The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, 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 at https://www.carolinachemistries.com/poc-fastep/
Carolina Liquid Chemistries also supplies Real-Time PCR instruments, extraction systems, and Emergency Use Authorized test kits for SARS-CoV-2, the virus that causes COVID-19, as well as sample collection and transportation supplies. COVID-19 test kits offered by Carolina Liquid Chemistries are for use in authorized laboratories only.
Refer to carolinachemistries.com for instructions for use, fact sheets, FDA EUA letters, clinical performance studies, and material safety data sheets.
About Carolina Liquid Chemistries Corp.
Headquartered in Greensboro, NC, Carolina Liquid Chemistries is an ISO 13485:2016 certified manufacturer, repackager/relabeler, distributor, and technical service provider of chemistry systems and reagents for clinical and toxicology laboratories, along with a variety of rapid test kits.
The company offers chemistry analyzers that range in throughput from 300 to 6,400 tests per hour and markets a wide menu of general chemistry, special chemistry, and toxicology reagents, along with affordable service contracts.
The company has responded to the COVID-19 pandemic by bringing a number of PCR and antibody tests to market under the FDA’s Emergency Use Authorization. For more information, visit carolinachemistries.com or email [email protected].