A new point-of-care diagnostic test that can confirm exposure to COVID-19 in just 15 minutes is being rolled out to healthcare providers in the US.
The test has been developed by clinical diagnostics company BioMedomics and is to be available through medical technology group Becton, Dickinson and Company (BD), and distributed by Henry Schein.
The test works by detecting antibodies in the blood that are produced by the body in response to coronavirus infection. Though these antibodies are usually present in the middle to later stages of COVID-19 infection, they may remain present after exposure. This gives clinicians the opportunity to determine whether people have been exposed to COVID-19, even if they are asymptomatic. Collating data on past exposure is important for researchers hoping to understand the true extent of COVID-19’s infection rate throughout the global population.
In particular, the test analyses blood, serum or plasma for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). With these antibodies being present in early and late stage infections, the combination test could potentially inform clinicians about the stage of the virus in patients. The FDA has stated that results from antibody testing should not be the sole basis to diagnose or exclude COVID-19 infection, and that additional testing may be required.
"Serology tests are important because they provide an additional piece of information to aid in characterising possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity," said Dave Hickey, president of Integrated Diagnostic Solutions for BD. "Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19. Our agreement with BioMedomics adds a rapid serology test that can augment current tests already on the market, and we are pleased to collaborate in this effort with Henry Schein, which has extensive knowledge of the point-of-care test field."
"BioMedomics designed the test to be easy to use and provide results in minutes, with no special equipment necessary or the need to transport the sample to a laboratory for analysis," said Frank Wang, CEO of BioMedomics. "Our test has been clinically validated at several hospitals and clinical laboratories in both the US and China, and our published clinical data in the Journal of Medical Virology was one of the world's first for a COVID-19 serology test. It has been used widely in China during the COVID-19 outbreak and is now ready to help combat coronavirus in the US through our collaboration with BD. We are committed to doing our part to battle this disease and are excited to have BD as a partner to help deliver our high-quality rapid test to those who need it most."
"We look forward to working with such an outstanding company as BD to help make the antibody test part of the standard of care," said Stanley M. Bergman, Henry Schein's chairman of the board and chief executive officer. "The test will help to identify people who have developed antibodies to the virus, which may inform future strategies regarding COVID-19."
The test is yet to be approved by the FDA but is permitted for distribution and use under the public health emergency guidance issued earlier this year. BD expects to being shipping the tests in April and states it has the capacity to supply over 1 million tests, with the ability to scale up If needed.
