Kantaro Biosciences has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its semi-quantitative SARS-CoV-2 IgG antibody test kit.
COVID-SeroKlir is the semi-quantitative SARS-CoV-2 IgG antibody test kit developed to help determine the presence and accurate level of IgG antibodies. It is designed for use in a range of applications to fight against Covid-19.
The test kit is a two-step enzyme-linked immunosorbent assay (ELISA), is suitable for use in any CLIA-certified laboratory without the requirement of proprietary equipment.
According to the company, COVID-SeroKlir has showed 98.8% sensitivity and 99.6% specificity for identifying SARS-CoV-2 specific IgG antibodies against two virus antigens, including the full-length spike protein and its receptor-binding domain.
COVID-SeroKlir test already secured CE mark
In October this year, the company secured CE mark approval for the semi-quantitative SARS-CoV-2 IgG antibody test kit. It is currently available in 29 European countries.
The technology used in the COVID-SeroKlir test was developed by Mount Sinai. It has been used in a diverse population of more than 80,000 patient samples.
Through a commercial partnership with Bio-Techne, the test kits are being produced at scale with a capacity of up to 10 million tests per month.
Kantaro Biosciences chief commercial officer Sara Barrington said: “COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City.
“It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust. Having a numerical understanding of antibody levels can be especially powerful for patients, enabling them to take control of their health and enjoy some peace of mind during these uncertain times.”
Kantaro Biosciences, a joint venture between the Mount Sinai Health System and RenalytixAI, offers results-driven and reproducible diagnostic tests.
Earlier this month, GenScript USA secured FDA EUA status for its serology test to detect neutralising antibodies from recent or prior SARS-CoV-2 infection.
