Carolina Liquid Chemistries COVID-19 Antibody Test Receives FDA EUA for Use with Fingerstick Blood Samples at POC

The Fastep COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, Corp. (CLC, Greensboro, NC, USA), has been granted FDA Emergency Use Authorization (EUA) for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor's offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab.

The Fastep COVID-19 IgG/IgM Rapid Test Device was first authorized in July to detect antibodies against the virus in venous whole blood, serum, and plasma to help identify individuals with antibodies SARS-CoV-2 indicating recent or prior COVID-19 infection. In September, the 15-minute lateral flow test received authorization for point-of-care use using finger-stick blood samples. External controls are also available for the product. The test has been authorized only for the presence of IgM and IgG antibodies, against SARS-CoV-2, not for any other viruses or pathogen.