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:
- People who have a Zika infection might only receive mild symptoms that last just a few days, or no symptoms at all.
People infected with Zika virus may or may not develop symptoms, which are typically mild and can include red eyes, joint pain, rashes and fever and last for only a few days.2 People might ignore these signs and fail to get a proper diagnosis and take precautions that would reduce their chances of spreading the disease.
"Zika symptoms are also similar to dengue and chikungunya, which are tropical fevers transmitted by the same type of mosquito," said Hackett. This could cause misdiagnosis in areas where these viruses are more prevalent.3,4 Accurate tests are important to tell Zika apart from other viruses and provide a proper diagnosis.
- A bite from an infected mosquito isn't the only way you can develop a Zika infection.
Zika was originally thought to be spread solely by infected mosquito bites, but researchers are finding that is not the case. Pregnant women can transmit Zika to their fetuses during pregnancy, which can cause microcephaly and other brain defects. The virus can also be spread through sex, as reported in multiple countries, and passed on if the infected person does not present any symptoms at the time of transmission. Researchers are working to determine how long Zika stays in bodily fluids and other potential pregnancy complications.5
- Determining whether someone has a Zika infection is important to track and potentially prevent the spread of the virus – but testing for it can be tricky.
As mentioned previously, recognizing signs and symptoms of the Zika virus can be challenging, and diagnosing the virus can be equally as difficult. Molecular testing is recommended with urine in parallel with plasma or serum up to two weeks after a possible Zika infection.6 Tests consist of a visit to the doctor’s office, where a blood or urine sample is gathered and sent to a molecular laboratory.
- Zika is linked to serious health concerns, not just for pregnant women.
Some of the biggest concerns with the Zika virus involve pregnant women because it can cause microcephaly, a condition that is linked with babies being born with abnormally small heads and developmental issues. Recent scientific evidence also links the virus to Guillain-Barre syndrome and other neurological complications. Guillain-Barre syndrome affects the nervous systems and can cause temporary muscle weakness, paralysis, and even death.
"Studies show that reported instances of Guillain-Barre have increased in countries hit by Zika," says Hackett. "It's a very rare condition, but people who have traveled to a Zika-infected region and are experiencing tingling sensations in hands and feet should consult a doctor to be on the safe side."
- The fight against Zika is a worldwide, cross-team effort.
Researchers, scientists, doctors and governments have banded together to better understand the virus in hopes of containing the outbreaks. Specifically, the WHO set up an emergency committee in response to the Zika virus outbreaks, which is tasked with advising on the appropriate level of international concern and recommend measures to undertake in affected countries. The Centers for Disease Control and Prevention (CDC) also created a rapid response team, the CDC Emergency Response Teams (CERT), to bring expanded expertise to quickly contain the Zika outbreak. Members of the team are working to identify the problem, its cause and how to best communicate these findings with the public.
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:
1Situation 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.
2Lustig 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
3Murray 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
4Most 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
5Symptoms. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/zika/symptoms/symptoms.html
6Zika virus. World Health Organization. Website: http://www.who.int/mediacentre/factsheets/zika/en/
7Zika 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
8Transmission & Risks. Centers for Disease Control and Prevention. Website: http://www.cdc.gov/zika/transmission/index.html
9Guidance 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.
10From individuals meeting the Centers for Disease Control and Prevention (CDC) Zika virus clinical and/or CDC Zika virus epidemiological criteria.