A COVID-19 antibody diagnostic developed through a joint venture between Mount Sinai Health System and RenalytixAI has been granted an emergency green light from the FDA.
The authorization for the New York-based Kantaro Biosciences provides a semi-quantitative blood test that measures the amounts of IgG antibodies—specifically ones that target the virus’s spike protein and its receptor-binding domain, and may slow the course of an infection.
The diagnostic previously received a CE Mark for the European market in October, and currently the developers aim to begin producing up to 10 million tests per month through a commercial partnership with Bio-Techne.
The COVID-SeroKlir test can be performed in any CLIA-certified laboratory and does not require additional equipment. Kantaro and its backers hope the diagnostic can help to assess the response of potential coronavirus vaccines in addition to aiding in everyday care.
"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City," said Sara Barrington, Kantaro's chief commercial officer. "It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust."
In testing of more than 80,000 samples, the two-step ELISA diagnostic delivered a false-negative rate of 1.2%, and a false-positive rate of 0.4%, according to the company. Additional data showed that most people diagnosed with COVID-19 maintained a robust immune system response for at least five months after infection. However, it has not been established exactly which antibodies at which levels are necessary for protective immunity.