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

Autobio Diagnostics

Business Name: Autobio Diagnostics
Business Genre:
Business Description:

Focus on penetration and improvement of medical laboratory technology,serving for human health” and strives to provide both cost-efficient and high-quality products to medical laboratories [1]

State: Zhengzhou
Country: China
Data/Evidence of Effectiveness: Early onset with poor sensitivity, infection > 15 days: 95.07 % positive agreement [3]
Complimentary Products Needed to Perform Test: “Sample dilutent, Cassette, alcohol swabs, centrifuge, sample collection containers [3]”
Setting of Care: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests [2]
Current Status / Clinical Development Stage / Expected Milestones: Received EUA approval, ready for purchase
Funding & Ownership : Public [5], Cap 65.882 B [6]
Business Model: They sell instruments and kits related to immunoassay and microbiology [4]
IP: N/A
History & Origins : Founded in 1998, Autobio has been focusing on the common development of both reagents and instruments. Product catalogue covers many IVD fields, including Immunoassay, Biochemistry, Microbiology, which can provide medical laboratories with comprehensive solutions and service. [1]
Date EUA Issued: 04/24/2020 [2]
Sources: “[1] http://www.autobio.com.cn/en/index.php?m=content&c=index&a=lists&catid=15 [2] https://www.fda.gov/media/137364/download [3] https://www.fda.gov/media/137367/download [4] http://www.autobio.com.cn/en/index.php?m=content&c=index&a=lists&catid=10 [5] https://www.crunchbase.com/organization/autobio-diagnostics#section-overview [6] https://finance.yahoo.com/quote/603658.SS?p=603658.SS&.tsrc=fin-srch [7] https://www.bloomberg.com/profile/person/18889490”
Organization: Yongjun Miao (Chairman) [7]
No. Tests Per Day: serology strip, > 2000/day
Time to Result: 15 to 20 minutes [3]
Test Sample Type: human plasma from anticoagulated blood (Heparin/ EDTA/ sodium citrate) or serum [2]
Technology Overview: Test membrane are precoated with two mouse anti-human monoclonal antibodies (anti-IgG and anti-IgM) on two separated test lines. SARS-CoV-2 recombinant spike protein antigen reagents which can specifically bind toSARS-CoV-2 antibodies (IgM and/or IgG), are bound to colloidal gold and sprayed on conjugation pads. The labeled gold colorimetric reagent is used to form a visible red/pink line. [3]
Testing Type: serology IgG/ IgM [3]
Test Category: SEROLOGY
Test Name: Anti-SARS-CoV-2 Rapid Test
Clinical Application & Need: Immune response to SARS-CoV-2, indicating recent or prior infection [2]
Age of Company: 1998

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