In the past several months, you've likely heard a lot about the Zika virus, a mosquito-borne virus that's grown into a household name since late 2015 when Brazil reported an uptick in Zika cases – just as the country was gearing up to host the Rio 2016 Olympic Games. Today, a number of organizations, including Abbott, are working in hopes to address the current outbreak with the goal to help protect and improve the health of people around the world.
According to the World Health Organization (WHO), Zika virus cases have been reported in more than 70 countries, spanning the Pacific Islands, Africa, Asia and the Americas.1 To help address testing needs related to the current outbreak, Abbott’s new molecular test to detect Zika virus – the Abbott RealTime ZIKA test – received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This is the first test 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.2,3,4
Abbott's goal with the test is to help clinicians make informed diagnoses for people infected with the virus. The test is another example of Abbott’s ongoing commitment to public health emergencies and our long legacy of developing innovative diagnostics that help people live longer and healthier lives.
IMAGE SOURCE: World Health Organization (WHO); click to enlarge.
With insight from John Hackett, Ph.D., divisional vice president of applied research and technology for Abbott's Diagnostics business, here are five things you might not know about Zika:
About Abbott's Emergency Use Authorization
Abbott's RealTime ZIKA test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use by authorized laboratories. The test has been authorized to 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) and can provide results within five to seven hours. 10
The test is highly sensitive, meaning that it can detect if people have an active Zika infection. 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 contamination and increasing speed to diagnosis.
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.
Check out the resource below to learn more about Abbott’s Zika test:
1. Situation Report: Zika Virus, Microcephaly, Guillain-Barre Syndrome. World Health Organization. Website: http://apps.who.int/iris/bitstream/10665/250633/1/zikasitrep27Oct16-eng.pdf?ua=1.
2. 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
3. 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
4. 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
5. Symptoms. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/zika/symptoms/symptoms.html
6. Zika virus. World Health Organization. Website: http://www.who.int/mediacentre/factsheets/zika/en/
7. Zika virus infection & Zika fever: Frequently asked questions. Pan American Health Organization and World Health Organization. Website: http://www.paho.org/hq/index.php?option=com_content&view=article&id=9183:2015-preguntas-frecuentes-virus-fiebre-zika
8. Transmission & Risks. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/zika/transmission/index.html
9. Guidance for U.S. Laboratories Testing for Zika Virus Infection. Centers for Disease Control and Prevention. Website: https://www.cdc.gov/zika/laboratories/lab-guidance.html. Accessed: September 13, 2016.
10. From individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical and/or CDC Zika virus epidemiological criteria.
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