Quest Diagnostics Introduces New COVID-19 Semi-quantitative Serology Test Service

Quest Diagnostics has introduced a new COVID-19 testing service that aids in providing insight into an individual's immune response as a result of a recent or prior infection with SARS-CoV-2, the virus that causes COVID-19, or to immune response observed in connection with COVID-19 vaccination.

As many as 40 percent of individuals infected with SARS-CoV-2 do not experience symptoms and may not realize they are or have been infected. Serology testing can inform if an individual's immune system has produced antibodies in response to infection, even in asymptomatic individuals, about two weeks following suspected infection. According to the U.S. Food and Drug Administration (FDA), serology tests can help to identify individuals who have "developed antibodies that may protect from future infection as well as identify those still at risk."

The new Quest Diagnostics test service provides a positive/negative result as well as a numerical result that may provide the basis for assessing relative changes in antibody blood levels. In addition, the new service can aid in assessing blood levels of antibodies produced to structural proteins of the SARS-CoV-2 spike protein. Because currently available vaccines in the United States contain mRNA that encodes the spike protein, the test may aid in indicating an immune response resulting from a recent or prior infection or vaccination. The test will not differentiate between immune response mounted in response to infection or vaccination.

"We believe that SARS CoV-2 semi-quantitative serology testing will be an important clinical tool to assess if an individual has mounted an immune response from recent or prior infection or from vaccination," said Jay G. Wohlgemuth M.D., Senior Vice President and Chief Medical Officer for Quest Diagnostics. "These insights may aid clinical management of certain patients at high risk of severe COVID-19 disease or who may be at risk for vaccination, such as people with a history of severe vaccine allergy or women who are pregnant. While the science is evolving, many individuals may have an interest in understanding their immune response status over time and post-vaccination."