FDA Grants Authorization for Abbott Real Time ZIKA test using Whole Blood

Abbott announced that US FDA (Food and Drug Administration) has granted authorization for RealTime ZIKA test, to detect Zika virus in whole Blood 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.

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’s Divisional VP, John Hackett, Ph.D, said that 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. 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. There 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.

According to the WHO, Zika remains a significant enduring public health challenge. More than 4,800 people who live in the U.S. have been infected with Zika and more than 35,000 people are infected and reside in U.S. territories, mainly in Puerto Rico. Zika virus is primarily spread to people through bites from infected mosquitoes but can also be passed from pregnant women to their foetuse or through sexual transmission. 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.