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RT-PCR TEST KIT
COVID-19 SOLUTION

COVID-19 SOLUTIONS

Our Covid-19 Mitigation Solutions

 

1/4 : BGI HUO-YAN LABORATORY

Two Testing Labs Implemented

Facing the spread of COVID-19 in a growing number of countries across the world, it is critical that high throughput detection labs are built up in order to increase the efficiency of diagnosis. As of March 3rd, 2020, there are a total of 90,893 reported cases of COVID-19 globally, and 3,110 deaths, according to the WHO. In the past 24 hours, China reported 129 cases, the lowest number of cases for China since the 20th of January. Outside China, 1,848 cases were reported in 48 countries. 12 countries reported cases for the first time, and there are 21 countries with one case currently. WHO-Coronavirus disease 2019 (COVID-19) Situation Report.

BGI has been actively engaged in the fight against the COVID-19. On January 14, BGI successfully developed a Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2), which can issue results in 3 hours. The kit was certified by National Medical Products Administration and received CE-IVD marking. The kit is already widely used in China, providing a scientific basis for diagnosis of suspected cases and the discharge of recovered patients.

Development of the Huo-Yan Laboratory

On February 5th the Huo-Yan Laboratory, an emergency test laboratory run by BGI and designed to handle 10,000 samples daily to detect 2019-nCoV, started trial operation in Wuhan. The Wuhan Laboratory has been promptly followed by newly built or upgraded Huo-Yan labs in Shenzhen, Tianjin, Beijing, and Shanghai, in a total of 12 cities across the country. The daily throughput totals up to 50,000 tests per day, further upgradable to 80,000 per day when necessary.

As of March 4th 2020, the Huo-Yan laboratories have completed a total of 360,000 test samples across China, enabling a rapid response to the outbreak including diagnosis of suspected cases, identification of suspected cases, release of recovered patients, and screening of close contacts and high-risk groups.

2/4 : BGI RT-PCR TEST KIT

Can be supplied with RNA Extraction Kit and Consumable

BGI Genomic’s Real-Time Fluorescent RT-PCR kit for detecting 2019-nCoV (SARS-CoV-2) is a qualitative in-vitro nucleic acid amplification assay used to detect SARS-CoV-2 using reverse transcription PCR from throat swab and Bronchoalveolar Lavage Fluid (BALF) samples. The kit is widely used for rapid detection and outbreak control of COVID-19 in China. BGI is distributing its RT-PCR kits to more than 180 countries and regions around the world.

With its high specificity, sensitivity and rapid response, it can effectively assist the diagnosis of disease and improve the diagnosis efficiency.

Product Features:-

  1. NMPA Cert/CE/FDA Authorized/PMDA Approved;
  2. Results issued in 3 hours;
  3. One Step-Reaction; and
  4. High Sensitivity and Specificity.

LOD of 100 copies/mL. No cross-reactivity with human genome and other pathogens including 54 pathogens, such as human coronavirus OC43, 229E, HKU1 and NL63(HCoV-OC43, HCoV-229E, HCoV-HKU1, HCoV-NL63) etc.

Whole-Process Quality Control. An internal control was set to monitor the laboratory procedures including nucleic acid extraction, Revert transcription and amplification in each reaction.

  • Compatible to Universal Real time PCR system; and
  • Over 1.2 Million Tests kits have been produced.

The kits are internationally available, and are currently being distributed to more than 50 countries and regions worldwide. Each kit provides reagents sufficient for 50 reactions.

3/4 : BGI ELISA lgG/lgM KIT

Antibody Detection Kit

BGI Genomic has developed SARS-CoV-2 IgM and IgG antibody detection kit. SARS-CoV-2 ELISA kit uses the principle of capture method (ELISA) and indirect capture method (ELISA) to detect SARS-CoV-2 IgM and IgG antibody in human serum or plasma. The kits are CE marked. Detection of IgM antibodies tends to indicate recent exposure to SARS-CoV-2, whereas the detection of COVID-19 IgG antibodies indicates virus exposure for a relatively long period.

Antibody ELISA test could not only be used as a supplementary test for suspect with RT-PCR negative cases for COVID-19, but also as a supplementary detection indicator in conjunction with nucleic acid detection in the diagnosis of suspected cases. Antibody ELISA test improves the sensitivity of early diagnosis and identify the patients during periods of incubation or early infection or asymptomatic infection.

Advantages :-

  1. High Specificity – The clinical specificity of IgM ELISA kit is 96.76%, and that of IgG ELISA kit is 98.38%;
  2. High Sensitivity – The sensitivity of IgG ELISA kit is 99.16% (more than 20 days), The sensitivity of IgM ELISA kit is 98.06% (10-19 days). And the sensitivity of total IgG and IgM is more than 98.71%;
  3. Satisfactorily homogeneous – High reproducibility, the coefficient of variation (CV) is no larger than 10%;
  4. High Throughput – With automated ELISA system, over 20,000 assays can be processed in one day;
  5. Convenient – No space separation required by majority of PCR kit, suitable for high throughput test; and
  6. Cost-effective – Cost-effective systems and reagents; less time and effort are required for operation.

Suitable to :-

  1. Validate the SARS-CoV-2 infection on suspected cases;
  2. Find potential asymptomatic SARS-CoV-2 carriers;
  3. Identify the immunized population;
  4. Determine if the patients can be discharged from the hospital or have a second infection; and
  5. Test the efficacy of vaccines.

 

4/4 : BGI HUO-YAN AIR LAB

Turnkey End-to-End Movable Testing Lab Solution

Since the outbreak of the novel coronavirus epidemic, countries around the world have been working together to fight the epidemic in the face of the world’s biggest public health crisis in a century. The “fight against the epidemic” is like putting out a fire, providing a full range of services in response to the novel coronavirus epidemic, from nucleic acid screening and confirmation, differential diagnosis to future scalable immunological evaluation. To quickly solve the problem of lack of biosafety laboratories in various countries and regions, and to help the global fight against the epidemic, BGI, Etopia and Tongji University co-designed and launched the “Huo-Yan Air Lab” – supplying the complete solution of mobile inflatable BSL-2 l laboratory for urgent use. And the global unveiling ceremony was held on April 3, 2020, at the National GeneBank in Shenzhen, gaining widespread attention. The Huo-Yan Air Lab not only improves the testing efficiency, but also has the significant features of fast implementation, wide dissemination, and efficient landing, and optimally integrates the recent experience of BGI’s novel coronavirus testing into the laboratory.

Features

Compared with traditional laboratories, this project is characterized by the fast set-up, low transportation requirements, high testing throughput, intelligent and high tech. After packing, it can be airfreighted by cargo plane for flexible site selection, fast layout, fast construction, fast start-up, and can be flexible according to demand adjusting configurations to help countries rapidly establish and upgrade nucleic acid testing capabilities for SARS-Cov-2.

The Huo-Yan Air Lab takes into account global biosafety requirements and industry norms and uses PVC materials with high flammability, abrasion resistance, and stability as the main building material.

It is equipped with four functional areas, including sample receiving area, reagent preparation area, sample preparation area, and amplification area, and auxiliary conversion spaces such as optical interactive access control system, medical waste outlet, buffer room, and dressing room, etc. It is equipped with a biological safety cabinet, automatic nucleic acid preparation workstation, and qPCR instrument, automated ELISA analyzer and genetic sequencers and other advanced laboratory equipment can be installed upon request.

Qualifications, Patents, Standards

  1. On May 1, 2020, the Harbin Huo-Yan Air Lab (air-film version) has undergone initial PCR laboratory acceptance and a Level 2 biosafety laboratory filing.
  2. On June 5, 2020, the Huo-Yan Air Lab at the National GeneBank in Shenzhen was awarded the Quality of Clinical Testing in Guangdong Province.

The “Certificate of Technical Audit of Clinical Gene Amplification Laboratory” issued by the Control Center, which recognizes the layout, air pressure, air membrane laboratory. Temperature, humidity and environmental evaluation test results meet clinical PCR laboratory and testing requirements. The reviewers support the innovative spirit, rigorous quality control attitude, efficient experimental procedures, and the innovative and innovative approach of the Huo-Yan Air Lab. The laboratory’s proven management experience has been replicated nationally and globally.

At the same time, it has applied for invention, utility model and international PCT patents on “Inflatable Membrane Structure Virus Detection Laboratory, Biosafety Laboratory, and Cladding Structure Virus Detection Laboratory”; issued the enterprise standard “Inflatable Membrane Structure Virus Detection Laboratory Construction Guide”, and the group standard and national standard are actively under the application.

Applications

Since the world premiere of the Huo-Yan Air Lab on April 3, 2020, we have been continuously optimizing each function and laboratory environment according to the requirements of PCR laboratories in China, and have rapidly iterated to the third version according to actual user needs.

Qualifying

Our Covid-19 solutions are only supply/provided to Ministry of Health Malaysia approved government institutes and private medical laboratories. Read More

Movable COVID-19 Total Testing Lab Solution Slide