NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Jiangsu Superbio Biomedical Co., Ltd.

Business Name: Jiangsu Superbio Biomedical Co., Ltd.
Business Genre:
Business Description:

Biotech company specializing in solutions for DNA database construction, laboratory construction, genetic detection instruments and reagents, etc. Superbio Biomedical has built medical inspection laboratories, food/medicine/environment safety inspection laboratories, precision medical centers, DNA database construction service centers, forensic and medical reagent R&D centers, biological information centers, software R&D centers, security service, judicial service, medical and clinical service, and comprehensive health service. [2]

City: Nanjing
State: Jiangsu
Country: China
Data/Evidence of Effectiveness: Company tested kit on nucleic acid positive and negative blood samples. Failed detection of IgG strip if the sample was diluted 80 times (71.4 ng/mL) [1]. Detection accuracy on positive samples was 100% and the negative samples was 95.8% [1].
Complimentary Products Needed to Perform Test: All reagents provided [1]
Setting of Care: Professional use [1]
Current Status / Clinical Development Stage / Expected Milestones: Completed European In Vitro Diagnostic Medical Devices Directive [1]. Qualified for European Union Market Access [1].
Funding & Ownership : Private [8].
Business Model: They create solutions associated with DNA database construction, laboratory construction, genetic detection instruments and reagents [3]
IP: N/A? Not according to their patents webpage: http://www.superbioglobal.com/public/portal/advantages/technologypatterns.html
History & Origins : Company was established in 2011 [2] and offered forensic science services [5]. They specialize in Biotechnology, Genetic analyzer, DNA database construction, Reagents, DNA sequencing, NGS, Biotech, genetics, DNA, DNA testing, and gene detection [3]. From their website, it seems like the SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) Kit is their first infectious disease testing kit [1-2].
Date EUA Issued: EUA pending [7]. Completed European In Vitro Diagnostic Medical Devices Directive [1]. Qualified for European Union Market Access [1].
Sources: 1. http://www.superbioglobal.com/public/portal/wedo/postdetail/id/50.html 2. http://www.superbioglobal.com/public/portal/aboutus.html 3. https://www.linkedin.com/company/jiangsu-superbio-biomedical-technology-co-ltd/about/ 4. http://www.superbioglobal.com/public/portal/advantages/elitestuff.html 5. http://www.superbioglobal.com/public/portal/advantages/experience.html 6. http://www.superbioglobal.com/public/portal/contackus.html 7. http://blog.rapidmicromethods.com/2020/03/overview-of-current-covid-19-diagnostic.html 8. https://www.crunchbase.com/organization/superbio#section-overview
Organization: Dr. Zhang Minghang- Chief Scientist and Technical Leader Dr. Xiang Guobing- Chief Technology Officer Dr. Su Xuefeng- R&D Director [4]
No. Tests Per Day: serology strip >2000/ day
Time to Result: 8 minutes [1]
Test Sample Type: Serum, plasma, blood [1]
Technology Overview: Test uses fluorescence immunochromatography. Test card contains colloidal gold- labeled SARS-CoV-2 antigen. Nitrocellulose membranes fixed with two test lines (M line and G line) and one quality control line (C line). When an appropriate amount of sample is added to the sample well of the test card, the sample moves by capillary action. If the sample contains IgM/IgG antibody of SARS-CoV-2, the antibody will bind to the colloidal gold-labeled SARS-CoV-2 antigen. This complex will be captured by anti-Human monoclonal IgM antibody or monoclonal IgG antibody immobilized on the nitrocellulose membrane, forming a purple red M line or G line, and showing that the sample is positive for IgM or IgG antibody [1].
Testing Type: Detects IgM and IgG antibodies simultaneously [1]
Test Category: SEROLOGY
Test Name: SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit (Colloidal Gold) [1]
Clinical Application & Need: IgM vs. IgG antibody detection [1]
Age of Company: 2011 [2]

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