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