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.
• Samples to results within 3 hours
• Taqman Reverse Transcription PCR
• ORF1ab gene as domain target
• Human β–actin as internal control
• Manufacturing in ISO 13485 compliant and high-volume production facility
• Stringent QC with positive and blank controls
• 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
• Stringent QC with positive and blank controls
• 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