Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

Abbott Receives FDA Authorization for Blood Test to Detect Zika Virus



According to the company, this is the first commercial molecular test to be authorized by the US Food and Drug Administration (FDA) to detect Zika in whole blood samples.

Share this!

February 6, 2017 | by Sarah Hand, M.Sc.

Diagnostics maker Abbott, has announced that their RealTime Zika test has been approved to detect the virus in whole blood samples, for emergency use. According to the company, this is the first commercial molecular test to be authorized by the US Food and Drug Administration (FDA) to detect Zika in whole blood samples.

Compared to serum and urine samples, the Zika virus can be detected in whole blood samples for a longer time period as the pathogen remains in the blood at higher levels. One of the conditions of the authorization of Abbott’s Zika test is that the whole blood sample be collected from a patient alongside a serum or plasma sample.

“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 Dr. John Hackett, 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 RealTime Zika test is compatible with Abbott’s m2000 RealTime System, which is used as a molecular diagnostics instrument in hospitals and reference laboratories in the US and other countries. The test is highly sensitive and produces results in five to seven hours.

The diagnostic is also automated, making it less labor-intensive for laboratory staff. This automation also helps mitigate the risk of human error, and reduces the wait time for results.

While media coverage of the Zika virus outbreak has diminished, the World Health Organization (WHO) still believes that Zika is a major public health challenge. While the infection is often asymptomatic, it has been linked to serious birth defects, making it important that possible cases are diagnosed early.

Keywords: FDA, Zika Virus, Diagnostic


Share this with your colleagues!

Kite Pharma Secures FDA Approval for CAR-T Immunotherapy

October 20, 2017 - Kite Pharma’s Yescarta (axicabtagene ciloleucel) has become the second CAR-T immunotherapy to be approved in the US, with an indication in treating adult patients with relapsed or refractory large B-cell lymphoma.

Featured In: Biotech News

Fallopian Tubes Found to be Site of Origin for Most Ovarian Cancers

October 20, 2017 - This year, over 22,000 women will be diagnosed with ovarian cancer but a new study conducted by researchers at Perlmutter Cancer Center at NYU Langone Health suggests that most of these malignancies begin in another part of the reproductive system: the fallopian tubes.

Featured In: Life Science News

Food Companies are Looking for the Next Sriracha

October 19, 2017 - The Sriracha trend might be coming to an end and companies are looking for the next big hot sauce star to feature in their line-up.

Featured In: Food News


Five Reasons Why Toronto is Emerging as a Major Life Sciences Hub


Brexit – Separating Fact from Fiction

Evolving Best Practices for Working with Authors of Scientific Publications – Authorship and Beyond

Human Whole-Genome Sequencing in a New Era Defined by the Illumina® HiSeq X® and NovaSeq™ Platforms

Clinical Event Adjudication: Comprehensive and Efficient Dossier Review Using a Global On-Line Solution

Copyright © 2016-2017 Honeycomb Worldwide Inc.