For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only
Total Lab Solution
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:
● Applied Biosystems 7500, Software v2.0.5
● Applied Biosystems 7500 Fast, Software v2.0.6
● Applied Biosystems QuantStudio 5, 96-Well, Software v1.5.1
● Roche LightCycler 480, 96-Well, Software v1.5.0
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.
Features and Benefits
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.
1) Superior Performance
● RT-PCR assay detects as little as 100 viral copies/mL from bronchoalveolar lavage fluid samples
● Thoroughly tested automated RNA extraction protocol for high throughput operation
● Fine pipetting precision enabled by automation system
● Reduction in user operating errors resulting in higher reproducibility
2) Highly Efficient
● Fast TAT: sample to result in 4 hours
● High throughput: MGISP-960 processes 192 samples in 80 minutes
● Easy operations: one person can operate three automation systems simultaneously
● Economic: truly walk-away system and sample processing in batches
● Efficient RNA extraction through optimized chemistry
3) Broad Compatibility
● Compatible with most real-time PCR instruments commonly found in labs
● Viral RNA extracted from samples collected by throat swab, nasopharyngeal swab, and more
● Applicable with viral RNA extraction kits manufactured by MGI or Qiagen
4) Integrated Process
● One-stop shop for the majority of components required in an end-to-end workflow
● Pre-mixed RT-PCR reaction reagents, extraction buffers and magnetic beads included
● Sample processing designed with safety in mind with UV lamp, laminar flow hood (ISO5) and protective door
Read the flyer for our product highlights.