New Test for Zika OKed

The US Food and Drug Administration gave emergency approval for a combination diagnostic that can distinguish between Zika, dengue, and chikungunya infections.

By | March 22, 2016

WIKIMEDIA, MADPRIMECurrent PCR-based Zika tests can’t rule out infections with dengue or chikungunya viruses—infections that cause similar symptoms and are also transmitted by Aedes mosquitoes. Last week (March 18), the US Food and Drug Administration (FDA) granted the US Centers for Disease Control and Prevention (CDC) approval to start using a three-in-one assay that screens for all three viruses simultaneously.

“This [emergency use authorization] will potentially allow CDC to more rapidly perform testing to detect acute Zika virus infection,” the CDC said in a statement.

The test won’t be available in hospitals or doctors offices, but will be used in a designated network of laboratories that assists in public health emergencies.

Last month, the FDA granted emergency use authorization (EUA) for these labs to use a diagnostic that can detect infections through antibodies in the patient’s blood weeks after the virus has been cleared. However, the test cannot rule out the possibility that a positive result was caused by dengue, and research labs and biotech firms are working to develop a more-specific antibody assay.

“As there are no commercially available diagnostic tests cleared or approved by the FDA for the detection of Zika virus infection, it was determined that an EUA is crucial to ensure timely access to a diagnostic tool,” the CDC said in a February 26 press release.

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