ZEUS Scientific has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its in vitro ELISA diagnostic test for identifying IgG antibodies to the SARS-CoV-2 virus in human serum and plasma. Currently, this test is in stock and is available to all clinical labs. The assay makes use of a dual antigen combination of recombinant S1 receptor-binding domain (RBD) viral protein and recombinant nucleoprotein in order to optimal performance.
Sonic Healthcare USA has introduced a multiplex RT-PCR assay that brings together testing for SARS-CoV-2 (COVID-19) and Influenza A/B with one specimen collection. This offering complements the firm’s current Covid-19 Testing Program that includes both RT-PCR and antibody testing.
20/20 BioResponse, a business unit of 20/20 GeneSystems , has begun accepting orders for the Assure COVID-19 IgG/IgM Rapid Test kits. These kits are claimed to be the first to receive EUA from the US FDA for point-of-care (POC) use with fingerstick blood samples on 23 September.
Abbott has revealed new interim clinical data results on its ID NOW COVID-19 rapid test, evaluated on a total of 1,003 people across both urgent care clinics and hospitals and nursing homes. According to the firm, the results confirm the data submitted to the US FDA in March for EUA and the interim results that was shared in May. The data also speak to the important role played by reliable point-of-care testing that is available in convenient and accessible locations where people can get immediate results.