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Abbott has received the CE mark for its new SARS-CoV-2 immunoglobulin G (IgG) quantitative laboratory serology test that can measure a person’s immune response.
The SARS-CoV-2 IgG II Quant Antibody Test can detect IgG antibodies that bind to virus spike protein on the virus surface in serum and plasma of individuals suspected of having or having Covid-19.
IgG antibody tests measure antibody levels and provide a quantitative result to help understand how a person is recovering from Covid-19.
In addition, the tests can be used to monitor a person’s immune response to vaccines and check a person’s antibody level to help analyze eligibility and potency for donations of convalescent plasma.
The test will be available on Abbott’s ARCHITECT and Alinity i platforms.
A study to analyze the clinical performance of the test on Abbott’s Alinity i instrument showed that the test had a specificity of 99.60% and a sensitivity of 99.35% in patients evaluated 15 days or more after symptoms began .
Divisional Vice President of Technology and Applied Research for Abbott’s diagnostics business, John Hackett, said: “Testing will continue to help both identify infected people and determine whether people have had a natural or vaccine-induced immune response.
“Quantitative antibody tests can help better understand a person’s immune response.”
The company intends to apply for emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for testing soon.
In addition to testing, Abbott has molecular, antigenic and serological tests in its Covid-19 test portfolio.
Testing can be done in the lab and at the point of care. They will allow health specialists to detect the virus at all stages of its life cycle.
In May, Abbott received USA from the FDA for its Covid-19 molecular test for use in its new Alinity i molecular laboratory system.
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