Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test

What You Should Know:

– Abbott Receives CE Mark for its COVID-19 IgG Quantitative Antibody Blood Test that specifically detects levels of IgG antibodies that attach to the virus’ spike protein, which can be helpful to evaluate a person’s immune response to vaccines.

– Abbott plans to submit its test for the U.S. Food and Drug Administration (FDA) emergency use authorization soon.

Abbott, today
announced it received CE Mark for its new quantitative SARS-CoV-2 IgG
(Immunoglobulin G) lab-based serology test. IgG antibody testing that gives a
quantitative result (measuring the amount of antibodies) provides important
insights to people as they recover from COVID-19 and
helps evaluate a person’s immune response to a vaccine.

Why It Matters

Countries around the world are preparing for the
authorization and the distribution of COVID-19 vaccines. As these vaccines
become available, healthcare professionals and researchers will need to assess
how individuals and communities are responding.

The quantitative IgG antibody test is the latest in Abbott’s
broad portfolio of tests to support the global healthcare community in the
fight against COVID-19. Abbott’s COVID-19 test portfolio includes molecular,
antigen and serology tests. These tests can help healthcare professionals
detect the virus at all stages of its life cycle, including tests that are done
in the lab as well as rapid tests done at the point of care.

SARS-CoV-2 IgG II Quant Antibody Test

Abbott’s quantitative IgG antibody test is designed to
detect levels of IgG antibodies that attach to the virus’ spike protein on the
virus surface in serum and plasma from individuals who are suspected to have
had COVID-19, or in serum and plasma of subjects that may have been infected by
SARS-CoV-2.

A study to determine the clinical performance of Abbott’s
SARS-CoV-2 IgG II Quant test on its Alinity i instrument found it had 99.60%
specificity (ability to exclude false positives) and 99.35% sensitivity
(ability to exclude false negatives) in patients tested 15 days or more after
symptoms began.

Availability

The quantitative IgG test will be available on both the
Abbott ARCHITECT and Alinity i platforms. Abbott is also developing a test and
plans to submit for U.S. Food and Drug Administration (FDA) emergency use
authorization soon.

“Testing will continue to help both identify those who are infected as well as determine whether people have had a natural or vaccine-induced immune response,” said John Hackett, Ph.D., divisional vice president of Applied Research and Technology for Abbott’s diagnostics business. “Quantitative antibody testing can help provide greater understanding of a person’s immune response.”

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