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

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Feb 24, 2021, 07:30 ET

SECAUCUS, N.J., Feb. 24, 2021 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX), the world's leading provider of diagnostic information services, today 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, 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."

"Importantly, we also believe semi-quantitative testing will improve public health surveillance as researchers across the United States seek to better understand the contributions of vaccination and prior infections on herd immunity," Dr. Wohlgemuth added.

In its commitment to advancing COVID-19 science and public health response, Quest Diagnostics currently provides COVID-19 semi-qualitative antibody testing services and variant genomic sequencing services to aid public health monitoring by the Centers for Disease Control and Prevention.

The new semi-quantitative testing service is the latest addition to the company's existing menu of COVID-19 qualitative IgG and IgG/IgM test services. These services aid in identifying a relative level of adaptive immune response to recent or prior infection with SARS-CoV-2. The Quest Diagnostics menu of serology testing services are based on several FDA emergency use authorized tests from leading manufacturers.*

While there is no recommended minimum interval between infection and vaccination, current evidence suggests that the risk of SARS-CoV-2 reinfection is low in the first few months after initial infection but may increase with time due to waning immunity. Based on available science, it is unclear how long an individual will sustain an effective immune response to SARS-CoV-2 following infection or vaccination. However, research of other coronaviruses, including SARS, and the low rate of known SARS-CoV-2 re-infections, suggests those with antibodies may be at lower risk of symptomatic infection. A study recently published in the New England Journal of Medicine found no symptomatic infections in individuals with antibodies to SARS-CoV-2 over six months.** Another study suggests COVID-19 antibodies may remain stable for more than 8 months.***

According to the CDC, vaccination should be offered to persons regardless of history of prior symptomatic or asymptomatic SARS-CoV-2 infection. The CDC also advises that while vaccine supply remains limited, persons with recent documented acute SARS-CoV-2 infection may choose to temporarily delay vaccination up to 90 days, if desired, recognizing that the risk of reinfection, and therefore the need for vaccination, might increase with time following initial infection. Pre-vaccination testing can help tell whether antibodies are present in an individual patient regardless of the cause of their presence.

Ordering a Test

Serology testing employs a blood specimen. Quest Diagnostics operates more than 2,200 patient service centers across the United States that perform blood draws for COVID-19 antibody testing consistent with health and safety guidelines from the Centers for Disease Control and Prevention (CDC). Healthcare providers can also collect blood specimens in their offices for patients for testing by Quest Diagnostics. For more information on visiting our patient service centers, refer more about our Peace of Mind program.

Only a healthcare provider can order a Quest Diagnostics serology antibody test. Assuming a provider places an order for testing, patients may schedule appointments ahead of time through the Quest Diagnostics MyQuest patient portal or at www.QuestDiagnostics.com.

*These tests have not been reviewed by the FDA. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. The test system being used by Quest Diagnostics to perform the testing has been granted Emergency Use Authorization by the FDA.

**N Engl J Med 2021;384:533-40. DOI: 10.1056/NEJMoa2034545

***J. M. Dan et al., Science 10.1126/science.abf4063 (2021)

About COVID-19 Testing at Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. For more information about the latest developments with our COVID-19 testing, visit: newsroom.questdiagnostics.com/COVIDTestingUpdates

About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world's largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com  Follow us on LinkedIn, Twitter, Facebook and Instagram.

SOURCE Quest Diagnostics