NEW YORK ─ Kantaro Biosciences on Monday said it has received CE marking for its COVID-SeroKlir and COVID-SeroIndex quantitative SARS-CoV-2 IgG antibody test kits, enabling their use in Europe and other regions that accept such designation.
COVID-SeroKlir is most useful in a clinical setting and COVID-SeroIndex is expected to be used for vaccine development or research, according to Kantaro, a joint venture between the Mount Sinai Health System and RenalytixAI, and a partner with Bio-Techne in the development of serology test kits for COVID-19.
The COVID-SeroKlir and COVID-SeroIndex antibody test kits detect the presence or absence of COVID-19 antibodies and measure the levels of antibodies leveraging two virus antigens ─ the full-length spike protein and its receptor-binding domain (RBD), which are correlated with antibody neutralization, Kantaro said.
The COVID-SeroKlir quantitative antibody test kit has demonstrated 97.8 percent sensitivity and 99.6 percent specificity, the firm added.
"Confirming past COVID-19 infection with specific numerical values helps patients to take control of their health and provides vital information for the clinician trying to understand the long-term impact of COVID-19 on other health issues such as cardiac, lung, and kidney health," Sara Barrington, Kantaro's chief commercial officer, said in a statement. "Additionally, knowing specific levels of neutralizing antibodies a person has produced is an important part of understanding immunity and supporting long-term public health strategies."
In May, Bio-Techne and Kantaro announced a partnership to initiate further development, scaled manufacturing, and distribution of a Mount Sinai-developed serology testing kit for SARS-CoV-2.
The technology for both kits was developed by Mount Sinai at the height of the COVID-19 pandemic in New York City.