For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only
To ramp up large-scale, community-based COVID-19 testing, BGI and MGI have teamed up to provide a one-stop, total lab solution as a result of the Emergency Use Authorization (EUA) amendment for BGI’s Real-Time Fluorescent RT-PCR Kit for SARS-CoV-2 Detection issued by the U.S. Food and Drug Administration.
The amendment increases the accessibility of SARS-CoV-2 test kits manufactured by BGI, adding more real-time PCR system models for use in COVID-19 testing. Hospitals and reference laboratories can now run the test on one of these real-time PCR systems:
The expanded EUA label also authorizes the optional use of MGISP-960RS automated sample preparation system (software v1.2) in addition to either using MGIEasy Nucleic Acid Extraction Kit (MGI) or QIAamp Virus RNA Mini Kit (Qiagen) for viral RNA extraction. The automation system significantly improves testing throughput and reproducibility. Inclusion of MGI’s viral RNA extraction kit, which is currently in abundant supply in the U.S, also addresses a severe sample preparation bottleneck for widespread testing.
The integrated workflow offered in this total lab solution replicates the global footprints of BGI’s Fire Eye Laboratories. This Fire Eye Laboratory model was initially demonstrated in Wuhan, China to perform up to 10,000 tests a day and is now adopted by more than 60 laboratories around the world.
Giving users the confidence and peace of mind for reliable SARS-CoV-2 testing and final test results, all key components of the total lab solution are manufactured in ISO 13485 compliant facilities.