September 4, 2020
Last month, Sweden’s Public Health Agency announced that two laboratories discovered an RT- PCR kit for SARS-CoV-2 detection had returned around 3,700 false-positive results. The agency expressed concerns that the kits from BGI Genomics could not distinguish between very low levels of the virus and a negative result.
Lars Engstrand, director and professor at Karolinska Institutet/Science for Life Laboratory in Sweden, performed an analysis of the BGI RT- PCR kit for SARS-CoV-2. He explained in an interview that the rate of positive detection can be linked to test sensitivity. Professor Engstrand also assured the public that “this test has been used in many, many countries. And in our hands today, it works perfectly fine. I am not worried today. We can validate with other kits and other labs and we have 100 percent agreement between the answers.”
In a response to Sweden’s concern, BGI Genomics stated that the “high positive rate” was due to the amount of virus inside asymptomatic patients, and different countries and regions define asymptomatic patients differently. Different strategies have been implemented around the world. As a country with high population density, China prefers to implement stringent rules, conduct thorough tests, and set high sensitivity to avoid any blind spots and possible infections. Keep reading
On May 11, 2020, the plane carrying 11 tonnes of medical materials donated by the Chinese government, private Chinese organisations and individuals to support Papua New Guinea’s COVID-19 response, touched down in Port Moresby. Among the equipment, are 2,000 COVID-19 RT-PCR test kits supplied by BGI Genomics, in a joint effort with Mammoth Foundation and Phoenix Television as part of their COVID-19 RT-PCR Test Kit global donation initiative.
The donation ceremony was attended by the Chinese Ambassador to PNG Xue Bing and PNG Foreign Minister Patrick Pruaitch, PNG Health Minister Jelta Wong and other PNG government officials. Pruaitch expressed gratitude for the assistance on behalf of the PNG government and the people.
Photo: Donation ceremony in Port Moresby, Papua New Guinea attended by Chinese Ambassador to PNG Xue Bing (third from right) and PNG Foreign Minister Patrick Pruaitch (fourth from right), and other officials. Source: Xinhua News
The Mammoth Foundation is a non-profit philanthropic organisation based in Shenzhen, China. Sponsored by BGI Group, Vanke Group and Green Pine Capital Partners, the foundation has been actively participating in the international arena fighting COVID-19, by providing aid and resources to a number of countries and regions to boost their testing capability.
On 14 May, a special ceremony was held at BGI Australia's Brisbane office to recognise BGI's endeavours in the STAT project, which successfully completed the installation of 11 COVID-19 testing labs across Australia in a record time, in collaboration with Minderoo Foundation.
The BGI team based in Australia and China worked extremely hard to deliver a high-quality project utilising the acclaimed BGI "Huo-Yan" COVID-19 laboratory solution. Among them are several BGI staff members that flew in urgently from the the Chinese headquarter to contribute their expertise in the operation. We are proud to recognise their massive contributions and the BGI spirit that they have unwaveringly demonstrated throughout the project.
At BGI, we believe that rapid sharing of high-quality genome data of SARS-CoV-2 virus has a high value for public health emergency response. BGI calls upon the global research community to join the Global Initiative on Open-source Genomics for SARS-CoV-2 (GIOG-S).
The GIOG-S encourages partners from any nation in an effort to move beyond borders, to establish an all-inclusive effort aimed at understanding the SARS-CoV-2 virus and finding effective prevention and control techniques. BGI makes its platforms for multiplex PCR sequencing and ultra-deep metagenomics sequencing available to global research teams within GIOG-S.
On 29 April 2020, Federal Minister for Health, the Hon Greg Hunt MP, and Minderoo Foundation Chairman, Dr Andrew Forrest AO, have announced the ground-breaking partnership formed between the Australian Federal Government and Minderoo Foundation to secure an abundance of COVID-19 testing kits and other equipment, in a mission to eliminate COVID-19 in Australia.
BGI Group has joined the initiative named “Security Through Accelerated Testing” (STAT). The STAT initiative aims to substantially expand Australia’s testing capacity by an additional 54,000 tests per day, a more than three-fold increase from the current daily COVID-19 testing capacity across Australia.
With urgent TGA approvals in place, critical BGI lab equipment has been transported from China on Minderoo’s 10 chartered flights, along with a team of experienced BGI technical specialists and engineers who hail from various parts of China to provide training and technical support to the local Australian counterparts. In an effort to bolster Australia’s COVID-19 screening and surveillance capability as it moves towards a new phase of a broader testing regime, BGI has committed to supplying a massive amount of RT-qPCR test kits to ensure adequate access to tests for nearly half of the Australian population. Read More
BGI believes its COVID-19 laboratory solution is key to the successful implementation of the population test initiative. Initially designed to tackle the COVID-19 outbreak in China, BGI devised the Huo-Yan (“Fire-Eye”) laboratory solution comprised of the real-time SARS-CoV-2 RT-qPCR test kit, high-throughput automated sample preparation system MGISP-960, and the sample extraction kit. This solution has proven effective in contributing to China’s speedy recovery from the COVID-19 outbreak. Other countries have also set up Huo-Yan labs to assist with large-scale screening and diagnoses.
Brisbane, Australia – BGI Health (AU) Company Pty Ltd (BGI Health), a subsidiary of BGI Group (BGI), is pleased to announce that its Real-Time SARS-CoV-2 RT-PCR test has been entered successfully in the Australian Register of Therapeutic Goods (ARTG) <ARTG ID 334043> on April 11 for supply to the local Australian market.
BGI’s COVID-19 RT-PCR test has received emergency approval from China’s National Medical Products Administration (NMPA) on January 26, followed by the European CE-IVD marking on February 24, the U.S. FDA-issued Emergency Use Authorization (EUA) on March 26 as well as Japan’s marketing approval on March 27.
As of March 20, 2020, WHO reported 244,146 confirmed cases of COVID-19 globally, resulting in 10,023 fatalities. BGI rose up to the challenge and has been playing an active role in leading this fight since the wake of the crisis. BGI was appointed the third-party detection agency by Chinese National Health and Medical Commission shortly after the outbreak, while its COVID-19 diagnostic and sequencing kits have achieved many milestones during this journey:
In February 2020, BGI established its first Huo-Yan laboratory in Wuhan within five days to scale up the daily testing capacity. This was followed by more Huo-Yan labs in a total of 12 cities across China. Equipped with the BGI COVID-19 RT-qPCR test kits and MGI SP-960 sample preparation systems, the maximum daily throughput of these labs can reach 80,000 tests per day. The Huo-Yan model is an effective measure to enable mass diagnoses and identification of suspected cases, release of recovered patients, and screening of close contacts and high-risk groups. This has been proven by China's epidemic prevention and control practices. The Huo-Yan laboratories are now part of BGI’s anti-pandemic pathogen detection solution available to customers worldwide.
BGI brings to its Australian partners and customers a rapid and complete total detection solution of COVID-19, the key components of which are the Real-Time Fluorescent RT-PCR Kit and Automated One-Stop Nucleic Acid Extraction on High-Throughput Sample Preparation System MGISP-960.
· CE-IVD & NMPA certification (granted), FDA EUA and TGA certification (pending).
· One-step reaction. Results issued under three hours.
· High sensitivity and specificity: LOD of 100 copies/ml, target gene: orf1ab, no cross reactivity with SARS and other types of coronavirus.
· An internal control is set to monitor the laboratory procedures including nucleic acid extraction, revert transcription and amplification in each reaction.
· Validated to run on ABI7500 or SLAN-96P PCR system while compatible with any real-time PCR instruments with the FAM channel and VIC/HEX channel.
· A total of 2.18 million tests have been produced as of March 16 and distributed to over 60 countries.
· CE-IVD and NMPA certified.
· Performs 96 samples under 60 minutes or 192 samples under 80 minutes.
· MGIEasy magnetic beads virus DNA/RNA extraction kit or compatible with third-party magnetic bead RNA extraction kit.
· Sample types: Respiratory tract samples such as throat swabs, alveolar lavage fluid, sputum; Serum, plasma and other blood samples; Virus broth and other specimen types.
· SP-960 can be used as an open or closed platform for: Nucleic Acid extraction, liquid handling, automation of NGS library prep, PCR setup and running endpoint PCR, etc.