A new polymerase chain reaction (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. Upper respiratory specimens are easily obtainable in a doctor's office, and lower respiratory specimens are typically obtained from severely ill patients in a hospital setting.
Amplified viral genetic material generates a fluorescent signal, which is then detected and analyzed by a diagnostic instrument called the Applied Biosystems 7500 Fast DX Realtime PCR Instrument. The test panel and diagnostic system can provide results within four hours, and multiple samples can be tested at the same time.
The new test was developed by the [U.S.] Centers for Control and Prevention of Disease (CDC; Atlanta, GA, USA). It is called the "CDC Influenza 2009 A (H1N1) pdm Real-Time RT-PCR Panel (IVD)," and it 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 was authorized for use by the U.S. Food and Drug Administration.
The test will replace the previous real-time RT-PCR diagnostic test used during the 2009 H1N1 pandemic, called the "Swine Influenza Virus Real-time RT-PCR Detection Panel (rRT-PCR Swine Flu Panel)," which received an emergency use authorization by the U.S. Food and Health Administration (FDA; Silver Spring, MD, USA) 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 optimized using the vast amount of 2009 H1N1 genetic information CDC received throughout the pandemic.
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