EKF Diagnostics has introduced the Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit, one of the first tests to measure precisely levels of SARS-CoV-2 neutralising antibodies in individuals.
The Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit determines both the presence and specific quantities of human IgG antibodies to the SARS-CoV-2 virus. This enables a broad range of COVID-19 applications, such as delivering vital knowledge for advancing the understanding of protective immunity, assessing vaccine response and accelerating therapeutic treatments.
The high-performance quantitative COVID-SeroKlir kit has received FDA Emergency Use Authorisation (EUA) and is CE-marked. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2-specific IgG antibodies against two SARS-CoV-2 virus antigens, the full-length spike protein and its receptor-binding domain (RBD). This confirmed accuracy means false positives and false negatives are minimised.
Being a two-step enzyme-linked immunosorbent assay (ELISA) ensures COVID-SeroKlir’s accuracy. The ELISA’s initial plate screens for RBD-positive or -negative samples, whilrt the second plate provides a quantitative result of the antibody titre/concentration for the full-length spike protein. As the kit uses standard methods and equipment, it is easily operated without need for scaled equipment or special environments, and contains components to test 630 patient samples.
The assay is based on technology developed by clinicians at the Icahn School of Medicine at Mount Sinai Health System in New York, in partnership with RenalytixAI, a spinout company from EKF Diagnostics. Here, COVID-SeroKlir has been validated on a highly diverse cohort of more than 75,000 patients, including over 30,000 who were diagnosed with COVID-19; this is more than any other COVID-19 test.
The Mount Sinai study also demonstrated that over 90% of infected individuals with mild-to-moderate COVID-19 experience robust IgG antibody responses against the viral spike protein. In addition, these neutralising antibody levels were confirmed to be relatively stable during the first five months after infection.