By Cole Petrochko, Staff Writer, MedPage Today
Published: June 22, 2010
WASHINGTON -- The FDA approved a new test for diagnosing the 2009 H1N1 flu virus developed by the CDC, replacing a test panel approved in April 2009.
The new test -- the CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD) -- isolates and amplifies any viral elements in a patient's upper or lower respiratory tract sample, which is then analyzed by a separate diagnostic device, in a process that takes around four hours, according to a prepared statement from the CDC.
The panel detects influenza A viruses -- specifically H1N1 -- which generate a fluorescent signal when amplified which is then read by the Applied Biosystems 7500 Fast DX Realtime PCR Instrument. The combined systems can handle multiple samples at once.
The older approved test panel -- the Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel) -- received emergency approval after undergoing development at a time when a limited number of H1N1 samples were available, the brief said.
The new test was optimized through a greater population size of H1N1 patients and can detect with 96% sensitivity and specificity upper respiratory samples of the virus.
The new test will be available in CDC-qualified laboratories.