Covaxx's COVID-19 antibody test receives US FDA emergency use clearance

Covaxx's diagnostic test for COVID-19 received emergency use authorization from the U.S. Food and Drug Administration.

The UBI SARS-CoV-2 ELISA antibody test can detect recent or prior infection with the coronavirus and can monitor the levels of antibody produced by vaccines.

Antibody tests are more capable of gauging the level of immunity in a population than RT-PCR diagnostic tests, which are commonly used to detect active infections.

The Hauppauge, N.Y.-based biotechnology company's test, which uses blood samples, has 100% specificity and sensitivity after 15 days of symptom onset in patients who have developed antibodies against the SARS-CoV-2 virus, according to Covaxx's Jan. 21 news release.

Covaxx, a unit of United Biomedical Inc., partnered with the University of Nebraska Medical Center in May 2020 to provide large-scale diagnostic testing and processing for organizations using the antibody test.

The company, which is also a vaccine developer, made an agreement with Aurobindo Pharma Ltd. in December 2020 to develop and commercialize its potential COVID-19 vaccine UB-612 for India and the United Nations Children's Fund.