the first serology test authorized by the FDA through the EUA process
STAT now has the capability to perform the COVID antibody testing in-house using the Cellex antibody test. It was the first of the antibody tests to be authorized by the FDA through the Emergency Use Authorization process on April 1st. Due to the overwhelming demands of New York’s pandemic, supplies of Cellex have been constrained. But STAT is now one of the first in Texas to receive this most advanced point-of-care serology test.
The test requires only a blood draw, and the result is available in 30 mins. It looks for two types of antibodies, IgG and IgM which rise as the body mounts an immune reaction to fight off the SARS-COV2 virus. Consequently, this test looks for evidence of prior exposure to the virus. The result of this test should not be used to determine whether someone has an active COVID-19 infection. There is also uncertainty as to whether the development of antibodies to COVID-19 necessarily suggest long-term immunity. Nevertheless, it will be very helpful for individuals, as well as employers and public health officials, to determine whether they have been exposed to COVID-19 and have developed an immune response.