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