限公司国械注准20183401701 2022-09-19 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件14CSY2200253乙型肝炎病毒表面抗体（Anti-HBs）测定试剂盒（化学发光免疫分析法）深圳迈瑞生物医疗电子股份有限公司国械注准20193401565 2022-09-14 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件15CSY2200256单纯疱疹病毒Ⅱ型IgM抗体检测试剂盒（磁微粒化学发光法）北京贝尔生物工程股份有限公司国械注准20183400368 2022-09-14 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件16CSY2200257抗c（IgM）血型定型试剂（单克隆抗体）长春博德生物技术有限责任公司国械注准20183401026 2022-09-14 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件17CSY2200263乙型肝炎病毒前S1抗原检测试剂盒（化学发光免疫分析法）复星诊断科技（上海）有限公司国械注准20173401246 2022-09-16 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件18CSY2200264沙眼衣原体（CT）核酸测定试剂盒（荧光PCR法）上海之江生物科技股份有限公司国械注准20183401707 2022-09-14 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件19CSY2200269可卡因检测试剂盒（胶体金法）上海八通生物科技股份有限公司国械注准20183401598 2022-09-19 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件20CSY2200270二亚甲基双氧安非他明检测试剂盒（胶体金法）上海八通生物科技股份有限公司国械注准20183401601 2022-09-19 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件21CSY2200271肠道病毒71型、柯萨奇病毒A16型和肠道病毒通用型核酸检测试剂盒（PCR-荧光探针法）北京万泰生物药业股份有限公司国械注准20183400236 2022-09-15 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件22CSY2200273单纯疱疹病毒Ⅰ型IgM抗体检测试剂盒（磁微粒化学发光法）北京贝尔生物工程股份有限公司国械注准20183400372 2022-09-15 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件23CSY2200274吗啡/甲基安非他明唾液检测试剂盒（胶体金法）上海八通生物科技股份有限公司国械注准20183401603 2022-09-15 在领取新的医疗器械注册证书时，均应提交原医疗器械证书原件24CQZ2101008优美莫司涂层冠状动脉球囊扩张导管山东吉威医疗制品有限公司国械注准20223031247 2022-09-19 /25CSZ2100084新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒（化学发光法）广州市康润生物科技有限公司国械注准20223401239 2022-09-16 /26CSZ2100282新型冠状病毒（2019-nCoV）核酸检测试剂盒（荧光PCR法）深圳泰乐德医疗有限公司国械注准20223401240 2022-09-16 /

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