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U.S. Sends India Vital Reagents to Test Avian Flu

March 3, 2006

NEW DELHI - In yet another step toward increased bilateral cooperation on health and science, the United States has provided India vital diagnostic reagents to allow rapid and accurate detection of the H5N1 Avian Influenza virus infection in humans, the U.S. Embassy announced today.

On February 27, 2006, the U.S. Embassy provided Real-Time Reverse Transcription--Polymerase Chain Reaction (RT-PCR) Primer and Probe Set diagnostic reagents from the U.S. Department of Health and Human Service's (HHS) Centers for Disease Control and Prevention (CDC) to the Indian Council of Medical Research (ICMR).
 
These reagents will allow rapid and accurate detection of H5N1 virus infection in humans. The reagents, which were shipped from Atlanta, will be sufficient to test 400 human specimens and are capable of producing results within 4 hours.

Earlier on February 3, 2006, the U.S. 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.

Testing with the FDA-cleared laboratory RT-PCR assay should be conducted in conjunction with other laboratory testing and clinical observations to help diagnose avian influenza in patients who might be infected with influenza A/H5 (Asian lineage) viruses and to provide epidemiologic information for surveillance purposes.
 
The test will also help to identify influenza A/H5 (Asian lineage) viruses in laboratory viral cultures. A definitive diagnosis of influenza A/H5 (Asian lineage), either directly from patient specimens or from a viral culture, might require additional laboratory testing and clinical and epidemiologic assessment in consultation with national influenza surveillance experts. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions.

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