BGI Genomics Co. Ltd. (“BGI”)
Product Description:
BGI’s Real-Time Fluorescent RT-PCR kit for detecting the 2019 novel coronavirus (SARS-CoV-2) is a qualitative in
vitro nucleic acid amplification assay designed for the ultra-sensitive and rapid investigation of SARS-CoV-2. The kit
has been awarded CE IVD marking, and now is commercially available as a certified IVD in markets that accept CE
marking as valid regulatory approval.
On April 24, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) amendment for BGI’s Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2. The amendment expands the previously issued EUA label to further include the use of automated sample preparation system, additional viral RNA extraction kit and PCR systems for testing a broader range of clinical samples. Specifically, viral RNA extraction can be processed by the kits manufactured by MGI (a subsidiary of BGI Group) or Qiagen. In addition, the highly sensitive SARS-CoV-2 detection test can return results within 4 hours for 192 samples collected from throat (oropharyngeal) swabs, nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes, nasal aspirates and bronchoalveolar lavage fluid (BALF) using the MGI automated sample preparation system. Hospitals and reference laboratories can run the test on Roche LightCycler 480 Instrument as well as Applied Biosystems 7500 Fast, 7500 and QuantStudio 5 Real-Time PCR Systems.
Features:
• Samples to results within 3 hours
• Taqman Reverse Transcription PCR
• ORF1ab gene as domain target
• Human ß–actin as internal control
• Manufacturing in ISO 13485 compliant and
high-volume production facility
• Stringent QC with positive and blank controls
Benefits:
• Highly sensitive - Superior limit of detection
• Highly specific - No cross-reactivity with other major human-related pathogens
• Fast - One-step duplex reaction with single target and internal control
• Easy to use - Pre-mixed primers, probes and enzymes
• Easy to interpret results - Analysis of one target with well defined controls
Specifications:
• 50 reactions per kit
• Samples collected from throat swab or bronchoalveolar lavage fluid (BALF)
• Compatible with many major real-time PCR systems
• Limit of detection: 100 copies/mL
• Reagents stable under dark for 5 days at 2-8°C or 6 months at -18°C
• No cross-reactivity with human genome or 54 other human related pathogens
Key Components:
