BioMerica's COVID-19 IgG/IgM Rapid Test receives CE Mark and provides results in 15 minutes.

Following a positive CE Mark, Biomerica Inc. recently announced it has commenced shipping initial samples of its COVID-19 IgG/IgM Rapid Test (a finger prick blood test with results in 15 minutes, that can be performed by trained professionals anywhere, eg, airports, schools, work, pharmacies and doctors’ offices, to countries outside the US). Evaluation test kits have been requested by Ministries of Health in multiple countries through the company’s distribution partners who are working with their government agencies to assess the tests and forecast demand. This disposable point-of-care serology test is different than the current polymerase chain reaction (PCR) tests in that initial studies indicate that serology tests can identify if someone has been exposed to the COVID-19 virus, and can further detect if a person was recently infected with the disease even if they have never shown or are no longer showing symptoms. This can help health agencies focus on prior contacts of persons previously infected. Existing PCR tests generally only show positive if a person is currently infected and the virus is still present. Furthermore, PCR tests require patient samples to be sent to a lab, thus increasing the cost of the test and reducing the speed to obtain a result. Biomerica’s test could also be used in conjunction with the PCR test by rapidly pre-screening larger groups of individuals, who if tested positive could be further tested using a PCR test for verification. Biomerica has begun the application process with the FDA under the COVID-19 Emergency Use Authorization (EUA), aimed at the possible clearance and eventual use of the test in the US. At this time, the product is not available for sale or use in the US. The portable test returns results in 15 minutes that reveal if a patient is infected with the SARS-CoV-2 coronavirus. Because it doesn’t require a medical laboratory, the test can be used in point-of-care setting.