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First-Ever COVID-19 Test Measures Neutralizing Antibodies that Prevent SARS-CoV-2 from Entering Host Cells

By HospiMedica International staff writers
Posted on 09 Mar 2021
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The first-ever COVID-19 rapid diagnostic test for measuring levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells has successfully completes point-of-care clinical trials.

AXIM Biotechnologies, Inc. (San Diego, CA, USA) has successfully completed point-of-care clinical trials on its ImmunoPass rapid test that semi-quantitatively measures levels of COVID-19 neutralizing antibodies to help understand COVID-19 immunity, validate vaccine’s effectiveness and estimate how long the vaccine will be effective in patients. The company conducted two studies with the main aim of identifying the ability of operators to successfully utilize ImmunoPass in order to accurately measure each participant’s level of neutralizing antibodies. Study findings revealed that operators found ImmunoPass easy to use and that they encountered no issues in using the company’s test to measure participants’ COVID-19 neutralizing antibodies.

AXIM’s rapid (10-minute) serological diagnostic test could be used for measurement of neutralizing antibodies in individuals who have recovered from COVID-19 and/or received a vaccine and to provide an “Immunity Passport” so that they can go back to work and school or participate in social gatherings without risk of infecting others. The test could also be used for screening plasma collected from individuals recovered from COVID-19 so that patients fighting COVID-19 can be treated with plasma containing high levels of neutralizing antibodies.

In preclinical research, ImmunoPass has already been proven to work with 97.8% accurately in plasma and serum and works on all strains of COVID, so newly-discovered strains will not affect its efficacy. ImmunoPass has shown a significantly better statistical correlation with SARS-CoV-2 neutralization assays than the currently available antibody tests. Since ImmunoPass agrees well with live virus-based assays, it could serve as an effective low-cost alternative to lab-based assays for monitoring large numbers of vaccine recipients for neutralizing antibodies. The company is currently compiling the study results and plans to file an Emergency Use Application (EUA) with the US Food and Drug Administration (FDA) for the use of ImmunoPass in detecting COVID-19 neutralizing antibodies in whole blood at point-of care locations.

“These studies are a critical step in our goal of getting ImmunoPass to point-of-care locations as quickly as possible to aid in slowing the spread of the COVID-19 virus. Our study results demonstrate that ImmunoPass is easy to operate in addition to being affordable, portable, quick and accurate,” said AXIM Biotech CEO John W. Huemoeller II.

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AXIM Biotechnologies, Inc.


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