FDA Grants First Ever EUA to COVID-19 POC Antibody Test for Use with Fingerstick Blood Samples

By LabMedica International staff writers
Posted on 30 Sep 2020

Image: FaStep COVID-19 IgG/IgM rapid antibody test kits (Photo courtesy of Adial Pharmaceuticals, Inc.)

The US Food and Drug Administration (FDA) has issued the first emergency use authorization (EUA) for a serology (antibody) point-of-care (POC) test for COVID-19 using fingerstick blood samples as compared with current approved tests that only utilize serum, plasma, or a venous blood draw.

Adial Pharmaceuticals, Inc. (Charlottesville, VA, USA) has secured the FDA's EUA for the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device. The test was initially authorized for emergency use in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection, but as with all competing rapid COVID-19 test kits, was not yet authorized for fingerstick blood sample use. Following the FDA's EUA, the fingerstick blood samples can now be utilized with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in POC settings, including doctors' offices, hospitals, urgent care centers, emergency rooms, or other locations where there is a licensed healthcare professional.

Adial has commenced sales of the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals. The antibody test kits distributed by Adial are lateral flow assay, 10-minute, ‘instant' point-of-care test devices for the qualitative detection of lgG and lgM antibodies specific to SARS-CoV-2 virus in fingerstick whole blood, venous whole blood, serum, and plasma. During testing, the specimen reacts with antigen coated particles in the test cassette after droplets of blood from the subject are placed on the cassette's coated membrane.

"The issuance of the EUA for the first point-of-care antibody test for COVID-19 in the US using fingerstick blood samples is expected to provide an important competitive advantage, which should support more widespread adoption of the Assure/FaStep COVID-19 IgG/IgM Rapid Test Device as a fast, convenient and reliable method for COVID-19 serology testing," said William Stilley, Chief Executive Officer of Adial Pharmaceuticals. "We see a market demand for these instant and efficient antibody tests to help combat the international COVID-19 pandemic with the addressable global COVID-19 rapid test kits market expected to reach USD 3.52 billion by the end of 2020."

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Adial Pharmaceuticals, Inc.