EKF Diagnostics, the global company in vitro diagnostics, announces that it has introduced one of the first tests to measure levels of COVID-19 neutralizing antibodies in individuals. Unlike other antibody tests, the Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit confirms both the presence and specific amounts of human IgG antibodies to the SARS-CoV-2 virus. This enables a wide range of COVID-19 applications, such as delivering critical knowledge to advance understanding of immune function, assessing vaccine response and accelerating therapeutic therapies.
Image credit: EKF Diagnostics
The high-quality qualitative COVID-SeroKlir device has obtained FDA Emergency Use Authorization (EUA) and is CE marked. It has demonstrated a sensitivity of 98.8% and a specificity of 99.6% for the detection of SARS-CoV-2 specific IgG antibodies against two SARS-CoV-2 virus antigens, its full-length spike protein and its receptor binding domain ( RBD). This proven accuracy means things are wrong and false negatives are reduced.
Being a two-step enzyme-linked immunosorbent assay (ELISA), ensures the accuracy of COVID-SeroKlir. The original ELISA screens are for positive or negative RBD samples, while the second plate provides a quantitative output of the titer / antibody density for the full-length spike protein. Because the hook uses standard methods and equipment, it is easy to operate without the need for scale equipment or specific environments and has parts 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 was tested on a very diverse group of more than 75,000 patients, including more than 30,000 COVID-19-tested; this is greater than any other COVID-19 test. In addition, the experiment was 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 showed that more than 90% of people with moderate-to-severe COVID-19 infection experience strong IgG responses against the viral spike protein [2]. In addition, these COVID-19 neutralizing antibody levels were confirmed to be relatively stable in the first five months after infection.
Explaining the value of knowing the exact levels of SARS-CoV-2 IgG antibodies, Julian Baines, Head of EKF, said, “Quantitative testing of IgG antibody can provide important support in determining health strategies public, informing health care decisions, and testing the effectiveness of vaccines when available. It is also an essential part of a general health check to detect past COVID-19 infections. This is because COVID-19 has been linked to an increased risk of potentially life-threatening complications, including lung, kidney and cardiovascular disease. ”
EKF has exclusive rights to the marketing and distribution of the Kantaro COVID-SeroKlir package in the UK and Germany, and non-exclusive rights in the rest of Europe. Julian Baines said,
“With the capacity to perform up to 10 million tests per month, EKF is well positioned to move COVID-SeroKlir high-speed machines to a wide range of laboratories for immediate operation without the need for specialized testing equipment.”
References
- Amant, F. et al. (2020). Serological assay to detect SARS-CoV-2 seroconversion in humans. Natural Medicine, 26 2033-1036 (2020)
- Wajnberg, A. et al. (2020). Strong neutral antibodies to SARS-CoV-2 infection persist for months. Science 10.1126 / science.abd7728 (2020)