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FDA Approves New, More Accurate Test to Detect H1N1 Virus ATLANTA -- June 23, 2010 -- A test developed by the Centers for Disease Control and Prevention (CDC) to diagnose human infections with the influenza A(H1N1) virus has been approved by the US Food and Drug Administration (FDA). The test, called the "CDC Influenza 2009 A (H1N1)pdm Real-Time RT-PCR Panel (IVD)," will help ensure the accuracy of influenza testing results among the different qualified laboratories that conduct influenza subtype testing in the United States and abroad. The test uses a molecular biology technique to detect influenza A viruses and specifically the H1N1 virus. The new test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic which received an emergency use authorisation by the FDA in April 2009. The earlier test was developed based on the limited number of 2009 H1N1 specimens available at the start of the 2009 H1N1 pandemic in April 2009. The new test has been optimised using the vast amount of 2009 H1N1 genetic information CDC received throughout the pandemic. As a result, the new PCR diagnostic test can detect human infections with 2009 H1N1 virus with sensitivity and specificity greater than 96% for upper respiratory specimens. The test is used to isolate and amplify viral genetic material present in secretions taken from a patient's upper or lower respiratory tract. The test panel and diagnostic system can provide results within four hours, and multiple samples can be tested at the same time. SOURCE: Centers for Disease Control and Prevention E-mail this page to a friend or colleague! To print, use this version