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FDA Authorizes Abbott Zika Test for Use on Whole Blood Samples

NEW YORK (GenomeWeb) – Abbott announced today that the US Food and Drug Administration has expanded the Emergency Use Authorization for the company's RealTime Zika assay to now include use on whole blood samples.

The agency originally granted the assay EUA in November for use on human serum, EDTA plasma, and urine samples. Now, Abbott will also be able to use the test for detection of the Zika virus in whole blood, when collected alongside patient-matched serum or plasma samples.

The company said this is the first molecular test made by a commercial manufacturer authorized to detect Zika in whole blood samples. Research on the virus has suggested that it can be detected in whole blood for a longer period of time, up to two months, and at higher levels than in serum or urine. The FDA has said that Zika virus RNA is generally detectable in specimens during the acute phase of infection and up to around 14 days in serum and urine after symptoms arise.

The RealTime Zika RT-PCR assay isolates nucleic acids from a sample and purifies them using the Abbott mSample Preparation System operating on the Abbott m2000sp instrument or on another authorized instrument. Magnetic microparticle technology captures nucleic acids, and the system washes the particles to remove unbound sample components. Bound nucleic acids are then eluted and transferred to a 96 deep-well plate, and the purified nucleic acid is reverse transcribed into cDNA. This is then amplified in an instrument prior to target detection.

"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," John Hackett, divisional vice president of applied research and technology in Abbott's diagnostics products business, said in a statement. "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."