This test, which will be marketed throughout the United States, can instantly detect antibodies in whole blood, serum, and plasma for SARS-CoV-2.
Webb Diagnostic Technologies announced today that they will begin marketing a point-of-care serology test for COVID-19. This test, which will be marketed throughout the United States, can instantly detect antibodies in whole blood, serum, and plasma for SARS-CoV-2.
According to the company, the test is designed to detect all human immunoglobulins, including IgG, IgM, and IgA. These immunoglobulins may indicate previous or current exposure to SARS-CoV-2. Rapid total antibody tests will be an important part of mitigating the spread of the virus and could play an important role as social distancing regulations are lifted.
Typically, serology tests use lateral flow technology that required special lab equipment and can take up to 25 minutes. This test will be disposable and will not require additional equipment. Additionally, the test will take 3 minutes from the point of blood draw until test completion.
“The utility of a test like this cannot be overstated. For hospitals and public health providers to be able to sort out who among their health care workers has the antibodies is a game changer,” William Schaffner, MD, professor of preventive medicine and health policy in the Division of Infectious Diseases at Vanderbilt University School of Medicine, said in the announcement. “Precautions and protections will still be required, of course, but the delivery of care becomes safer and more efficient — for patients and caregivers alike.”
The test was developed and validated using MedMira’s Rapid Vertical Flow Technology. This platform is US Food and Drug Administration-approved that has received regulatory approval in multiple countries. The platform has been used for more than a decade to test for other infectious diseases including HIV, hepatitis B and C, and syphilis. The coronavirus disease 2019 test will be manufactured in the United States and will be called REVEALCOVID-19.
According to the company, the new test can be produced easily and inexpensively. The company has already initiated filing for emergency use authorization from the US Food and Drug Administration. To date, no serological tests have received authorization for use outside of a laboratory setting.
“Dozens of new serological tests have been flooding the market but none yet check all the boxes in terms of accuracy, speed and ease of use outside a laboratory setting or without specialized equipment and personnel,” said Kevin Jones, PhD, chief technology officer of WebbDX said in a statement. “We knew we could build a better test. Working with our partners in academic medicine and government, we’re now able to bring to market a total antibody test that is not only fast and highly sensitive, but deployable in virtually any point of care.”