On Mar. 31, 2020, BD (Becton, Dickinson and Company) and BioMedomics announced the release of a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. The new test, developed and manufactured by BioMedomics, was made available through BD and distributed exclusively by Henry Schein to health care providers throughout the U.S.

The test does not require special equipment and may be used in a laboratory or at the point of care. The test detects antibodies in the blood that are produced by the body in response to coronavirus infection. These antibodies are typically present in the middle to later stages of COVID-19 infection, but may remain present after exposure, which helps clinicians determine who has been exposed to the coronavirus, even if a person didn’t exhibit any symptoms of the COVID-19 disease.

Data on past exposure is important for researchers to more accurately understand the likely true occurrence of SARS-CoV-2 infection across a population. This information will be helpful in informing future strategies for combating COVID-19.

The test is completed in four, simple steps. First, blood is collected through normal blood collection devices such as the BD Microtainer^® Contact-Activated Lancet. A few drops of blood are then transferred to the test cartridge, followed by two to three drops of a buffer. The results can be read in 15 minutes, similar to how over-the-counter pregnancy tests show multiple lines for positive results and a single line for negative results.

The test analyzes blood, serum or plasma samples for the presence of immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies associated with the coronavirus (SARS-CoV-2). IgM provides the first line of defense during viral infections, followed by the generation of adaptive, high-affinity IgG responses for long-term immunity and immunological memory. The detection of COVID-19 IgM antibodies tends to indicate a recent exposure to COVID-19, and detection of COVID-19 IgG antibodies indicates a later stage of infection, so this combined antibody test could also provide information on the stage of the disease in patients.

Current guidance from the U.S. Food and Drug Administration (FDA) recommends that results from antibody testing should not be used as the sole basis to diagnose or exclude coronavirus infection. Depending on the clinical scenario, additional testing, such as those used on the BD MAX™ System may be considered to further evaluate the possibility of SARS-CoV-2 infection. The test has not been reviewed by the FDA but is permitted for distribution and use under the public health emergency guidance issued by FDA on March 16, 2020, and BD expects to begin shipping tests in April.

BD will have capacity to supply more than one million tests over the coming months, with the ability to scale up based on market demand and is working with medical products distribution company Henry Schein to make these tests available to medical care facilities throughout the United States. Health care providers can order the test and all collection devices needed to perform the test by contacting their BD or Henry Schein representatives.