Carolina Liquid Chemistries announced a distribution agreement for the Fastep COVID-19 IgG/IgM Rapid Test Device by Assure Tech, according to a press release.
The 15-minute test received a reissued emergency use authorization from the U.S. Food and Drug Administration (FDA) in September as the first serology (antibody) point-of-care (POC) test for COVID-19. Specifically, the EUA authorized the test for POCT for use with fingerstick blood samples.
The Assure COVID-19 IgG/IgM rapid test device was first authorized for emergency use by certain labs in July 2020 to help identify individuals with antibodies to SARS-CoV-2, indicating recent or prior COVID-19 infection. External controls are also available for this product.
