造父变星获得FDA的SARS-CoV-2快速检测紧急使用授权
首个快速，即时，近乎患者的分子检测技术，用于检测引起COVID-19的病毒
加利福尼亚州桑尼维尔，2020年3月21日
/ PRNewswire /-
Cepheid今天宣布已获得美国食品药品管理局（FDA）的紧急使用授权（EUA）
Xpert®Xpress SARS-CoV-2的快速诊断方法，用于定性检测SARS-CoV-2（一种引起COVID-19的病毒）。
该测试旨在在Cepheid全球23,000多个自动化GeneXpert®系统中的任何一个上运行，
检测时间约为45分钟。
2020年3月21日
Coronavirus: FDA Approves Point-Of-Care Diagnostic Test
Cepheid said the test kits will be available by the end of the month.
Until now,
to get test result,
a health care worker would take a swab from the back of a person’s nose, and
send it off to a public health, commercial or hospital lab, or to a lab at the Centers for Disease Control and Prevention in Atlanta.
The process can take days.
The newly approved test kit
still involves taking a nasal swab, but the test can be done in a doctor’s office or clinic with a detection time of approximately 45 minutes,
according to Cepheid.
Coronavirus Live Updates : NPR
FDA approves coronavirus test that can diagnose COVID-19 in 45 minutes
The US FDA on Saturday approved a new rapid coronavirus test by California-based Cepheid.
The test can detect the novel coronavirus within 45 minutes, and can be processed by providers without training on one of the company’s 5,000 machines across the country.
On March 13, the FDA also gave emergency clearance for a test by Roche, which can diagnose COVID-19 in about three hours. Previously, patients have had to wait days for a diagnosis.
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