BioSURE Data Sheet

Overview: BioSURE is a UK company specializing in the provision of rapid in-vitro diagnostic testing solutions. They focus on the development, manufacturing, and distribution of rapid tests. It developed the first CE-marked self-test for HIV in 2015. Test Name: BioSURE COVID-19 Self-Test (in partnership with Mologic) Testing Type: Lateral flow chromatography assay Technology: The BioSURE COVI-19 Self-Test will be an antibody test that will use technology that is very similar to that of a pregnancy test. The test will detect the presence of IgG antibodies to the COVID-19 virus, not COVID-19 itself. The BioSURE COVID-19 Self-Test will be as easy as 3 simple steps. Prick, Suck and Poke. Test Sample Type: Finger-prick blood sample Time to Result: 11 minutes Testing Location: Home Complementary Products: None - each test includes all the components. Effectiveness: Clinical sensitivity (days 14-21) - 98%​, Clinical specificity - 96%​, Independently validated by Liverpool School of Tropical Medicine and St George's, University of London. Also submitted to Public Health England.  Current Status: In development and price available on request. Business Model: Partnership with Mologic (Mologic test within BioSURE kits), and Mologic can produce 40 million tests a year. Organization: Public company, and Brigette Bard is the Founder and CEO. 11-50 employees work at the firm, and the organization has over 5 years of extensive research and performance data for HIV self-testing. The BioSURE HIV self-test was launched in 2015 and was the first HIV self-test to use blood.

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