Product Description

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 an 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. Also, the highly sensitive SARS-CoV-2 detection test can return results within 4 hours for 192 samples collected from the 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

● Taqman Reverse Transcription PCR

● ORF1ab gene as domain target

● Human β–actin as an internal control

● Manufacturing in ISO 13485 compliant and high-volume production facility

● Stringent QC with positive and no template controls

Benefits 

● Highly sensitive – Detect as low as 100 viral copies/mL for BALF samples

● Highly specific – No cross-reactivity with 54 human respiratory pathogens

● High-throughput – Ramp up labs for large-scale, community-based testing

● Fast TAT – Sample to result in 4 hours with automated sample preparation system

● Ease of use – All-inclusive with pre-mixed reaction reagents

● Easy interpretation – Analysis of one target with well-defined controls