ABBOTT PARK, Ill., Feb. 2, 2017
/PRNewswire/ -- Abbott (NYSE: ABT) announced today that the
U.S. Food and Drug Administration (FDA) has authorized its
molecular test, the Abbott RealTime ZIKA test, to detect
Zika virus in whole blood (when collected alongside a
patient-matched serum or plasma sample) for emergency use. This is
the first molecular test made by a commercial manufacturer
authorized to detect Zika in whole blood samples, which is
significant since recent research suggests Zika virus can be
detected in whole blood for a longer period of time (up to two
months) and at higher levels versus testing with serum and urine
sample types.1,2,3
"Diagnosing a Zika infection can be challenging, especially
since people might not have any symptoms or only have mild symptoms
that last a few days," said John
Hackett, Ph.D., divisional vice president, applied research
and technology, Diagnostics Products, Abbott. "Abbott's molecular
test may provide the ability to identify the active virus over a
longer time period with whole blood and could provide a more
accurate diagnosis. Our test can also distinguish Zika from other
viruses such as dengue or chikungunya, which helps doctors make
informed diagnoses to help people get back to better health."
The Abbott RealTime ZIKA test is designed for use on the
m2000 RealTime System – the company's molecular
diagnostics instrument used in hospital and reference labs in the
U.S. and around the world. Providing results within five to seven
hours, the test is highly sensitive to detect if someone is
infected with Zika. It is also automated, allowing people who work
in the lab to be more efficient and spend less time preparing and
handling samples, reducing the chances of error and increasing
speed to diagnosis.
ABBOTT R&D EFFORTS RELATED TO ZIKA
Abbott has several additional R&D projects underway
(currently in development and not yet FDA approved, cleared or
authorized) to help address testing needs related to the current
Zika outbreak.
- Today's existing tools to detect Zika and other tropical
diseases are laboratory-based and require reliable power sources,
but often, testing is needed in remote areas where there are no
labs. To address this issue, the U.S. Defense Advanced Research
Projects Agency (DARPA) awarded a contract to Abbott to develop a
testing panel for Zika and multiple tropical fever pathogens for
use on a mobile platform to meet the needs of testing in rural and
remote areas.
- Another issue to address is the development of serology tests
that do not cross-react with other tropical disease
antibodies. Through a grant from the U.S. Agency for
International Development (USAID), Abbott is exploring the
development of a serology test to solve this challenge.
According to the World Health Organization, Zika remains a
significant enduring public health challenge.4 More than
4,800 people who live in the U.S. have been infected with Zika
(primarily from travel outside the U.S.), and more than 35,000
people are infected and reside in U.S. territories, mainly in
Puerto Rico.5 Zika
virus is primarily spread to people through bites from infected
mosquitoes but can also be passed from pregnant women to their
fetuses or through sexual transmission.6 It is important
to quickly and accurately determine whether someone has a Zika
infection to track and potentially help prevent the spread of the
virus. For more information, visit the CDC website at
http://www.cdc.gov/zika/.
ADDITIONAL DETAILS ABOUT ABBOTT'S EMERGENCY USE
AUTHORIZATION
The U.S. Food and Drug Administration (FDA) modified the EUA for
Abbott's RealTime ZIKA molecular test that can detect Zika
virus RNA in serum, plasma, whole blood (EDTA) and urine (whole
blood and urine collected alongside a patient-matched serum or
plasma specimen) from individuals meeting the Centers for Disease
Control and Prevention (CDC) Zika virus clinical and/or CDC Zika
virus epidemiological criteria. The Abbott Realtime ZIKA
assay has not been FDA-cleared or approved and is only authorized
for use for the duration of the declaration that circumstances
exist justifying the authorization of the emergency use of in
vitro diagnostic tests for detection of Zika virus or diagnosis
of Zika virus infection or both, unless the authorization is
terminated or revoked sooner. This test has been authorized
only for the detection of RNA from Zika virus and diagnosis of Zika
virus infection, not for any other viruses or pathogens.
About Abbott
At Abbott, we're committed to helping you live your best
possible life through the power of health. For more than 125 years,
we've brought new products and technologies to the world -- in
nutrition, diagnostics, medical devices and branded generic
pharmaceuticals -- that create more possibilities for more people
at all stages of life. Today, 94,000 of us are working to help
people live not just longer, but better, in the more than 150
countries we serve.
Connect with us at www.abbott.com, on Facebook at
www.facebook.com/Abbott and on Twitter @AbbottNews and
@AbbottGlobal.
1 Lustig Y, Mendelson E, Paran N, Melamed S, Schwartz
E. Detection of Zika virus RNA in whole blood of imported Zika
virus disease cases up to 2 months after symptom onset,
Israel, December 2015 to April
2016. Euro Surveill. 2016;21(26):pii=30269. DOI:
http://dx.doi.org/10.2807/1560-7917.ES.2016.21.26.30269
2 Murray KO, Gorchakov R, Carlson AR, Berry R, Lai L,
Natrajan M, et al. Prolonged Detection of Zika Virus in Vaginal
Secretions and Whole Blood. Emerg Infect Dis. 2017;23(1):99-101.
https://dx.doi.org/10.3201/eid2301.161394
3 Most Zika molecular tests currently available use
plasma, serum or urine samples only, except for the Centers for
Disease Control and Prevention's Trioplex Real-time RT-PCR assay,
which can also use whole blood.
http://www.fda.gov/downloads/MedicalDevices/Safety/EmergencySituations/UCM491592.pdf
4 World Health Organization Statement: Fifth meeting
at the Emergency Committee under the International Health
Regulations regarding microcephaly, other neurological disorders
and Zika virus. Website:
http://www.who.int/mediacentre/news/statements/2016/zika-fifth-ec/en/.
Accessed: January 10, 2017.
5 Case Counts in the U.S. Centers for Disease Control
and Prevention. Website: www.cdc.gov/zika/geo/united-states.html.
Accessed January 9, 2017.
6 Transmission & Risks. U.S Centers for Disease
Control and Prevention. Website:
https://www.cdc.gov/zika/transmission/index.html. Accessed
January 19, 2017.
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SOURCE Abbott