Updated: Nov 4, 2020

In response to the global epidemic of COVID-19, United Biomedical, Inc. (UBI) and its

subsidiary COVAXX have developed UBI® SARS-CoV-2 ELISA, a serology test for

the detection of IgG antibodies against the novel coronavirus SARS-CoV-2.

UBI, an American company located in Hauppauge, NY, has tests available for use as a screening method both to detect infections and to control the spreading wave of infections in accordance with section IV(D) of the March 16, 2020 FDA guidance, “Policy for Diagnostic Tests for Coronavirus Disease-2019 During the Public Health Emergency.” Additionally, pursuant to Section 564 of the FD&C Act, UBI has submitted for Emergency Use Authorization (EUA) which is currently under review at the FDA. We have employed validation methodologies similar to those of our SARS test (SARS Antibody Test for Serosurveillance, Emerging Infectious Diseases September 2004: Vol 10, No. 9).

IgG antibody serology tests have the advantage of accurately and rapidly identifying not only infected patients, but also those previously exposed to the virus but not known to be infected, either because they never developed symptoms, or had been inaccurately diagnosed. These tests can be widely deployed in a large scale, cost-effective way.

Our UBI® SARS-CoV-2 ELISA pilot lot research use only (RUO) test kits have already been deployed to ground zero in Hubei, as well as to Shanghai, Beijing, Taiwan, the California State Reference laboratory, and other communities and labs in the U.S. for evaluation using blood samples from patients infected with COVID-19. Initial results have validated the specificity and sensitivity of our test kits for positively detecting SARS-CoV-2 reactive antibodies and, importantly, not cross-reacting with antibodies from patients infected with other coronaviruses (e.g., NL63 or HKU1). We are engaged in numerous large-scale screening studies; the large number of negative samples indicates excellent specificity >99%.

The UBI® SARS-CoV-2 ELISA serology test can quickly detect small levels of antibodies in human sera or plasma to determine if a patient has a SARS-CoV-2 infection post 10 days of onset. COVID-19 has a long asymptomatic incubation period, with some patients not displaying any signs or symptoms for weeks, if ever, after infection. Accordingly, some patients may not know that they have been infected with or exposed to SARS-CoV-2 during the incubation period, while remaining capable of spreading the virus.

COVAXX test summary
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COVAXX product insert
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