Zika virus carriers / REUTERS

U.S. FDA Authorizes Abbott to Perform Molecular Test to Detect Zika Virus

Abbott (No. 14 on the DiversityInc Top 50 Companies list) announced 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,” saidJohn 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.

Latest News

California and covid-19

California Commits To Distributing 40% of Its Existing Vaccine Doses To Underserved Communities

In an effort to help save lives of Black and Brown Californians who have been hit disproportionately hard by the COVID-19 pandemic, Governor Gavin Newsom has announced a new pledge to allocate up to 40% of existing vaccine doses to the state’s underserved communities. Health officials in the state hope…

Creighton head coach Greg McDermott

Creighton University Basketball Coach Greg McDermott Suspended Indefinitely for Insensitive Language

Unsurprisingly, the sports world continues to be a hotbed of latent racism and cultural insensitivity. The latest example: Creighton University basketball coach Greg McDermott. Following the loss of his team, the Bluejays (currently ranked 14th in the NCAA), McDermott urged his players to “stick together” and “stay on the plantation.”…

George Floyd Justice in Policing Act

US House of Representatives Again Passes George Floyd Justice in Policing Act; Bill Now Moves to Senate for Vote

On Wednesday, March 3, the U.S. House of Representatives approved the George Floyd Justice in Policing Act by a vote of 220-212. The vote comes nine months after Floyd, a 46-year-old Black man, was killed by Minneapolis police officers last spring. Clare Foran of CNN reported that “House Democrats originally…

New Jersey

New Jersey Becomes One of First States in the US to Require Diversity Education in Schools

Following a bill signed by Governor Phil Murphy, New Jersey schools are now required to incorporate diversity and inclusion lessons within academic lesson plans. The Associated Press has reported that the new bill “aims to promote and highlight diversity, including economic, gender, sexual orientation and race.” “The state’s education commissioner…