The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Versea Diagnostics, has received FDA Emergency Use Authorization 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.
This 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. On September 23rd, this 15-minute lateral flow test received authorization for point-of-care use using finger-stick blood samples. External controls are also available for this product.
This test has been authorized only for the presence of IgM and IgG antibodies, against SARS-CoV-2, not for any other viruses or pathogens. This test has not been FDA cleared or approved and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics or if revoked sooner.
Instructions for Use and Fast Facts for Healthcare Providers and Patients available HERE