FDA approves new high-performance antibody test
The U.S. Food and Drug Administration (FDA) issued emergency use authorization of a semi-quantitative antibody testing kit for the novel coronavirus (COVID-19) that is said to determine the presence and precise level of IgG antibodies, according to a recent announcement by test manufacturer, Kantaro Biosciences.
COVID-SeroKlir demonstrated 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2, the virus that causes the novel coronavirus, specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.
COVID-SeroKlir is a two-step enzyme-linked immunosorbent assay and can be used by any CLIA-certified laboratory without the need for proprietary equipment, according to the announcement.
Measuring IgG antibody levels 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, company representatives said in a statement. An increased risk of potentially life-threatening complications, including lung, kidney, and cardiovascular disease, has been linked to COVID-19.
"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,” said Sara Barrington, Kantaro's chief commercial officer, in the announcement.
Through a commercial partnership with Bio-Techne Corporation, the company said 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.