《COVID-19檢測》美國製造即刻保護! FDA核准(EUA)第一個在家病毒檢測-Lucira Health 簡單鼻拭子結果只需30分鐘
11/18日美國FDA通過了位於加利福尼亞Lucira Health公司的在家檢測產品的緊急使用權EUA，Lucira LAMP測試與PCR的測試陽性相比有94％的準確，它還正確地識別98％的健康未感染者。
產品簡單使用: 一次性檢測套件、14歲和以上人群可以自行在家收集鼻拭子，30分鐘就知道結果、美國製造
FDA裝置與放射健康中心的負責人Jeff Shuren在一份聲明中說：今天授權進行完整的在家測試是FDA對全國Covid-19做出回應的重要一步。現在更多美國人將能夠根據其結果立即採取行動，以保護自己和周圍的人。
Lucira COVID-19 Test Kit FDA EUA Letter
Device: Lucira COVID-19 All-In-One Test Kit
Company: Lucira Health, Inc.
Indication: Intended to detect the novel coronavirus SARS-CoV-2 that causes
COVID-19. This test is for prescription home use with selfcollected nasal swab specimens in individuals aged 14 and olderwho are suspected of COVID-19 by their healthcare provider.
This test is also authorized for use at the point of care (POC), inpatient care settings operating under a CLIA Certificate of Waiver,Certificate of Compliance, or Certificate of Accreditation, withself-collected nasal swab specimens in individuals aged 14 andolder, and in individuals aged 13 and under when the specimen is
collected by a healthcare provider at the POC.
This test utilizes a molecular amplification technology for thedetection of SARS-CoV-2 RNA in individuals with known orsuspected COVID-19.
