Hardy Diagnostics’ COVID-19 Antibody Test Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 08 May 2020

Hardy Diagnostics (Santa Maria, CA, USA) has been granted Emergency Use Authorization by the US Food and Drug Administration for its Anti-SARS-CoV-2 Rapid Test.

The immunoassay intended specifically for determining the possibility of a COVID-19 infection was developed by Autobio Diagnostics Co., Ltd. (Zhengzhou, Henan, China), a microbiology medical device manufacturer. Hardy Diagnostics has entered into a strategic partnership with Autobio Diagnostics to become a US supplier of the new in vitro diagnostic medical device, Anti-SARS-CoV-2 Rapid Test.

Image: Hardy Diagnostics’ Anti-SARS-CoV-2 Rapid Test (Photo courtesy of Hardy Diagnostics)

The Anti-SARS-CoV-2 Rapid Test is a rapid, one-step lateral flow assay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in patients suspected of a COVID-19 infection. By using a patient’s finger prick blood, serum, or plasma specimen, the Anti-SARS-CoV-2 Rapid Test offers a turnaround time of only 15 minutes. The simple-to-use test requires no equipment or special expertise or training to implement. Through their partnership, Hardy Diagnostics and Autobio Diagnostics have begun opening up supply chains to deliver the rapid test to the US.