22nd September 2021 Product update: rapidmicrobiology staff writer
SARS-CoV-2 Neutralizing Antibody Test is FDA-EUA and CE-Marked
EKF Diagnostics introduced one of the first tests to precisely measure levels of COVID-19 neutralizing antibodies in individuals.
Unlike other antibody tests, 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 treatments.
The high-performance quantitative COVID-SeroKlir kit has received FDA Emergency Use Authorization (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 minimized.
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, whilst 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 the need for scaled equipment or special environments and contains components to test 630 patient samples.
The best-in-class serologic COVID-19 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. In addition, the test has been independently verified by peer-reviewed journals, including Nature and Science 1, 2, as well as the U.S. National Institutes of Health (NIH).
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 2. In addition, these COVID-19 neutralizing antibody levels were confirmed to be relatively stable during the first five months after infection.
Explaining the value of knowing the precise levels of SARS-CoV-2 IgG antibodies, Julian Baines, CEO of EKF, said, “Quantitative IgG antibody testing can provide important support for determining public health strategies, informing healthcare decision making, and verifying the effectiveness of vaccines as they become available. It is also an essential component of a general health check to determine past COVID-19 infections. This is because COVID-19 has been linked with an increased risk of potentially life-threatening complications, including lung, kidney, and cardiovascular disease.”
EKF holds exclusive rights to market and distributes the Kantaro COVID-SeroKlir kit in the UK and Germany and non-exclusive rights in the rest of Europe. Julian Baines added, “With the capacity to manufacture up to 10 million tests per month, EKF is well placed to drive rapid availability of COVID-SeroKlir kits to a broad range of laboratories for immediate operation without needing specialized testing equipment.”
1. Amant, F. et al. (2020). A serological assay to detect SARS-CoV-2 seroconversion in humans. Nature Medicine, 26 2033-1036 (2020)
2. Wajnberg, A. et al. (2020). Robust neutralizing antibodies to SARS-CoV-2 infection persist for months. Science 10.1126/science.abd7728 (2020)
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Date Published: 22nd September 2021
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.