Shenzhen's BGI Genomics (SHZ: 300676) reported the US issued an Emergency Use Authorization for its RT-PCR kit for detecting SARS-CoV-2. The company says its test kit provides qualitative detection of SARS-CoV-2 in bronchoalveolar lavage fluid (BALF) and throat swabs. Results are available within three hours, the company said. The test was approved for China use on January 26, followed by CE-IVD marking for European use on March 2. Currently, BGI can manufacture 600,000 reactions per day and is scaling up to meet global demand.

As of March 22, BGI has produced a total of 4.7 million tests. The company has performed over 500,000 SARS-CoV-2 tests in its own central laboratories in China and is distributing its SARS-CoV-2 detection kits to more than 70 countries and regions around the world.

The company has donated over 130,000 tests since the beginning of the outbreak to regions and countries most in need of testing.

The BGI test offers high sensitivity (limit of detection at 100 copies/mL in BALF and 150 copies/mL in throat swabs) along with high specificity (no cross-reactivity with 54 human respiratory pathogens).

"The authorization of our diagnostic test for COVID-19 in the US will provide high-quality, high-volume testing capabilities to the US, and enable medical professionals to respond quickly to diagnose patients, preventing further spread of infection," said Ye Yin, CEO of BGI Genomics. "As one of the first responders to the outbreak in China, we quickly scaled up our production and have deployed large numbers of kits for testing in China and globally in countries where our test kit has been approved. We are committed in bringing rapid, accurate testing capabilities on a massive scale to bolster detection efforts throughout the United States and globally in order to fight the spread of this disease."

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