NEW YORK – BGI said late on Friday that its Real-Time Fluorescent RT-PCR kit for detecting SARS-CoV-2 (also known as 2019-nCoV) has received CE-IVD marking and is now commercially available in markets recognizing the designation.
BGI's kit is a qualitative in vitro nucleic acid amplification assay that detects 2019-mCoV, the cause of COVID-19, using reverse transcriptase PCR from throat swab and bronchoalveolar lavage fluid samples.
The CE-IVD mark follows approval by China's National Medical Products Administration in late January of BGI's PCR kit and BGI subsidiary MGI's full sequencing platform and metagenomic sequencing assay for SARS-CoV-2 detection.
BGI said the PCR assay is already widely used in China for diagnosing suspected cases and determining whether recovered patients should be discharged. The Huo-Yan Laboratory in Wuhan, the emergency test laboratory run by BGI, is designed to handle 10,000 samples daily using the kits daily, the company said.