NEW GUIDELINES FOR COVID TESTING
A new ISO technical specification proposed by BGI, Chinese gene test company, will improve testing procedures and contribute to a safer world.
SHENZHEN, China, May 13, 2022 /PRNewswire/ -- The COVID pandemic first reared its head in 2019 and despite concerted efforts from authorities and the public, it's still with us. Dedicated standardizer and biology expert Dr. Ye Yin, CEO of BGI, Chinese gene test company, introduced more about the technical specification in an interview with ISO.
Recently published, ISO/TS 5798 provides recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
Most of us know that various types of COVID test are available, but the new technical specification uses nucleic acid testing. Can you tell us how that works?
Ye: The discovery of DNA in 1953 enabled a new era in molecular biology, moving pathogen research forward from the morphological level to the molecular level. Nucleic acid testing, which operates on this molecular level, has gradually become the mainstream of pathogen detection. That's partly because it can provide direct detection without prior isolation and culture of pathogens, making it convenient, fast and highly sensitive.
Such tests use a nucleic acid hybridization technique that is based on double-stranded complementary pairing of nucleic acids. Basically, technicians synthesize a single-stranded nucleic acid sequence complementary to the DNA or RNA of a specific pathogen as a probe. They would then label it using, for example, radioisotopes or enzymes, and subject it to hybridization with the nucleic acids of the pathogen to be tested. If a probe can be complementarily paired with the nucleic acid of the pathogen to be tested, it is possible to observe the signals of the markers, so that the species of the pathogen to be tested can be confirmed. The specificity and sensitivity of such tests are relatively high and are of crucial significance for the early diagnosis of infectious diseases.
How can a new technical specification for SARS-CoV2 testing help us to finally end the COVID pandemic?
Ye: COVID-19 has become the most widespread global pandemic in the past 100 years. It is also the first time that molecular biology genomics has been applied on a super-large scale in response to an emerging outbreak.
There are currently three methods for detecting SARS-CoV-2: nucleic acid tests, antigen tests, and antibody tests. The nucleic acid test is the 'gold standard' for pathogenic diagnosis, faster and more accurate than the other methods. But variations in procedures and materials used by laboratory personnel can contribute to variable quality test results.
The rapid global spread of COVID-19 meant that many testing reagents of varying quality emerged worldwide. Establishing clear quality assessment requirements for testing reagents was needed, together with guidance to enable accurate, early diagnosis and screening are essential to control the spread of the pandemic and treat patients in time. Clear guidance was urgently needed from ISO, which led to the development of ISO/TS 5798.
What are the main points covered by the new Technical Specification, and who is it aimed at?
Ye: ISO/TS 5798 mainly focuses on the use of nucleic acid amplification methods for diagnosis and screening of SARS-CoV-2 and proposes requirements and recommendations for the design, development, validation, verification, and implementation of testing methods.
It covers the steps of the overall process of pre-examination, examination and post-examination for the analysis of nucleic acid amplification method for detecting SARS-CoV-2, and specifies the methods and comprehensive assessment indicators, including accuracy, limit of detection, inclusivity, specificity, etc.
The new standardized guidelines fill a gap in the quality control of testing, and apply to medical laboratories, in vitro diagnostic developers and manufacturers, and institutions and organizations in support of research and diagnosis of SARS-CoV-2.
Why was a new testing standard needed? What's significant about ISO/TS 5798?
Ye: The new technical specification from ISO is the world's first guidelines for nucleic acid testing of SARS-CoV-2.
It provides important technical basis and support to global medical laboratories, in vitro diagnostic test reagent developers and manufacturers, and institutions and organizations for new coronavirus research. It supports the global response against the pandemic with science and technology and shares advanced technical achievements and successful experience of SARS-CoV-2 nucleic acid testing worldwide, which also helps establish reference values for the testing of other viruses and potential epidemics.
Are further COVID-related standards needed in order for us to end the pandemic?
Ye: The fight against COVID-19 involves nucleic acid testing and other activities such as infectious disease prevention and control, microbiological testing and public health emergencies response. I have been closely following the development of ISO standards related to COVID-19. For example, the ISO Technical Committee on tourism and related services published a publicly available specification that provides safer tourism services and products for tourists and residents.
Further standards related to COVID-19 are expected to be released in the future. These standards will jointly build a standard system for addressing COVID-19, guaranteeing the scientific approach, improving the quality of products and facilities for epidemic prevention and control, and contributing to the promotion and replication of excellent epidemic prevention experience. These ISO standards will help us take concerted action and win the global battle against COVID-19.
This article was written by Barnaby Lewis: https://www.iso.org/news/ref2798.html
SOURCE BGI Genomics
BGI Genomics, Chinese gene test company, showcases high-throughput COVID testing air lab at Dubai World Expo
BGI Genomics’ Huo-Yan Air Laboratory model was showcased at the China Pavilion of Dubai World Expo, from January 11 to 13.
With the continuing spread of COVID-19 worldwide, the Huo-Yan Air Laboratory, which can be set up anywhere in a very short amount of time, was created by BGI Genomics for dealing with the pandemic. The smart Air Lab can be easily stored, transported, and seamlessly integrated with existing facilities when set up. Furthermore, the design can be scaled to a national level, meeting the current challenge of a worldwide lack of COVID-19 detection facilities.
Chen Yue, Global Manager of Medicine at BGI Genomics, said, "This has provided BGI Genomics with a key opportunity go to the world stage. We develop products and solutions to deal with pandemic, and export China's technology, experience and standards in fighting epidemics worldwide, and empower global health care with engineered, standardized and regulated technology and services."
Since the outbreak of COVID-19, BGI Genomics has been working closely with Saudi Arabia's Ministry of Health, and established Saudi Huo-Yan Lab to combat the COVID-19 pandemic. The Saudi Ministry of Health highly evaluated the Lab.
Mohamed Osama from Egypt said, "This is the first time I have seen such a testing facility that can be set up quickly and without site restrictions. This 'mobile' laboratory makes up for the lack of testing capacity in the Middle East and contributes greatly to the prevention and control of epidemics in the region. I also hope that more countries around the world will learn about this cutting-edge technology and come together to fight the COVID-19 pandemic."
BGI Genomics provided a full set of nucleic acid detection solutions and a virus sequencing platform to Saudi health authorities, helping the country establish a monitoring capability for COVID's mutated strains. The Lab currently handles 50% of Saudi Arabia's countrywide testing needs, operates within the protocols of the most stringent turnaround time (TAT) standards, and has already completed the testing of over 16 million people.
The Huo-Yan Air Laboratory, jointly designed and developed by BGI Genomics, the College of Design and Innovation at Tongji University and Shanghai Etopia Building Technology, has been acclaimed by the world design community. The Air Lab has garnered the Red Dot Winner, the iF Design Award, IAI Best Architecture Award-Architecture Concept Design and the Contemporary Good Design Award, among other international design recognitions.
By June 2021, BGI Genomics has built more than 90 Huo-Yan Laboratories in 30 countries and regions worldwide, providing in the aggregate the results of up to one million COVID tests per day. BGI Genomics continues to export the Huo-Yan Lab solution worldwide, contributing to the battle against the further spread of the disease.
This year's Shenzhen Science and Technology Innovation Interactive Exhibition was set up as part of the "Guangdong Week" exhibit at the China Pavilion of Dubai World Expo. Themed "Communicating Ideas, Creating the Future", this Expo is the first World Expo held in the Middle East.
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BGI safeguards Ethiopia-China Route with airport COVID-19 testing lab
Fast and accurate testing labs built by BGI, Chinese gene test company, at international terminals offer a new solution, as airports continue to be a focal point against the global spread of COVID-19
SHENZHEN, China, Sept. 3, 2021 /PRNewswire/ -- BGI's COVID-19 testing lab has helped 5,500 Chinese travelers safely fly out of the Addis Ababa Bole International Airport, from April to August, 2021. In April, BGI set up the "Huo-Yan" laboratory, at the airport for passengers flying to China in cooperation with Ethiopia Airlines. Since then, the lab has contributed to around five consecutive months without a single flight suspension on the route.
The pre-flight testing procedures pioneered at the lab present an option for reducing the pressure of containment measures at destinations.
The lab provides quick, accurate nucleic acid polymerase chain reaction (PCR) testing and antibody testing services to passengers at the Airport. The lab can test up to 400 samples within three hours and 5,000 samples per day, reducing inconvenience for departing and transiting at the Airport.
The lab helps reduce imported cases. Passengers are required to quarantine first. They are not allowed to board until obtaining negative results for both a COVID-19 nucleic acid PCR test and an antibody test.
Since the start of operations at the lab, the number of outbound positive cases found on arrival has sharply decreased. To date, no flights have been suspended between Ethiopia and China, making this the only direct flight from the African continent to China that has been continuously operating during this period.
"From April 21 to August 31, the laboratory has provided testing services for more than 5,500 passengers on 19 flights to China," said Chen Songheng, the head of the "Huo-Yan" laboratory in Ethiopia.
BGI has built more than 30 "Huo-Yan" laboratories with partners in over 80 countries and regions. By providing one-platform solutions with accurate, efficient testing, the labs play a vital role in contributing to the global fight against the COVID-19 pandemic.
BGI leads innovative development in genomics and life sciences. Through its integrated model, it incorporates industry development, education and research in compliance with international bioethical protocols. It applies frontier multi-omics research findings to areas including medicine, healthcare and resource conservation, and provides cutting-edge proprietary life science instruments and devices, technical support and solutions to revolutionize the current healthcare system towards precision medicine and healthcare.
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BGI is granted patent in 16 countries for non-invasive prenatal genetic test technology
October 10, 2014, Shenzhen, China-- The European Patent Office has issued patent number EP2561103B1 for invention to BGI China for its independently researched non-invasive prenatal genetic test (NIPT) technology. This technology has been developed by BGI in connection with the provision of its market leading NIPT, the NIFTY® test. The patent is effective in 15 member countries including England, Belgium, Spain, Slovenia, Hungary, Sweden, Turkey, Switzerland, Italy, France, Denmark, Germany, Czech Republic, Poland and Romania.
This patent was granted by the European Patent Office. This is the first patent for non-invasive prenatal genetic testing technology approved by the Europe Patent Office to a mainland Chinese registered company.
Meanwhile, the State Intellectual Property Office of China also issued a Notice of Grant of Patent Right to BGI, meaning that this patent has been granted domestically as well as internationally.
This global recognition for BGI's technology comes after BGI became the first non-invasive prenatal test provider to receive approval from government level for a second generation gene sequencing diagnostic product when it obtained approval from the CFDA in July, 2014.
As of August, 2014, BGI Dx, a subsidiary unit of BGI, has provided non-invasive prenatal genetic testing services via its NIFTY® test to nearly 400,000 pregnant women worldwide.
More Information:
This patent relates to non-invasive testing technology of fetal genetic abnormality, that was researched and developed independently by BGI, through carrying out DNA sequencing in blood samples of pregnant women, to non-invasively detect for fetal genetic abnormality.
BGI's technology involves use of a core algorithm for determining GC content differences in chromosomes, improving accuracy of the result. This technology is used in the test screening for the three most common trisomy conditions present at birth (trisomy 21, 18 and 13) but also covers screening for sex chromosomal conditions XO, XXX, XXY, XYY and certain deletion syndromes, and is included as part of the NIFTY® offering at no additional charge.
As a leader in the non-invasive prenatal genetic testing industry, BGI Dx has always devoted itself to independent research and development as well as to innovation connected to broader genomics technology conversion applications. BGI Dx has published more than 30 academic articles related to non-invasive prenatal genetic testing and has 72 relevant patent applications spreading over a dozen countries in Asia, America and Europe. NIFTY® is offered in more than 2000 healthcare providers covering 52 countries including England, Australia, Spain, Singapore, Israel, Czech Republic, Turkey, Thailand and China. As of August 2014, nearly 400,000 test samples have been processed with accuracy rate for trisomies 21, 18 and 13 of more than 99.9%.
The multinational authorization for the patent of non-invasive prenatal genetic testing technology for NIFTY® indicates that non-invasive prenatal genetic testing has undergone a new breakthrough. BGI Dx is dedicated to continuing the development of new genetic testing technologies and expanding the non-invasive prenatal testing industry for the benefit of all.
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About BGI Dx (BGI Diagnostics Co.)
Since its foundation, BGI Dx has always devoted itself to multidisciplinary genomics research with the aim of applying cutting edge discoveries to the field of medical testing in an economical, simple and effective manner. BGI Dx's mission is to improve the process of diagnosis and treatment options for life limiting birth defects and critical illnesses such as cancer and monogenic diseases.
BGI Dx has developed a series of test services based on multidisciplinary technologies and approaches, including independent core technologies such as high throughput sequencing, high sensitivity mass spectrum and big data analysis. BGI Dx's test product provision covers the entire human lifecycle from conception, pregnancy and birth, to old age.
About non-invasive prenatal genetic test （NIFTY®)
Through collecting a small sample of peripheral blood from the pregnant woman, NIFTY® is able to extract cell free fetal DNA. Utilizing next generation high throughput sequencing technology combined with bioinformatics analysis, NIFTY® provides a highly accurate risk rate of occurrence for chromosomal aneuploidy in the fetus.
As a non-invasive prenatal test, NIFTY® avoids the risk of miscarriage associated with invasive diagnostic procedures such as amniocentesis, which carries a 1% risk of miscarriage.
As of August 2014, non-invasive prenatal genetic tests provided by BGI Dx are offered by more than 2000 healthcare providers in more than 52 countries including England, Australia, Spain, Singapore, Israel, Czech Republic, Turkey, Thailand and China, with nearly 400,000 test samples processed so far, and with an accuracy rate of more than 99.9%. Non-invasive prenatal testing is particularly suitable for pregnant women who have certain indications including pregnant women who have received a high risk result from serological screening; pregnant women who have experienced habitual abortion; pregnant women with puncture contraindications; pregnant women not suitable for or unwilling to undergo invasive prenatal diagnosis such as amniocentesis and pregnant women of advanced maternal age.
BGI Genomics Sees Diagnostics Core Business Rebounding, Overseas Business Growing
NEW YORK - BGI Genomics has seen growth in several areas of its core diagnostic testing business during the first half of 2021 and is working on upgrading its tests in reproductive health. Late last month, the publicly traded clinical genetic testing and research services arm of China's BGIGroup reported that total revenues in H1 declined due to decreasing demand for COVID-19 testing,while its cancer prevention and control, reproductive health including its flagship NIFTY noninvasive BGI prenatal test, and infection prevention and control businesses grew. Li Ning, VP of BGI Group, said the regular business is "healthy" even as COVID testing demand is declining. He noted that the four biggest non-COVID drivers of revenue for the six-month period were cancer testing, infection prevention, reproductive health, and overseas growth.
The NIFTY test, which was launched in 2014 after approval from China's National Medical Products Administration, has been distributed in more than 60 countries, and more than 9.4 million tests have been performed in total, Li said.
Beyond NIFTY, BGI has other reproductive health tests that it's working to upgrade. The company has upgraded the algorithm used in its carrier screening test to expand the coverage of diseases it can detect and to add services like safe medication guidance.
The firm has also launched a multicenter genetic disease screening research project in China using its high-throughput sequencing technology to offer genetic testing for a variety of diseases and establish a genetic screening system for newborns.
Meantime, BGI Genomics has improved the coverage of its neonatal hearing loss screening test, Li said. He also said that tandem mass spectrometry for neonatal disease screening is worth exploring, noting that "the application of tandem mass spectrometry technology in the screening of neonatal genetic and metabolic diseases has not been widely used in China." Li didn't specify what tests or applications BGI Genomics is exploring using the tech, however.
BGI Genomics' overseas business is also growing. The company has several localized in vitro diagnostic manufacturing centers globally and has received regulatory clearance for its products in a range of countries, including CE marks for its thalassemia, lung cancer, and intestinal cancer tests, Li said.
The firm's most important region in terms of business value outside of China is the rest of Asia, including Hong Kong, Macao, and Taiwan, along with Oceania. The biggest growth in the first half of 2021 occurred in the Americas, with revenues up 47 percent, and in Europe and Africa, where revenues grew nearly 25 percent.
Even though demand isn't as strong as in 2020, BGI Genomics isn't done with COVID-19 testing.
Along with developing and launching its COVID-19 tests, the firm has built mobile laboratories, called Huo-Yan labs, across the world to provide rapid SARS-CoV-2 testing in regions where testing is limited. The labs are located in a variety of settings, including airports, and are a way "to export testing technology and equipment" to areas where it's needed most, Li said.
The COVID testing labs are mounted on either a vehicle or trailer platform and can be built and moved quickly, he said. Most of the Huo-Yan labs are operated by local public health departments or local authorities, although some have been commissioned by BGI, he added. BGI Genomics provides the training and technical support services for the lab, but the actual testing program is determined by the public health department, he said.
They largely perform PCR testing, with a small amount of antigen testing, and mostly use SARS-CoV-2 tests developed by BGI, according to Li. Those tests include virus sequencing assays; nucleic acid detection assays; rapid nucleic acid, antibody, and antigen tests; and neutralizing antibody assays; as well as multiplex assays for SARS-CoV-2 and influenza, he said.
So far, more than 90 Huo-Yan labs have been established in 30 countries with a maximum daily testing capacity of 1 million tests, Li said.
Shaping the future of omics for all
The ‘3,000 Rice Genomes Project’, published in Nature in 2018, analysed genetic variation, population structure and diversity among Asian cultivated rice strains.Credit: luxiangjian4711/iStock /Getty
Powered by self-developed technological platforms and laboratories worldwide, BGI China, a genome sequencing organization headquartered in Shenzhen, China, has been rapidly expanding since 1999 to support milestone projects ranging from human, rice, silkworm to genetic diversity in the world’s deepest ocean trench.
In 2021, Jian Wang, BGI co-founder and chairman, was part of an expedition to the western Pacific Ocean, helping to sample organisms living 10 km below the surface. “Our team is keen to support international collaborations, such as the Mariana Trench Environment and Ecology Research Project,” says Wang. “We hope that the digitized genetic materials will shed light on questions about the origin of life, biodiversity, and extreme environmental adaptation.”
BGI’s sequencing capabilities have contributed to more than 50% of the world’s genetic sequencing projects, including input to the Human Genome Project (HGP), according to George Church, a geneticist and professor at Harvard Medical School. Results from the international research effort to determine the DNA sequence of the entire human genome were released in 2003.
BGI was set up in 1999 to participate and contribute to the HGP. Wang and his team completed the sequencing, assembly and analysis on the tip of the short arm of chromosome 3, which was then estimated to account for about 1% of the HGP.
The HGP was an important chapter for China, and the work contributed to BGI’s development of technologies for new studies including the the first diploid genome sequence of an Asian individual, the International Giant Panda Genome Project, SARS, as well as surveys on Asian rice. Since April 2000, BGI team has enabled new understanding of the evolution and relationship between rice species, paving the way for improved quality, resilience and yield. The HGP broadens the scope for exploration and understanding of other organism genomes. The rice gene map was described in the April 2002 cover story of Science.
Jointly initiated by BGI, the Chinese Academy of Agricultural Sciences and the International Rice Research Institute, the ‘3,000 Rice Genomes Project’, published in Nature in 2018, analysed the genetic variation, population structure and diversity among 3,010 diverse Asian cultivated rice, covering 92% of rice genes, and obtained 32 million high-quality single nucleotide polymorphisms (SNP) and insertion and deletion of nucleotides into genomic DNA (Indels), allowing researchers to divide Asian cultivated rice into subgroups more accurately.
Sequencing the genomes of Asian cultivated rice, O. sativa Xian Group (籼) and O. sativa Geng Group (粳), marks a milestone in agricultural research. Previously the groups were incorrectly named Indica and Japonica, which do not fully represent their relationship and evolution.
Shuaishuai Tai, an agriculture geneticist in front of a Chinese character representing the rice species, O. sativa Geng Group (粳).Credit: BGI
Shuaishuai Tai, a BGI Genomics researcher specializing in agriculture genetics, explains that through SNP analysis, and the comparative analysis of the genomes of structural variation (SV), their work supports the multiple origin hypothesis of different rice lineages.
There are a large number of SVs in Asian cultivated rice, with an average of about 12,000 SVs per genome, which may be the genetic cause of Xian/Indica and Geng/Japonica hybrid sterility, as well as hybrid decline.
“One of the biggest challenges we overcame 10 years ago was the very low sequencing throughput, and scarce resources. In order to complete the sequencing of the rice genomes, BGI Genomics had to use all the sequencing capacity in Shenzhen and Hong Kong. But after years of innovation, sequencing power is now more than 100 times faster than in the early 2010s,” says Tai.
“Around 2019, when we performed the Silkworm Pan-genome Project (sequenced more than 1,000 silkworm genomes) cooperating with Southwest University in Chongqing, China. The DNBSEQ-T7 sequencer, developed by MGI, could produce 6T of data in one day,” adds Tai.
Bring Life Sciences to Life
Chong Tang, deputy director of research and development department at BGI Tech, has also led his team through a web-based system called Dr. Tom Data Visualization Solution (Dr. Tom), which promotes flexibility and innovations through convenient analysis, visualization, and interpretation of RNA data types.
Chong Tang, deputy director of research and development department at BGI Tech.Credit: BGI
Dr. Tom aims to enable researchers from different fields, as well as collaborators with little or no bench lab experience, to share their data and findings more easily. It has become one of the mainstream cloud RNA analysis platforms in China, with more than 15,000 users scientists and researchers from more than 20 countries. “Our visualization feature is meant to be interactive for idea exchange, encouraging communications and collaborations,” says Tang.
Ensuring a large amount of data runs smoothly across the network is another design priority for Tang. “Since the development of next-generation sequencing, processing the data produced is simply not possible for most computers,” says Tang. “We are still improving our design, but what used to take a day to quantify genetic data mining now only needs one to two hours.”
Affordable sequencing at a faster speed allows health professionals to apply genetic data and clinical practices in diagnosis and treatment. Since 2019, BGI has provided a rapid Whole Genome Sequencing (rWGS) service, executed with BGI’s proprietary DNBSEQTM technology platform, to accelerate large sequencing data. Designed for researchers working on time-sensitive experiments, and available for different branches of science, especially in health care, BGI can provide rWGS results within 10 business days, significantly accelerating the sequencing process.
In 2021, BGI Genomics teamed up with the West China Hospital of Sichuan University to complete the sequencing of 100,000 people with rare diseases within five years.
Using the world-leading sequencer to complete genome analysis and mutation information, the project aims to bring hope for an estimated 20 million people in China with rare diseases, while enhancing diagnosis and treatment standards.
Saudi Tibbiyah form JV with BGI Health subsidiary to offer clinical testing services
Saudi Tibbiyah form JV with BGI China Health subsidiary to offer clinical testing services
RIYADH: Arabian International Healthcare Holding Co., known as Tibbiyah, signed a joint venture agreement with BGI Almanahil Health for Medical Services to establish a limited liability firm under the name of Saudi Advanced Medical Lab.
This new firm, 50-50 owned by Tibbiyah and BGI Almanahil, will provide testing and bio-information services for clinical laboratories, according to a bourse filing.
Tibbiyah CEO Alaa Ameen (Supplied)
Tibbiyah CEO Alaa Ameen stated that the establishment of SAML represents a milestone in Tibbiyah’s ongoing investment in healthcare services, which is in line with its strategy to diversify into healthcare.
This will be Tibbiyah’s second joint venture within a week, as the company announced yesterday that it had signed an agreement with European Unilabs Diagnostics AB to establish a limited liability firm to provide diagnostic imaging services.
