NEW YORK — Kantaro Biosciences said on Wednesday that its COVID-SeroKlir SARS-CoV-2 antibody test has received Emergency Use Authorization from the US Food and Drug Administration.
The ELISA-based test is designed to detect the presence and precise levels of immunoglobulin G (IgG) against SARS-CoV-2, making it useful for informing healthcare decisions and assessing patient responses to vaccines, Kantaro said. It has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2-specific IgG against two virus antigens: the full-length spike protein and its receptor-binding domain.
New York City-based Kantaro is a joint venture between the Mount Sinai Health System and RenalytixAI. In May, the company partnered with Bio-Techne on the scaled manufacture and distribution of the SARS-CoV-2 test.Â
"With this EUA in hand, we are ready to immediately supply this best-in-class serologic assay to clinicians across the US," Bio-Techne President and CEO Chuck Kummeth said in a statement. "Manufacturing will begin with a capacity of up to 10 million tests per month."
In October, Kantaro received CE marking for COVID-SeroKlir, which is being distributed in Europe through an alliance with EKF Diagnostics.