FDA recently issued an emergency use authorization (EUA) to Altona Diagnostics, Hamburg, Germany, for the company’s RealStar Zika virus real-time reverse transcriptase polymerase chain reaction kit for the qualitative detection of RNA from Zika virus in persons meeting clinical or epidemiological criteria set by the US Centers for Disease Control and Prevention (CDC).

Capable of using either serum or urine specimens, the in vitro diagnostic (IVD) test can only be performed by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 to perform high complexity tests, or by similarly qualified non-US laboratories.

CDC’s Zika virus clinical criteria include clinical signs and symptoms associated with Zika virus infection, such as fever, rash, and arthralgia, which usually are mild and self-limiting. CDC’s Zika virus epidemiological criteria consider history of residence in or travel to a region with active Zika virus transmission at the time of travel.

In cases of suspected Zika virus infection, chikungunya and dengue virus infections must be ruled out, as these viruses are endemic to the same geographical regions and cause similar symptoms. A definite identification of the etiological agent causing symptoms is only possible with laboratory testing.

In addition to the company’s Zika virus test, launched with CE marking in January 2016, Altona Diagnostics also distributes CE marked real-time PCR test kits for the dengue and chikungunya viruses.

For more information, visit Altona Diagnostics.