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Fast Covid-19 Antibody Test Gets BARDA Funds

Drop of blood

(Alden Chadwick, Wikimedia Commons)

23 June 2020. A company developing point-of-care diagnostics is receiving a federal government contract for a one-drop blood test that detects Covid-19 virus antibodies in five minutes. Biomedical Advanced Research and Development Authority, or BARDA, is awarding MBio Diagnostics in Boulder, Colorado a $629,595 contract to advance its Covid-19 antibody panel, for detecting antibodies to SARS-CoV-2 viruses responsible for infections.

MBio Diagnostics creates medical diagnostics with a technology called LightDeck that employs microfluidics, or lab-on-a-chip components with planar waveguides, guided optical beams for detecting biomarkers, or protein indicators, in this case SARS-CoV-2 antibodies. The microfluidics components offer multiple channels in a self-contained disposable cartridge that uses only a drop of blood or other fluid, illuminated by laser waveguides, with fluorescent imaging that the company’s software measures and quantifies to deliver results.

The company says its Covid-19 antibody panel is designed to detect two types of SARS-CoV-2 antibodies, immunoglobulin M and G. Immunoglobulin M, or IgM, antibodies are found in blood and lymph fluid, and are the first antibodies produced in response to an infection. The presence of IgM antibodies suggest that the individual became infected within the previous 30 days. Immunoglobulin G, or IgG, are the most common antibodies, found in most body fluids. They also develop more slowly, are detectable from 10 to 14 days following infection, and are more likely to offer longer-term protection against further infections.

These antibody tests, also known as serology tests, can assess immune response to Covid-19 infections and confirm previous infections. They can also help determine community spread of the disease, and trace further infections from contacts with infected individuals. In addition, the company says its antibody panel can determine if IgG antibodies are in high enough concentrations to neutralize SARS-CoV-2 viruses already infecting a patient for donated convalescent plasma, a potential treatment for Covid-19 infections. On Friday, Science & Enterprise reported on a large-scale clinical trial showing convalescent plasma caused few severe side effects when given as a Covid-19 treatment.

MBio says its Covid-19 antibody panel returns detection and measurement of IgM and IgG antibodies in five minutes. The company adds that most other antibody or serology tests detect the presence of antibodies, but do not give quantitative measurements, and usually take at least twice as long.

BARDA is a division of the U.S. Health and Human Services department that funds emergency medical countermeasures to counter threats from bioterrorism and pandemics. Because the antibody panel does not need advanced training to operate, BARDA envisions its use in non-professional settings, such as drive-through or walk-up testing centers.

MBio Diagnostics says the BARDA contract will make it possible to complete work on the Covid-19 antibody panel for submission to the Food and Drug Administration for an emergency use authorization. “We are pleased to join the fight against Covid-19 and expand the capabilities of the LightDeck platform in partnership with BARDA,” says MBio CEO Chris Myatt in a company statement. “The funding will allow MBio to rapidly commercialize our first in vitro diagnostics product, the Covid-19 antibody panel.”

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