EDP Biotech Corporation is a local small business whose mission is to develop and commercialize cost-effective blood tests to detect disease early. We operate a CLIA Certified laboratory (CLIA 44D2184836) and an ISO Certified Bio-Safety Level II facility right here in Knoxville. We work mainly with US manufacturers and have been developing early detection blood tests since 2005.
Bringing Testing to Tennessee
EDP Biotech will be performing ELISA serology (antibody) testing for IgG in the state of Tennessee as residents begin to go back to work and the economy reopens, and performing validations for other manufacturers to meet FDA EUA standards.
EDP Biotech recently notified and has been recently listed on the FDA website as a testing laboratory and manufacturer according to Section IV.D of the FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019.
Visit https://www.fda.gov for the full list.
Why should I get THIS antibody test?
This test offered at EDP Biotech uses “multiplexing” to combine two antibody tests into one for improved accuracy. It measures IgG, which are the lasting antibodies typically associated with immunity. This test may indicate that you currently have or were previously infected by the SARS-Cov-2 virus.
This test does not measure IgM. IgM are antibodies present typically during the early stages of infection, and may not be present in individuals who were exposed more than 1 week ago. IgM tests usually have a higher rate of false-positive results. This is not unique to COVID-19 and has been reported for other diseases.
Once reference material is available, this test is designed to give the actual level of antibodies (titer) detected rather than simply a Yes or No answer. This added detail will be much more meaningful for understanding immunity.