Influenza A, H1N1, Reassortant Vaccine Strain

Influenza virus is an enveloped, single stranded RNA virus with a segmented genome. Virions are spherical to pleomorphic or filamentous, 80-120nm diameter and 200-300nm long. Surface features are distinctive spikes primarily of the hemagglutinin interposed irregularly with clusters of the neuraminidase protein. Strains of influenza A are by convention described by geographic origin, strain number, year of isolation and hemagglutinin (H) and neuraminidase (N) sub-types. Influenza causes an acute viral disease of the upper respiratory tract characterized by fever, chills, headache, myalgia, weakness, runny nose and mild sore throat; cough can be severe; nausea and vomiting are uncommon; fatality is usually low, except in those with chronic lung or heart conditions.\n\nStrain:\nA/California/7/2009 NYMC X-179A (H1N1). This preparation contains a high concentration of viral antigens as well as some egg proteins (allantoic fluid).\n\nThis particular influenza strain is a reassortant virus that includes genetic components of the H1N1 influenza pandemic swine flu in a culture-adapted virus that has been selected for its qualities as a vaccine-producing strain. The live reassortant virus has passed safety testing in ferrets, in which it is attenuated for pathogenicity relative to wild-type A/California/4/2009 virus. Because A/California/4/2009 is identified as a variant strain of a pandemic virus, live derivatives must be handled under BSL2+ facilities and procedures.\n\nPreparation: \nEggs are infected by injection into the allantoic chamber, incubated for 72 hours, and refrigerated overnight prior to harvest. Allantoic fluids are harvested from the eggs and pooled.\n\nInactivation: Gamma radiation inactivation. \n\nApplications:\nSuitable for use in Serological studies of influenza A virus, immunogen for antibody production. Other applications have not been tested. A precipitate may form upon thawing, due to high product concentration. Dilute prior to clarification or other manipulation.\n\nTitre: Hemaglutination Endpoint Assay 7973 HA Units /ml\n\nProtein: 0.92mg/ml \n\nInactivation Assay: \nThe effectiveness of inactivation is shown when there is no detection of growth in two blind passages under standard cell culture conditions (MDCK cells). No live virus is detected by either CPE or HA Assay. Result: No growth detected\n\nStorage and Stability:\nStore this antigen preparation frozen at -70 degrees C to -100 degrees C. Repeated freezing and thawing should be avoided.\n\nHazards: We are aware of no specific hazards associated with this product. The reagent has been inactivated and should contain no infectious material. The viral strain used is an attenuated reassortant vaccine candidate strain of reduced pathogenicity relative to the wild type A/California/4/2009 virus, according to data published by the World Health Organization. Generally accepted good laboratory practices appropriate to biological reagents should be employed when handling this product.

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