FDA Grants EUA To PerkinElmer's SARS-CoV-2 RT-PCR Assay For Asymptomatic Testing - Quick Facts

FDA授予Perkinelmer's新型冠状病毒RT-PCR无症状检测方法EUA

2021-01-24 10:53:13 RTTNews

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PerkinElmer, Inc. announced Thursday that its PerkinElmer New Coronavirus Nucleic Acid Detection Kit received Emergency Use Authorization from the U.S. Food and Drug Administration to test individuals without symptoms or other reasons to suspect COVID-19 infection. For asymptomatic carriers, diagnostic testing is essential to identify infected individuals, and thereby provides a better chance of getting infectious individuals into isolation to avoid spreading the disease further. Based on comparative data released by the FDA, the PerkinElmer test kit has the lowest Limit of Detection (LoD) among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay. PerkinElmer's SARS-CoV-2 RT-PCR assay originally obtained FDA EUA in the spring of 2020. The Company's comprehensive SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing. For comments and feedback contact: editorial@rttnews.com
PerkinElmer,Inc.周四宣布,其PerkinElmer新型冠状病毒核酸检测试剂盒获得美国食品和药物管理局的紧急使用授权,可对没有症状或其他原因怀疑感染COVID-19的个人进行检测。 对于无症状的带菌者,诊断性测试对于识别受感染的个体至关重要,从而提供更好的机会将受感染的个体隔离,以避免疾病进一步传播。 根据FDA公布的比较数据,PerkinElmer检测试剂盒在已报道的已获授权的COVID-19分子诊断试验中具有最低的检测限(LoD),被认为是最敏感的检测方法。Perkinelmer's新型冠状病毒RT-PCR检测最初于2020年春季获得FDA EUA。 该公司全面的新型冠状病毒产品涵盖高通量RNA提取,RT-PCR,自动化,ELISA,化学发光,时间分辨荧光和基于横向流动的血清学检测。 如需评论和反馈,请联系:editorial@rttnews.com

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