FDA Grants EUA to One of the First Tests That Measures Specific Levels of COVID-19 Neutralizing Antibodies

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first tests that measures specific levels of COVID-19 neutralizing antibodies.

COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit from Kantaro Biosciences, LLC (New York, NY, USA), a joint venture between the Mount Sinai Health System (New York, NY, USA) and Renalytix AI (New York, NY, USA), has been granted EUA by the FDA. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne Corporation (Minneapolis, MN, USA), the test kits are being manufactured at scale with a capacity of up to 10 million tests per month and the ability to scale up.

COVID-SeroKlir is a two-step enzyme-linked immunosorbent assay (ELISA) and can be used by any CLIA-certified laboratory without the need for proprietary equipment. Mount Sinai developed the underlying technology in COVID-SeroKlir, which has been used and validated in a highly diverse population of over 80,000 patient samples. COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. The Kantaro test kit received CE mark in October 2020 and is available in 29 countries in Europe.

Measuring IgG antibody levels with COVID-SeroKlir can inform healthcare decision-making and public health strategies, as well as assess vaccine response. Semi-quantitative antibody testing is also an essential component of a general health check to determine past COVID-19 infections. An increased risk of potentially life-threatening complications, including lung, kidney, and cardiovascular disease, has been linked to COVID-19.

"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City," said Sara Barrington, Kantaro's chief commercial officer. "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."

Related Links:
Kantaro Biosciences, LLC
Mount Sinai Health System
Renalytix AI
Bio-Techne Corporation