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FDA clears Abbott's molecular test to detect Zika Virus in whole blood samples

Published 03 February 2017

The US Food and Drug Administration (FDA) has extended its emergency use authorization for Abbott's molecular test for the Zika virus for use with whole blood samples.

Previously, the FDA had authorised the test for detection in the samples of serum, plasma and urine only.

The test is being claimed as the first molecular test authorised to detect Zika virus in whole blood samples.

It has recently been discovered that Zika virus can be detected in whole blood for a longer periods of up two months and at higher levels, compared to testing with serum or urine samples.

the Abbott RealTime ZIKA test has been designed to be used on the m2000 RealTime System, Abbott’s molecular diagnostics instrument used in hospitals and laboratories around the world.

Abbott claims that the test is sensitive in detecting whether someone is infected with Zika virus and the results can be obtained within five to seven hours.

The testing instrument can also be automated, increasing the efficiency of lab staff by reducing their time spent preparing and handling samples, while also reducing the chances of error and speeding up the diagnosis process.

Abbott Diagnostics Products applied research and technology, divisional vice president John Hackett said: "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.

“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 World Health Organization (WHO) considers zika virus as a significant risk for public health. The virus spreads mainly through mosquito bites, but can also be passed from pregnant women to their foetuses and through sexual transmission.

In order to prevent the spread of the virus, it is important to quickly diagnose the infection.


Image: Abbott receives USFDA authorisation to detect Zika virus in whole blood samples. Photo: Courtesy of Abbott.