bbbtech产品代理
bbbtech产品代理
使用2020年9月至2021年4月期间从美国多个地点收集的冷冻鼻咽拭子标本评估MARK-B™COVID-19 Ag的临床表现，并对照商业RT-PCR分子分析作为参考方法。为了纳入研究，患者必须在症状出现8天内出现COVID-19样症状。共选择样本207份，其中阳性样本72份，阴性样本135份。MARK-B™COVID-19 Ag检测由受过最低程度培训的操作人员进行，这些操作人员是目标用户的代表。MARK-B™COVID-19 Ag的临床表现的敏感性为93%(67/72)，特异性为100%(135/135)。
MARK-B™ COVID-19
MARK-B™ platform
neurogear®
elemark®
Frozen Nasopharyngeal Swab
The clinical performance of MARK-B™ COVID-19 Ag was evaluated with frozen nasopharyngeal swab specimens, which have been collected from multiple sites in the United States between September 2020 and April 2021, against a commercial RT-PCR molecular assay as a reference method. To be enrolled in the study, patients had to be presenting at the sites with COVID-19 like symptoms within 8 days of symptom onset. the RT-PCR assay and a total of 207 samples including 72 positive and 135 negative specimens were selected for the study. MARK-B™ COVID-19 Ag test was performed by minimally trained operators who are representative of the intended users. The clinical performance of MARK-B™ COVID-19 Ag was concluded as a sensitivity of 93% (67/72) and a specificity of 100% (135/135).
