EMERGING TESTS

Update on Zika-Fighting Diagnostics

Summer may be over but the fight against the mosquito-borne virus, Zika, continues in earnest. Locally-mosquito-transmitted cases in the United States have only occurred to date in Florida, but travel-related cases have been reported in all 50 states, with the most occurring in California, Florida and New York. As of Nov. 2, the CDC reports there is a total of 4,128 cases in the U.S. Of these, 3,988 are related to travel, 139 locally-acquired, and one laboratory-acquired.

Just as virus transmission has not abated, efforts to develop better diagnostics continue. The FDA has issued a total of 12 Emergency Use Authorizations for the following in-vitro diagnostics:

Zika Virus Detection by RT-PCR Test (ARUP Laboratories)
Sentosa® SA ZIKV RT-PCR Test (Vela Diagnostics USA, Inc.)
LightMix® Zika rRT-PCR Test (Roche Molecular Systems, Inc.)
ZIKV Detect™ IgM Capture ELISA (inBios International, Inc.)
xMAP® MultiFLEX™ Zika RNA Assay (Luminex Corporation)
VERSANT® Zika RNA 1.0 Assay (kPCR) Kit (Siemens Healthcare Diagnostics Inc.)
Viracor-IBT Laboratories, Inc.’s Zika Virus Real-time RT-PCR Test
Aptima® Zika Virus Assay (Hologic, Inc.)
RealStar® Zika Virus RT-PCR Kit U.S. (altona Diagnostics)
Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)
Zika MAC-ELISA (CDC)
Trioplex Real-time RT-PCR Assay (CDC)

Additionally, Oct. 21, the Centers for Disease Control and Prevention (CDC) announced approximately $70 million will be made available to state and local agencies to fight Zika. The funding comes through the agency’s Epidemiology and Laboratory Capacity for Infectious Diseases (ELC) Cooperative Agreement and will be used for surveillance and investigation, mosquito control and laboratory capacity.

For more detailed discussion of some of the new diagnostics granted EUA from the FDA, see the October 2016 issue of Diagnostic Testing & Emerging Technologies.

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