Renalytix AI Plc (NASDAQ: RNLX) and Mount Sinai Health System’s joint venture, Kantaro Biosciences, LLC, has been granted a EUA from the FDA for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit. It is different from other test kits because it can discover the presence and exact level of IgG antibodies and has a wide variety of applications in the fight against COVID-19.
The basic technology of the test kit was created by Mount Sinai. It has been manufactured through the combined efforts of Kantaro & Bio-Techne Corporation at scale with a capacity of up to 10 million tests per month and the ability to scale up.
COVID-SeroKlir has exhibited 98.8% sensitivity and 99.6% specificity for identifying SARS-CoV-2 specific IgG antibodies against two virus antigens. It is a two-step enzyme-linked immunosorbent assay (ELISA) and can be used by any CLIA-certified laboratory without the requirement for exclusive equipment. The Kantaro test kit received the CE mark in October 2020 and is available in 29 countries in Europe.