SECAUCUS, N.J., Sept. 30, 2020 /PRNewswire/ -- Healthcare
providers across the United States
can now access three different test options from Quest Diagnostics
(NYSE: DGX) to aid the diagnosis of COVID-19 and differentiate it
from other seasonal respiratory infections, including influenza
(flu).
Each test is designed to use a single specimen, promoting faster
test ordering, reporting and diagnosis, as compared to ordering
multiple tests, for potentially improved patient care. The tests
may also help reduce demand for specimen collection devices amid
supply constraints.
According to the Centers for Disease Control and Prevention,
this fall and winter could be one of the most complicated
times in the history of public health due to the potential
spread of seasonal respiratory viruses with the SARS-COV-2 virus
that causes COVID-19. Some symptoms of COVID-19 and seasonal
respiratory viruses, including flu, are similar, and diagnostic
testing can help determine the virus causing this
illness. Because of the COVID-19 pandemic, reducing the spread
of respiratory illnesses, like flu, this fall and winter is
more important than ever.
The new test options include the cobas® SARS-CoV-2 &
Influenza A/B*, an automated high throughput multiplex real-time
RT-PCR assay from Roche. The U.S. Food and Drug Administration
(FDA) granted Emergency Use Authorization (EUA) for the test
earlier this month. The test is intended for simultaneous
qualitative detection and differentiation of SARSCoV-2, the virus
that causes COVID-19, and/or influenza A or B virus RNA from
individuals suspected of respiratory viral infection consistent
with COVID-19 by their healthcare provider.
The test may be performed on healthcare
provider-collected nasal and nasopharyngeal swab
specimens and self-collected nasal swab specimens (collected in a
healthcare setting with instruction by a healthcare
provider). Nasal swabs include anterior nares swabs,
which involve collecting a specimen from the lower nostril.
Two additional test panels from Quest Diagnostics, the
Respiratory Viral Panel (RVP) test and the
Respiratory Pathogen Panel (RPP), now include testing for
SARS-CoV-2 using the company's SARS-CoV-2 RT-PCR test**, which was
granted FDA EUA in March 2020 to aid
the diagnosis of SARS-CoV-2*. With the addition of SARS-CoV-2, the
RVP panel can aid the identification of up to a dozen viruses and
subtypes and the RPP panel can aid the identification of 18 viral
targets and two bacterial targets. Each respiratory
panel test also only requires a
single nasopharyngeal specimen.
"With a perfect storm of COVID-19, influenza and seasonal
respiratory viruses circulating over the Fall and Winter months,
laboratory testing that can reliably identify the virus causing
disease will be critical to mobilizing effective patient care and
public health response," said Jay G. Wohlgemuth, M.D., Senior
Vice President and Chief Medical Officer, Quest Diagnostics. "Our
goal is to give providers multiple tools to care for patients as
quickly and effectively as possible, using a minimum of specimen
collection materials amid continuing supply constraints."
Patients suspected of having or confirmed to have active
SARS-CoV-2 infection or COVID-19 disease may not visit Quest
patient service centers, which are not equipped to collect the
necessary respiratory specimens for molecular SARS-CoV-2 diagnostic
testing. Patients who believe they may have COVID-19,
Influenza or other respiratory virus infections are strongly
encouraged to contact their healthcare provider.
*The cobas ® SARS-CoV-2 & Influenza A/B Test and the
Quest SARS-CoV-2 RT-PCR test ("Tests") have not been FDA
cleared or approved. The Tests have been authorized by the FDA
under an EUA for use by laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a,
to perform moderate and high complexity tests. The Roche test has
been authorized only for the detection of RNA from SARS-CoV-2
virus, Influenza A virus, and Influenza B virus and not any other
viruses or pathogens. The Roche test is only authorized for the
duration of the declaration that circumstances exist justifying the
authorized of the emergency use of in vitro diagnostics for
detection and differentiation of SARS-CoV-2 virus, Influenza A, and
Influenza B under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-
3(b)(1), unless the authorized is terminated or revoked
sooner.
**The Quest SARS-CoV-2 RT-PCR test has been authorized only for
the detection of nucleic acid from SARSCoV-2, not for any other
viruses or pathogens. The Quest test is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the
COVID-19 pandemic, working to broaden access to laboratory insights
to help us all lead healthier lives. We
provide both molecular diagnostic and
antibody serology tests to aid in the diagnosis
of COVID-19 and the immune response to the
virus. Our COVID-19 test services are based
on tests that have received FDA emergency use
authorization and which also meet our high standards
for quality. We are providing these test services under the
Public Readiness and Emergency Preparedness Act. We
provide data on COVID-19 testing to various
federal and state public health authorities, including the Centers
for Disease Control and Prevention, and participate in studies with
government and private
institutions, aiding COVID-19 public
health response and research. Through our team
of dedicated phlebotomists, air fleet team, couriers
and laboratory professionals, Quest Diagnostics works
hard every day to help patients and communities across the United States access quality COVID-19
testing.
For Media Statements about our COVID-19
Testing:
newsroom.questdiagnostics.com/COVIDTestingUpdates
For High Resolution Photos and B-Roll on COVID-19
Testing:
https://app.box.com/s/djpwi9bt8bwnaptdvvvtxkgotszvw0hp
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 47,000 employees understand that, in the right hands and
with the right context, our diagnostic insights can inspire actions
that transform lives. www.QuestDiagnostics.com
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SOURCE Quest Diagnostics