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.
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SOURCE Quest Diagnostics