 | The Influenza A H1N1 (2009) Real-Time RT-PCR test is medically necessary and, therefore, covered for the diagnosis of H1N1 influenza virus in individuals with signs and symptoms of respiratory infection, in conjunction with clinical and epidemiological risk factors.
The Influenza A H1N1 (2009) Real-Time RT-PCR test is indicated to diagnose H1N1 influenza virus infection in individuals with signs and symptoms of respiratory infection, in conjunction with clinical and epidemiological risk factors. This test is being offered by the Company's participating laboratories.
Use the following code to report the Influenza A H1N1 (2009) Real-Time RT-PCR test:
87798: Infectious disease agent detection by nucleic acid (DNA or RNA), not otherwise specified; amplified probe technique, each organism
About H1N1 Influenza and the Influenza A H1N1 (2009) Real-Time RT-PCR test:
The H1N1 influenza virus is a flu virus of swine origin that first caused illness in Mexico and the United States in March 2009. According to the Centers for Disease Control and Prevention (CDC), the H1N1 influenza virus spreads in the same way that standard seasonal influenza viruses spread, mainly through the coughs and sneezes of individuals who are sick with the virus, but it also may be spread by touching infected objects and then touching the nose or mouth. The H1N1 influenza virus has been reported to cause a wide range of seasonal flu-like symptoms, including fever, cough, sore throat, body aches, headache, chills, and fatigue. In addition, individuals also have reported nausea, vomiting, and diarrhea. The World Health Organization (WHO) has declared the H1N1 influenza virus a pandemic as cases of infection have occurred in more than 70 countries.
On July 24, 2009, the US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to Focus Diagnostics, the infectious disease subsidiary of Quest Diagnostics, for its real-time polymerase chain reaction (PCR) test. The test, named Influenza A H1N1 (2009) Real-Time RT-PCR, is the first commercial laboratory test that has been granted EUA by the FDA to detect the H1N1 influenza virus during this pandemic emergency. It is also the first commercial laboratory test to qualitatively detect the RNA of the H1N1 influenza virus. The test uses polmerase chain reaction (PCR) to target two separate regions of the hemagglutiningene of the H1N1 influenza virus to differentiate the presence of seasonal human influenza A virus and the H1N1 influenza virus. The Influenza A H1N1 (2009) Real-Time RT-PCR is intended to be used on nasopharyngeal swabs, nasal swabs, throat swabs, and nasal aspirates from individuals with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The FDA advises that test results are typically available within 24 hours of receipt of a specimen by the laboratory.
EUA does not constitute FDA clearance or approval. Under the EUA, the FDA has only authorized the use of the Influenza A H1N1 (2009) Real-Time RT-PCR test for the duration of the declaration of emergency. The EUA will expire on April 26, 2010, unless it is terminated, revoked sooner, or renewed. As part of the EUA, Focus Diagnostics can now offer the test as a kit to other laboratories that are defined as Clinical Laboratory Improvement Amendments (CLIA) high complexity, providing they also run the necessary equipment and meet other requirements for performing the test.
If you have any questions, contact your Network Coordinator.
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