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Abbott Molecular Receives EUA for Zika MDx

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted Emergency Use Authorization for Abbott's RealTime Zika assay, which detects Zika RNA in human serum, EDTA plasma, and urine.

In practice, 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, according to the FDA.

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 the m2000rt instrument, or in another authorized instrument, prior to target detection.

The FDA 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 Centers for Disease Control and Prevention noted that a positive RNA nucleic acid test result confirms that a patient has a Zika virus infection and no additional testing is indicated. Zika virus infection may still be present after a negative RNA nucleic acid test result, however, so serum should be analyzed by IgM antibody testing in these cases, CDC added.