NEW YORK – Abbott announced Tuesday its quantitative SARS-CoV-2 IgG II Quant antibody test received CE marking and can help evaluate someone's immune response to the virus.
The test runs on the firm's Architect and Alinity I systems and detects levels of IgG antibodies that attach to the virus' spike protein in serum and plasma. The test has nearly 100 percent specificity and 99 percent sensitivity in patients tested at least 15 days after symptoms began, the company said in a statement. It may also help determine whether someone has had a natural or vaccine-induced immune response, the firm added.
Abbott said it plans to submit the test to the US Food and Drug Administration for Emergency Use Authorization soon.
The company's first IgG test qualitatively detects the nucleocapsid protein of the SARS-CoV-2 virus and received EUA in April.