March 30, 2020—Hardy Diagnostics announced it is a U.S. supplier of the Anti-SARS-CoV-2 Rapid Test, developed by Autobio Diagnostics (Zhengzhou, China).
The test is an immunoassay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in plasma from anticoagulated human blood (heparin/EDTA/sodium citrate), serum, or capillary finger prick blood (no anticoagulants or additives) from individuals with signs and symptoms of infection who are suspected of COVID-19 infection. Testing is limited to certified laboratories able to perform highly complex tests in the laboratory. Turnaround time is 15 minutes.
“We are incredibly proud of the work our partners in China have accomplished,” Andre Hsiung, director of technical services at Hardy Diagnostics, said in a press release. “Because Autobio quickly developed this technology and because the FDA allowed emergency use authorization, we will be able to more effectively leverage our sales network to get this product out to where it is needed the most.”
The company’s Anti-SARS-CoV-2 Rapid Test web page includes a video providing further information about the test kit and also demonstrating the testing method. A link to the test kit interpretation guide is provided as well. Information on the company’s viral transport media can be found here.