Health Canada has authorised Kantaro Biosciences and its commercial partner Bio-Techne’s semi-quantitative SARS-CoV-2 IgG antibody test kit, COVID-SeroKlir, under the Covid-19 Interim Order.
COVID-SeroKlir is an enzyme-linked immunoassay that can be used in any clinical testing lab in Canada without requiring proprietary equipment.
It detects the presence and exact level of spike protein IgG antibodies.
These neutralising antibodies are either vaccine-generated or created as an immune response to exposure to the Covid-19 virus and could aid in averting infection or reinfection.
The core technology of the test was developed by the Mount Sinai Health System in New York, US, and was used on a diverse population of patients more than 127,000 times.
Kantaro Biosciences chief commercial officer Sara Barrington said: “COVID-SeroKlir delivers a numerical understanding of neutralising 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.”
With a sensitivity of 98.8% and specificity of 99.6%, the test deploys a two-step process to identify antibodies against two virus antigens – the full-length spike protein and its receptor-binding domain.
Kantaro noted that this accuracy makes the test highly precise with a reduced chance of false results.
Now available for distribution in Canada, the test is also authorised by the US Food and Drug Administration for emergency use and holds CE mark in the European Union.
Bio-Techne president and CEO Chuck Kummeth said: “We anticipate COVID-SeroKlir will be recognised quickly as an easily accessible, highly reliable and reproducible test, and are prepared to manufacture at scale.”
Last month, Bio-Techne partnered with Kantaro Biosciences, a joint venture of Mount Sinai Health System with Renalytix AI, to deliver Covid-19 antibody test kits.