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COVID-19 Portable Test Kit Technical Background

COVID-19 InstaTest Distributors

*WMI Is the abbreviation of the US Corporation acting on behalf and partnering with its multibillion dollar manufacturer with a capacity to produce 90 Million Kits/Month

The Center for Integrated Global Biomedical Sciences at the University at Buffalo to Establish
COVID-19 Antibody Implementation Research Program

BUFFALO, NY – June 5, 2020- Gene D. Morse, Director of the Center for Integrated Global Biomedical Sciences at the University at Buffalo, is leading a COVID-19 Implementation Research Program that will investigate the use of rapid antibody testing and quantitative antibody testing at several locations including facilities in Western New York. The research program led by Dr. Morse, a State University of New York Distinguished Professor in the UB School of Pharmacy and Pharmaceutical Sciences, will initially evaluate leading-edge quantitative serology diagnostic equipment utilizing WMI’s* state-of-the-art portable quantitative microfluidic chemiluminescent
serology technology for SARS-CoV-2.

The implementation research will identify the role of rapid and quantitative testing for individuals with COVID-19, their family members and other high-risk groups. The project in collaborate with regional programs (business, academic, government) to investigate the role for antibody testing in re-introducing the workforce and economic re-engagement for the region. As the project is established, additional laboratories with validated quantitative antibody assays will be engaged to compare results from different antibody testing systems.

WMI has donated its fourth generation, quantitative, microfluidic chemiluminescence M2 and M5 analytic instruments to the project as well as several thousand disposable lateral flow immunoassay disposable test kits and microfluidic reagent chips used to detect both COVID-19 antibody and antigen profiles. The M2 and M5 are the world’s first portable quantitative fourth generation serology machines. WMI has also filed an Emergency Use Authorization application with the U.S. Food and Drug Administration for its disposable rapid COVID-19 test kits. The research program will seek to enhance the region’s workforce planning while also nurturing new international business collaboration with WMI.

WMI has registered with the FDA

Additional Application Information
On March 16, 2020, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019″ during the Public Health Emergency.

On March 26, WMI received its submittal confirmation from the FDA. Under the announced FDA policy, upon filing its submittal, WMI was authorized to market and distribute “WMI COVID-19 IgM / IgG Rapid Test Kits” in the United States for diagnostic use while it awaits a final decision on its FDA EUA application.

This CDC authorized test is in review by the FDA. A negative test result does not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43 or 229E.”

Understanding Antibody Tests

Understanding Antibody Tests Antigens are molecules capable of stimulating an immune response.Each antigen has distinct surface features, or epitopes, resulting in specific responses.

An antibody test reveals if a person has already been exposed to an infection, by detecting antibodies in their blood or serum. This can be done by a laboratory based test such as an ELISA (Enzyme-Linked Immunosorbent Assay) or CIA (chemiluminescent immunoassay), or a point-of-care test based on lateral flow technology. Our Disposable Test Kit does this with a sample of finger blood.

Antibody tests are not usually used to diagnose current infection as it takes the body some time to produce antibodies. During the period before the adaptive immune system kicks in, the fast-acting and non-specific innate immune response combats infection. A negative test result may occur if the test is taken too soon after infection before antibodies have been produced by the body. False positive test results could also occur due to cross-reactivity.

Antibody tests are useful to help track the spread of a disease, identify those who should be prioritized for vaccinations, and highlight potential donors for convalescent plasma therapy.

An antigen test reveals if a person is currently infected with a pathogen. Once the infection has gone, the antigen disappears.

Unlike nucleic acid based tests such as PCR, which detect the presence of genetic material, antigen tests detect proteins, such as those found on the surface of a virus. Accuracy can be a problem, with antigen tests typically having a much lower sensitivity than PCR.

However, they usually provide test results rapidly, are relatively cheap, and can be more amenable to point-of-care use, which could make them more suitable for testing in the community and in remote regions.