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

Area of Science:

• Virology
• Molecular Biology
• Public Health

Background:

• Highly pathogenic avian influenza A/H5 virus (Asian lineage) poses a significant public health threat.
• Two distinct genetic lineages of influenza A/H5 viruses are known: Eurasian (Asian) and North American.
• Recent human infections in East Asia, Turkey, and Iraq highlight the need for rapid detection methods.

Purpose of the Study:

• To announce the clearance of a new diagnostic tool for Influenza A/H5 virus detection.
• To provide a reliable method for identifying the Asian lineage of highly pathogenic influenza A/H5.
• To support public health surveillance and response efforts for avian influenza.

Main Methods:

• Development of a Real-Time Reverse Transcription-Polymerase Chain Reaction (RT-PCR) primer and probe set by the CDC.
• Utilizing an inactivated virus as a positive RNA control for in vitro qualitative detection.
• FDA clearance of the diagnostic assay and control material.

Main Results:

• The FDA granted clearance for the Influenza A/H5 (Asian Lineage) Virus Real-Time RT-PCR Primer and Probe Set.
• The assay is designed for the qualitative detection of highly pathogenic influenza A/H5 virus (Asian lineage).
• The cleared test enables the identification of viruses associated with recent human infections.

Conclusions:

• The availability of this Real-Time RT-PCR test enhances the ability to detect and monitor the spread of the Asian lineage Influenza A/H5 virus.
• This diagnostic tool is crucial for public health laboratories responding to outbreaks of highly pathogenic avian influenza.
• The clearance signifies a step forward in managing and controlling H5N1 avian influenza in humans and animals.