The most accurate COVID-19 nucleic acid detection kit (Fluorescent RT-PCR method), with CE, FDA(TUA) certification

Product Details

The 2019-nCoV nucleic acid detection kit (fluorescence RT-PCR method) has a daily production

capacity of 2 million copies.

BGI's new coronavirus 2019-nCoV nucleic acid detection kit (fluorescence PCR method) has

obtainedthe medical device registration certificate issued by the National Medical Products

Administration. It isthe first batch of new coronavirus detection products approved in China

for the Chinese governmentThe main supplier of new coronavirus detection kits to fight the

epidemic. At the same time, a largenumber of 2019-nCoV nucleic acid test kits were donated to

people around the world to fight against the new coronavirus epidemic. The new coronavirus

2019-nCoV nucleic acid detection kit (fluorescencePCR method) has also completed the EU CE

certification, obtained the EU free sales certificate, and hasthe access conditions for the

EU market. It is also the first Chinese company to obtain the EUA issuedby the US FDA (

Emergency use authorization) enterprise.

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 amplifification 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 certifified IVD in markets that accept CE marking as valid regulatory approval.

Features :

• 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

Benefifits :

• Highly sensitive – Superior limit of detection

• Highly specifific – 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 defifined controls

Specififications :

• 50 reactions per kit

• Samples collected from throat swab or bronchoalveolar lavage flfluid (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

US FDA (EUA) inquiry website:

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas