COVID-19:Cepheid、SARS-CoV-2検査キット:FDAの緊急使用許可を取得(動画):
Cepheid Receives Emergency Use Authorization from FDA for Rapid SARS-CoV-2 Test:
造父变星获得FDA的SARS-CoV-2快速检测紧急使用授权
カリフォルニア州サニーベール、2020年3月21日
/ PRNewswire /-
Cepheid:
Cepheidは本日、米国食品医薬品局(FDA)から、SARS-CoV-2検査キットの緊急使用許可(EUA)を取得したと発表しました
Xpert®Xpress :
COVID-19を引き起こすSARS-CoV-2ウイルスを、検出するための高速分子診断テストです。
GeneXpert®システム:
このテストは、CepheidのGeneXpert®システムで動作します。
検出時間は約45分とのこと。
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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