4th June 2021 Product update: rapidvirology staff writer
Health Canada Approves FDA-EUA COVID-19 IgG Test for Spike Protein
Kantaro Biosciences, LLC, a joint venture between the Mount Sinai Health System and RenalytixAI and its commercial partner Bio-Techne Corporation have received Health Canada Authorization under the COVID-19 Interim Order for COVID-SeroKlir, its semi-quantitative SARS-CoV-2 IgG antibody test kit.
COVID-SeroKlir measures the presence and precise level of spike protein IgG antibodies. These are neutralizing antibodies produced as part of the immune response to COVID-19 virus exposure or generated by a vaccine and may help prevent (re-)infection. The Mount Sinai Health System in New York City developed the test’s underlying technology, which has been used over 127,000 times on a highly diverse patient population.
“We are pleased to bring the COVID-SeroKlir semi-quantitative antibody test kit to Canada,” said Sara Barrington, Kantaro’s chief commercial officer. “COVID-SeroKlir delivers a numerical understanding of neutralizing antibody levels — not just a yes or no qualitative result — in patients with a past infection as well as those that have been vaccinated. It is an important tool that can inform both individual healthcare decision making and public health policy while Canada reopens.”
“We anticipate COVID-SeroKlir will be recognized quickly as an easily accessible, highly reliable, and reproducible test, and are prepared to manufacture at scale,” said Chuck Kummeth, Bio-Techne’s president and chief executive officer.
COVID-SeroKlir has 98.8% sensitivity and 99.6% specificity resulting from a two-step process that detects antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. This precision makes the Kantaro test highly accurate, with a low potential for false results. COVID-SeroKlir is an enzyme-linked immunoassay (ELISA) that any clinical testing laboratory in Canada can use without the need for proprietary equipment. The test is available immediately for distribution.
COVID-SeroKlir has been authorized for emergency use by the U.S. Food and Drug Administration and received full CE mark authorization in the European Union.
*Available immediately and can be used in Canadian laboratories without proprietary equipment. Request information or click here to visit the website.
Date Published: 4th June 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.
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