FDA Accelerates Efforts To Issue EUA For More COVID-19 Home Tests

FDA加快为更多新冠肺炎家庭检测发放EUA

2021-03-13 00:00:17 RTTNews

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The U.S. Food and Drug Administration is hastening its efforts to make available more at-home testing options in response to the ongoing COVID-19 pandemic. All At-Home Covid-19 Tests being used now are authorized only for emergency use, and not cleared or fully approved by the FDA. The recent granting of EUA for the Quidel Corp.'s QuickVue At-Home COVID-19 Test is one example of the FDA working with test developers to bring important diagnostics to the public. It provides qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2. The QuickVue At-Home COVID-19 Test is another antigen test where individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. The easy-to-use at-home test provides results in ten minutes with a doctor's prescription. The test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. It is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. Quidel claimed that The QuickVue At-Home COVID-19 Test shows excellent performance, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time. The at-home test employs the same Quidel lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received EUA from the FDA for use in professional settings in December 2020. The EUA for the QuickVue At-Home COVID-19 Test was expedited after Quidel's contract with the National Institutes of Health's Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the test. Quidel's new manufacturing facility will begin operations in the second half of 2021, initially with a target to produce more than 50 million QuickVue rapid antigen tests per month, or 600 million tests per year at full capacity. Quidel has also provided rapid COVID-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia tests last year. Quidel's QuickVue brand was launched in 1986 with visually read rapid diagnostics focusing on women's health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test approved by the FDA for professional use. QuickVue was also the first flu test cleared by the FDA. For comments and feedback contact: editorial@rttnews.com
美国食品和药物管理局(U.S.Food and Drug Administration)正加紧努力,为应对持续的新冠肺炎疫情提供更多的居家检测选择。目前正在使用的所有家庭新冠病毒检测都只被授权用于紧急情况下的使用,并没有得到FDA的批准或完全批准。 最近为Quidel Corp.的QuickVue家庭COVID-19测试授予EUA是FDA与测试开发商合作将重要诊断结果带给公众的一个例子。提供了来自新型冠状病毒的核衣壳蛋白抗原的定性检测。 QuickVue居家COVID-19检测是另一种抗原检测,个人可以在家中快速收集和检测样本,而不需要将样本送到实验室进行分析。简单易用的在家测试提供了十分钟的结果与医生的处方。 本试验允许在家庭处方中使用14岁及以上的个体自采前鼻(鼻孔)拭子,或8岁及以上的个体自采成人拭子。医疗服务提供商在出现症状的头6天内为疑似COVID-19的个人授权使用。 奎德尔声称,QuickVue居家新冠检测显示出卓越的性能,阳性结果与PCR符合率为84.8%,阴性结果符合率为99.1%。 该上门测试采用了医疗保健专业人员数十年来使用的相同Quidel横向流动技术,并采用了2020年12月从FDA获得EUA用于专业环境的相同SARS CoV-2快速抗原测试条和试剂溶液。 QuickVue在家COVID-19测试的EUA在Quidel与美国国家卫生研究院的快速加速诊断倡议的合同于2020年末扩大到包括该测试后加快。 Quidel的新制造设施将于2021年下半年开始运营,最初的目标是每月生产超过5000万份QuickVue快速抗原检测,或满负荷生产每年6亿份检测。 在整个疫情期间,Quidel还通过医生和卫生保健提供商提供快速新冠检测,去年生产和运送了数百万次索非亚检测。 Quidel的QuickVue品牌于1986年推出,以可视化阅读快速诊断技术为核心,专注于妇女健康和呼吸道疾病。1999年,QuickVue A+B型流感是FDA批准用于专业用途的第一个可视化快速检测。QuickVue也是FDA批准的第一个流感检测。 如需评论和反馈,请联系:editorial@rttnews.com

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