属性Self-Test(自用试剂),和 Regulation (EU) 2017/746 on in vitro diagnostic medical devices下直辖管理,高危级别Class D医药机械属类CE必需准证,也代表了其卓越质量在非专业用人士使用下不易出错,符合欧盟高标准,接近分子测试PCR结果,高达>=90%sensitivity的灵敏性和>=97%specificity特定性。目前...
SIEMENS Clinitest Rapid Covid-19 Antigen Self-Test Instructions 网页链接 包装上写了是FDA的 EUA 包装盒在12月15日已经确定 Clinitest 新冠抗原试剂盒获得FDA的EUA正式批复是12月29日 五只装包装盒GCCOV-502a-H5US(11556712) 一只装包装盒GCCOV-502a-H1US(11561587) 下图是非美国的5只装 试剂盒(美国版类似...
Rapid antigen assays (RAD) based on lateral flow immunochromatography (LFIC) technology have emerged as a valuable tool for the control of COVID-19 pandemic. Manufacturer﹊ndependent, real﹚orld evaluation of these assays is crucial given the considerable heterogeneity reported in their clinical and...