COVAXX Covid-19 Antibody Test

WHO IS COVAXX?

COVAXX is a subsidiary of UBI Group. UBI Group was founded in 1985 and currently has over 5 operating entities and 950 employees globally. We have facilities in the United States, China, Taiwan, and Ireland. For the past three decades, we have developed, manufactured and sold HIV, HCV, HTLV and FMDV blood diagnostic kits worldwide through various distribution partners including Organon Teknika and BioMerieux. We have also developed, manufactured and sold over 4.5 billion vaccines and ~500 million doses annually through partners.

WHAT IS A COVID-19 ANTIBODY TEST AND WHAT DO THE RESULTS TELL ME?

When a person is infected by a virus, that person’s immune system produces antibodies specific to that virus to fight infection. A COVID-19 antibody test, using a small sample of blood, is able to detect the antibodies made by the body against the SARS-CoV-2 virus (the virus that causes the coronavirus disease), to diagnosis whether a person has (or previously had) COVID-19. The United Biomedical, Inc. (UBI) Group of Companies (UBI Group) has developed a COVID-19 antibody test that is called the UBI® SARS-CoV-2 ELISA.

HOW ACCURATE IS THE TEST?

The UBI SARS-CoV-2 ELISA is very accurate, highly specific and sensitive.

Validation tests conducted in California, Taiwan and China have demonstrated that the UBI® SARS-CoV-2 ELISA is highly sensitive, specific, and accurate. 100% of the blood samples collected post seroconversion of infection from patients who tested positive to COVID-19 by other methods were found to be positive using the UBI® SARS-CoV-2 ELISA. We have also tested over 900 blood samples that were collected before the present COVID-19 outbreak and none of these samples tested positive using our test, which means that our test has not produced even one false positive result. These samples included blood samples from patients who have previously tested positive for other human coronaviruses (e.g., NL63 or HKU-1) as well as other infectious diseases (e.g., HIV, HCV, and HBV).

WHAT ABOUT THE CURRENT RT-PCR TESTS BEING USED? HOW IS THIS DIFFERENT?

The need for large-scale testing has become apparent in the past weeks. While the RT-PCR nasal swab tests currently being used are helpful to test active infections, there are important limitations and restrictions. These include variability in accuracy with high false negatives (up to 50%), difficulty to scale up to test large populations of people, and the ability to only detect active infection but inability to determine if someone has been previously infected but recovered. As a result, the RT-PCR tests have been restricted in application, challenging to roll out, and unable to inform public health officials the true scope of outbreak.

In early March, the CDC finally called for use of antibody tests and the WHO urged all outbreak areas to immediately begin testing with such tests to better track and contain community spread of the virus. The UBI SARS-CoV-2 ELISA is the only high throughout antibody blood test currently on the market.