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What is this “new generation” of COVID antibody test?
On November 25, 2020, Mount Sinai along with Kantaro Biosciences received FDA approval for EUA for it’s new SARS-CoV-2 IgG antibody test kit called COVID-SeroKlir.
Sara Barrington, Kantaro’s Chief Commercial Officer said: “Mount Sinai technology 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. Measuring IgG antibody levels with COVID-SeroKlir can inform healthcare decision-making and public health strategies, as well as assess vaccine response.”
The FDA did caution that much remains unknown about the nature of COVID-19 neutralizing antibodies in humans and that a high level of antibodies does not necessarily guarantee immunity against the virus.
One possible scenario for the use of this test is in at risk populations where having a semi-quantitative antibody testing can be an essential component of a general health check to determine past COVID-19 infections.
As the US now begins it’s vaccine rollout, another use of this new test could be used to determine who already has high levels of neutralizing antibodies due to previous exposure and may not immediately need the vaccine. Mt. Sinai’s chief commercial innovation officer, Erik Lium, commented that the CDC and local public health officials will make decisions of how to allocate the limited doses, but “it may not be unreasonable to focus efforts on those who have no antibodies to COVID-19.”
Prerana Sangani, MD, December 8, 2020