New Quantitative COVID-19 Test Kit for Precision Antibody Detection Introduced
Feb 01 2021 Read 582 Times
The Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test from EKF Diagnostics is one of the first to detect both the presence and precise levels of COVID-19 neutralising antibodies. Detecting specific quantities of human IgG antibodies to the SARS-CoV-2 virus enables superior understanding in many COVID -19 areas.
With FDA Emergency Use Authorization (EUA), this high performance CE marked quantitative COVID-SeroKlir kit 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.
COVID-seroKlir’s accuracy is ensured by a two-step enzyme-linked immunosorbent assay (ELISA). 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. Using standard methods and equipment, the kit is easily operated without need for scaled equipment or special environments. Each kit contains components to test 630 patient samples.
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; more than any other COVID-19 test during studies at the Icahn School of Medicine at Mount Sinai Health System in New York. The test has also been independently verified by peer reviewed journals, including Nature and Science [1, 2], as well as the US National Institutes of Health (NIH).
The 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 COVID-19 neutralising 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 distribute 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 specialised 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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