Global in vitro diagnostics company EKF Diagnostics have announced it has introduced to market one of the first tests to precisely measure levels of Covid-19 neutralising antibodies in individuals.
Unlike other antibody tests, the company’s Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit determines both the presence and specific quantities of Covid-19 antibodies.
This allows for the gathering of a wide range of useful information, which can be used to further understand protective immunity to the virus, assess vaccine response and accelerate therapeutic treatments.
The COVID-SeroKlir test kit has already received FDA Emergency Use Authorisation (EUA) and is CE marked.
In testing, it showed to have 98.8% sensitivity and 99.6% specificity for detecting Covid-19 antibodies against two different strains of the virus antigens. This helps to minimise the risk of false positives and false negatives.
The test achieves this accuracy using a two-step process called an enzyme-linked immunosorbent assay (ELISA). In this process, the ELISA’s initial plate screens for one type of Covid-19 antigen, while the second plate provides a quantitative result checking against the second virus antigen type.
Using standard methods and equipment, the kit is also easily operated without need for scaled equipment or special environments, and contains components to test up to 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 in any other Covid-19 test), as part of a study at the Icahn School of Medicine at Mount Sinai Health System in New York.
The findings of this study were then independently verified by peer-reviewed journals and the US National Institutes of Health (NIH).
The Mount Sinai study demonstrated that over 90% of infected individuals with mild-to-moderate Covid-19 experience robust antibody responses against the viral spike protein – and 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 Covid-19 antibodies in people, 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.”