BGI gets emergency authorization for RT-PCR coronavirus test

2020 03 20 22 46 8645 Virus Coronavirus Cdc 400

BGI has received an emergency use authorization (EUA) from the U.S. Food and Drug Administration for a real-time fluorescent reverse transcription polymerase chain reaction (RT-PCR) test for SARS-CoV-2, which causes the respiratory disease COVID-19.

The test, which is intended for the qualitative detection of SARS-CoV-2 in bronchoalveolar lavage fluid (BALF) and throat swabs, can return results within three hours, according to the company. BGI hopes the kit, which it said was one of the first used in China and has been used more than 1 million times, will accelerate clinical testing in the U.S.
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