FDA Emergency Use Authorization Reissued to Allow Fingerstick Blood Samples

GREENSBORO, NC — (September 30, 2020) — The US Food and Drug Administration (FDA) announced that it has authorized the first antibody test intended for use at point-of-care settings such as doctor’s offices, hospitals, pharmacies, urgent care centers and emergency rooms rather than having to be sent to a central lab. Carolina Liquid Chemistries, Corp. (CLC), a supplier of products for clinical diagnostics, drug screening, and COVID-19 testing, is the official distributor of this test, which is called the Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech. This test is now authorized for use with fingerstick whole blood specimens only at the point-of-care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

FDA Commissioner Stephen Hahn commented that authorizing point-of-care serology tests will enable “more timely and convenient results” for individuals who want to understand if they have previously been infected with the virus that causes COVID-19.

After months of guiding that tests intended for the point of care must be used in labs, the agency found this test met the standards to also be used with fingerstick whole blood specimens at point-of-care settings operating under CLIA Certificate of Waiver.

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 pathogen. 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:
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 a 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 at carolinachemistries.com/contact/.

CLC POC Fastep Press Release.00 SEP 2020