Researchers at TGen and Northern Arizona University (NAU) have developed a real-time PCR assay for detecting H1N1 influenza strains (which may also be known as as "novel H1N1," "swine flu," and "Mexican flu," among others) in a sample and informing clinicians whether the detected strain is a variant resistant to antiviral drugs, such as oseltamivir and other neuraminidase inhibitors. By quickly providing clinicians with accurate detection and susceptibility information, an effective treatment strategy can be chosen for a patient or population.
H1N1 is a dominant strain of influenza in the United States and throughout the world. As with other influenza strains, H1N1 can be expected to show resistance to anti-viral drugs over time, thus necessitating the development of new treatments to respond to pandemics. While tests exist for detecting H1N1, such tests are generally conducted by state and federal health agencies for patients who require hospitalization or appear at high risk because of a suppressed immune system or diagnosis of a chronic disease, and are not available in doctor’s offices. Additionally, only the US Center for Disease Control and Prevention (CDC) and a few select labs previously could test for antiviral drug resistance in detected H1N1 strains, and such tests use time intensive technology.
This real-time PCR assay developed by TGen and NAU uses a molecular technique to rapidly make exact copies of specific components of the H1N1 virus’s genetic material, and is available for use in a clinician’s office or by a commercial testing service. Using the copied genetic material allows the test to distinguish H1N1 strains from other circulating human influenza or historic swine influenza strains, as well as detect genetic mutations, such as an H274Y mutation in the neuraminidase gene, which indicate antiviral drug resistance.
Link to US Issued Patent US 8,808,993 B2