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EKF introduces accurate quantitative COVID-19 antibody test kit

EKF Diagnostics
15 Dec 2020
Meg Hicks
Student / Graduate

Product news

EKF Diagnostics, a global in vitro diagnostics company, has 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 therapeutic 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 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, 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. 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 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 specialized testing equipment.”

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AntibodiesAntibodies are used in techniques such as confocal and fluorescence microscopy, flow cytometry, ELISA, ELISPOT, immunohistochemistry, western blotting and immunopreciptation. Select specific antigen reactivity, high specific affinity, low non-specific binding, monoclonal or polyclonal, primary or secondary antibodies and associated conjugates such as an enzyme or dye for visualization.ELISAEnzyme-linked immunosorbent assays (ELISA), also known as enzyme immunoassays (EIA), are used for the detection and quantification of proteins, peptides and antibodies in a sample. ELISA often comes in kit format, with pre-selected antibody pairs to detect specific proteins or biomarkers of diseases such as diabetes and obesity, or cardiovascular and neurological disorders. Detection is made possible with chemiluminescent, fluorescent or colorimetric substrates and detection instruments such as microplate / ELISA readers. Other kits available include: Enzyme-linked immunospot (ELISPOT) assays for the quantification of protein-producing cells and chemiluminescent immunoassays (CLIA) kits. Find the best ELISA kits and products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Respiratory InfectionsRespiratory infections are caused by pathogens such as bacteria, viruses, and fungi, leading to diseases like pneumonia, tuberculosis, and COVID-19. It is important to identify respiratory infections quickly in patients to ensure appropriate treatment and care, and to prevent sepsis. Browse our peer-reviewed product directory to find the best tools for respiratory infection detection, compare products, check reviews, and get pricing directly from manufacturers.In Vitro DiagnosticsIn vitro diagnostics (IVD) involve testing samples outside the body, typically in a laboratory, to diagnose diseases or conditions. IVD technologies include blood tests, molecular assays, and other bodily fluid tests, enabling accurate diagnosis and monitoring of diseases. These tests are essential for guiding treatment decisions in clinical settings. Browse our peer-reviewed product directory to find the best IVD solutions; compare products, check reviews, and get pricing directly from manufacturers.Clinical StudyProspective biomedical or behavioral research studies on human subjects, following tests in animals, that are designed to answer specific questions about novel vaccines, drugs, treatments, dietary supplements, devices or new ways of using known interventions, generating safety and efficacy data.AntibodiesCovid-19COVID-19, caused by the SARS-CoV-2 virus, has led to a global health crisis with profound impacts on societies and economies. Research into diagnostics, vaccines, treatments, and understanding viral mechanisms continues to evolve. The pandemic has accelerated innovations in healthcare and biopharmaceuticals, including novel vaccine platforms and rapid testing technologies. Browse our peer-reviewed product directory to find top COVID-19 testing kits, research tools, vaccines, and treatments, compare products, read reviews, and receive direct pricing from manufacturers.Infectious DiseasesInfectious diseases are caused by pathogens such as bacteria, viruses, and fungi. Effective detection, prevention, and treatment are crucial to control outbreaks and improve public health. Diagnostic tools, vaccines, and antimicrobial treatments are essential components of managing these diseases. Research into emerging pathogens and resistance patterns continues to evolve. Browse our peer-reviewed product directory to find the best diagnostic tools, prevention solutions, and treatment options; compare products, read customer reviews, and get pricing directly from manufacturers.

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EKF introduces accurate quantitative COVID-19 antibody test kit