One of first to detect both the presence and precise levels of COVID-19 neutralizing antibodies
Hospital Hub is delighted to share news of a brand new quantitative SARS-CoV-2 IgG antibody test kit from global in vitro diagnostics company EKF Diagnostics.
In what is one of the first tests to precisely measure levels of COVID-19 neutralizing antibodies in individuals, this is a huge, much-welcomed innovation in our battle against this deadly virus. 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. What this means is that it will support 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 COVID-SeroKlir test kit has received FDA Emergency Use Authorization (EUA) and is CE marked, thanks to its high performance and confirmed accuracy, demonstrating 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) – such accuracy means false positives and false negatives are minimized.
Being a two-step enzyme-linked immunosorbent assay (ELISA), ensures this 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. Even better news for clinicians and technicians is that 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.
Time and time again, science has literally made history during this pandemic and this ‘best-in-class’ serologic COVID-19 assay is yet another example of this; and it’s all thanks to 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 . In addition, these COVID-19 neutralizing antibody levels were confirmed to be relatively stable during the first five months after infection.
What this means is extraordinary, but we asked Julian Baines, CEO of EKF, to explain more about the value of knowing the precise levels of SARS-CoV-2 IgG antibodies and the difference it will make:
“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.”
Julian Baines concluded, “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.”
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.
EKF is a leading point-of-care diagnostics and central laboratory assay manufacturer with an estimated 80,000 hemoglobin, hematocrit, HbA1c, glucose and lactate analyzers in regular use across more than 100 countries. It specializes in developing tests for use in diabetes and anemia diagnosis and management, as well as providing a portfolio of reagents for use in clinical chemistry analyzers. EKF has also developed a portfolio of unique products that are helping clinicians with the fight against COVID-19.
Point-of-care diagnostics: EKF Diagnostics designs and manufactures world-class diagnostic devices, as well as distributing rapid test kits for infectious diseases and pregnancy. The EKF analyzer range is used widely in GP surgeries, pharmacies, blood banks, sports clinics, hospitals and laboratories for glucose, lactate, hemoglobin, hematocrit and HbA1c measurement.
Central laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents, as well as associated analyzers. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities.
COVID-19 testing: EKF has a unique range of leading COVID-19 testing products. Kantaro COVID-SeroKlir is a leading ELISA-based antibody test that provides a precise measurement of COVID-19 IgG antibodies. PrimeStore MTM is used as a transport media that allows the safe sampling, transportation and testing of swabs.
About Kantaro Biosciences – www.kantarobio.com
Kantaro Biosciences (“Kantaro”) is dedicated to ensuring that high-quality diagnostic tests for critical health challenges are accessible. The company provides rigorous, results-driven and reproducible diagnostics to advance the care and well-being of people, communities and society.
Kantaro specializes in the rapid scale-up of groundbreaking diagnostic innovations and the creation of partnerships to bring these crucial technologies to market. It is a joint venture between the Mount Sinai Health System, New York City’s largest academic medical system, and RenalytixAI, a developer of in vitro diagnostic solutions for kidney disease and a spinout company from EKF Diagnostics.