New laboratory assay for diagnostic testing of avian influenza A/H5 (Asian Lineage).

On February 3, 2006, the Food and Drug Administration (FDA) announced clearance of the Influenza A/H5 (Asian Lineage) Virus Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) Primer and Probe Set and inactivated virus as a source of positive RNA control for the in vitro qualitative detection of highly pathogenic influenza A/H5 virus (Asian lineage). Two genetic lineages of influenza A/H5 viruses exist: Eurasian (Asian) and North American. The primer and probe set, developed at CDC, is designed to detect highly pathogenic influenza A/H5 viruses from the Asian lineage associated with recent laboratory-confirmed infections of avian influenza in humans in east Asia and, most recently, in Turkey and Iraq.