On Jun. 11, 2020, InBios announced that it had received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its SCoV-2 Detect IgG ELISA kit, which detects IgG antibodies to SARS-CoV-2 in human serum.

InBios’ COVID-19 antibody test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, the virus that causes COVID-19, which may indicate recent or prior infection. At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.

Antibody testing for COVID-19 is needed to understand the pervasiveness of the disease within communities. The SCoV-2 Detect IgG ELISA kit, which is available to order now, includes all reagents and controls required to run 90 test specimens with results in approximately 2 hours. No specific analyzer is required for this assay, making it versatile and suitable for many qualified laboratories. In performance studies, the kit demonstrates 97.8% sensitivity and 98.9% specificity. InBios has a record of success in bringing high-quality ELISA kits to the world market. In 2011, InBios was the first to be granted a 510(k) clearance from the FDA for its Dengue IgM ELISA kit and offered the first commercial Zika IgM ELISA under FDA’s EUA in 2016. The kits are well established and continue to support accurate diagnostic testing in the US and worldwide.