FDA Allows Emergency Use of MERS-CoV Test Device

September 4, 2015

The FDA has issued an emergency use authorization for altona Diagnostics’ in vitro diagnostic test for the deadly Middle East respiratory syndrome coronovirus.

Authorization of the RealStar MERS-CoV RT-PCR kit follows a determination that the MERS virus presents a significant threat to U.S. citizens living in the affected regions.

The company describes the kit as a real-time reverse transcription polymerase chain reaction test to detect RNA in lower respiratory samples from patients with symptoms of MERS-CoV in conjunction with clinical and/or epidemiological risk factors.

Advertising for the RealStar kit must state that it has been authorized only for the detection of MERS-CoV and has not been FDA cleared or approved. It also must state that the test has been authorized for use by CLIA High Complexity Laboratories and similarly qualified non-U.S. laboratories.

The World Health Organization is monitoring outbreaks in South Korea and China as the virus spreads from the Middle East, where it was first identified in a Saudi Arabian patient in 2012. Egypt, Jordan, Kuwait, Lebanon, Oman, Tunisia, Qatar, United Arab Emirates and Yemen have reported laboratory-confirmed cases as well. More than a third of all MERS cases result in death. — John Bechtel