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US Approves Fosun Pharma's COVID-19 Test Kit under Emergency Rules

publication date: Apr 20, 2020
 | 
author/source: Richard Daverman, PhD

The US FDA has granted emergency use authorization (EUA) for a COVID-19 RT-PCR detection kit developed by Shanghai Fosun Pharma (SHA: 600196; HK: 02196). The test provides qualitative detection of novel coronavirus RNA by targeting the specific ORF1ab, N and E genes. It can complete the detection of 96 samples within two hours by using fast automatic nucleic acid extraction instruments and reagents. One month ago, the testing kit, which was developed by Fosun's Long March subsidiary, was certified by China's NMPA and the European Union.

Because the test is automated, it offers lower risk of operator infection, a reduced probability of cross contamination in the clinical laboratory and improved detection efficiency, Fosun said.

Fosun Pharma has been engaged in the business of PCR hepatitis B virus diagnostic reagents since its establishment in 1994. Currently, its offers medical diagnosis products that include biochemical diagnosis, immune diagnosis, molecular diagnosis and microbial diagnosis, POCT and mass spectrometry, and third-party detection service products, with a nationwide marketing network in China.

See our other articles on Fosun Pharma.

Disclosure: none.



 

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