NEW YORK — InBios International said on Wednesday that it has received Emergency Use Authorization from the US Food and Drug Administration for its second SARS-CoV-2 antibody test.
The latest EUA is for the company's SCoV-2 Detect IgM ELISA kit, which is designed to qualitatively detect immunoglobulin M antibodies against SARS-CoV-2 in human serum. The kit includes all reagents and controls to run 90 test specimens with results available in about two hours. According to InBios, the test has demonstrated 92.5 percent sensitivity and 98.9 percent specificity in performance testing.
Earlier this month, Seattle, Washington-based InBios received EUA for an ELISA-based test kit for detecting immunoglobulin G antibodies against SARS-CoV-2. In April, the company was granted EUA for a RT-PCR-based test for the virus.