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冷冻鼻咽拭子 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). main products Amia with Sharesource for Renal Care Spectrum IQ Infusion System for Hospital Care Numeta G13E for Nutritional Care HDx Enabled by Theranova for Renal Care Floseal Hemostatic Matrix for Surgical Care Prismaflex System for Critical Care PrisMax System for Critical Care Oxiris Blood Purification Set for Critical Care https://www.bbbtech.com
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)。
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