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Dx Focus: Clinical and Regulatory PCR and Nucleic Acid Testing News: Feb 4, 2010


The US Food and Drug Administration has granted diagnostic developer ViraCor Laboratories an emergency-use authorization for its 2009 H1N1 influenza A real-time PCR test.

FDA granted the authorization in a Jan. 21 letter to Lee's Summit, Mo.-based ViraCor. The letter was made available ion the agency's web site this week.

"The scope of this authorization is limited to ViraCor Laboratories' use of the authorized ViraCor 2009 H1N1 Influenza A Real-time RT-PCR test for the diagnosis of 2009 H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection," the letter states.

ViraCor's test uses real-time reverse transcriptase PCR to qualitatively detection 2009 H1N1 influenza viral RNA in upper and lower respiratory tract specimens from patients with signs and symptoms of respiratory infection.

The testing procedure consists of nucleic acid extraction on the NucliSENS easyMAG system from BioMérieux followed by real-time RT-PCR on the Applied Biosystems 7500 Real-Time PCR System, according to the letter.

The Livestock Disease Diagnostic Center at the University of Kentucky now offers an H3N8 equine influenza assay to detect the virus in clinical specimens, UK said recently.

The news assay is based on real-time reverse transcription PCR, and is currently the most sensitive method to detect the H3N8 virus, also known as type 2 equine influenza virus, UK said.

The assay was recently developed and validated at UK's Maxwell H Gluck Equine Research Center and published in the Journal of Clinical Microbiology.

The cost of the new test per animal is $35 for in-state and $52.50 for out-of-state submissions, UK said.

Equine influenza is an acute, highly contagious viral respiratory disease of equids (horses, donkeys, mules, and zebras) caused by an infection with type A influenza virus. The virus spreads rapidly in susceptible horses and can result in high morbidity within 24 to 48 hours after the horse is exposed.

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