Intended Use
Human H5N1 IgM ELISA Kit is an indirect ELISA for the qualitative (-ve or +ve) or quantitative detection or measurement of IgM class of antibodies against H5N1 antigens in human serum and plasma. This kit is for research use only (RUO) and not for diagnosis, cure or prevention of the disease.
Storage
The microtiter well plate and all other reagents are stable at 2-8°C until the expiration date printed on the label. The whole kit stability is usually 6 months from the date of shipping under appropriate storage conditions. The unused portions of the standards should be stored at 2-8°C or stored frozen in small aliquots and should be stable for 3 months.
General Description
Influenza A virus subtype H5N1, also known as A(H5N1) or simply H5N1, is a subtype of the influenza A virus which can cause illness in humans and many other animal species. A bird-adapted strain of H5N1, called HPAI A(H5N1) for highly pathogenic avian influenza virus of type A of subtype H5N1, is the highly pathogenic causative agent of H5N1 flu, commonly known as avian influenza ("bird flu"). It is enzootic in many bird populations, especially in Southeast Asia. One strain of HPAI A(H5N1) is spreading globally after first appearing in Asia. It is epizootic (an epidemic in nonhumans) and panzootic (affecting animals of many species, especially over a wide area), killing tens of millions of birds and spurring the culling of hundreds of millions of others to stem its spread.
The influenza infection is an acute feverish virus infection, which principally leads to an illness of the respiratory tract and appears as an epidemic or pandemic. The infection mostly results from a droplet infection. The virus spreads from the mucous membrane of the upper respiratory to the whole bronchial tract. There the virus and its toxin can lead to a serious inflammation of the bronchial mucosa and a damage of the vessels. After incubation time of 1 to 3 days the symptoms appear suddenly: Followed by a fast increase of temperature, often accompanied by shivering, the catarrhal leading symptom appears, which contribute to the clinical course beside painful dry cough, tracheitis, laryngitis and frequently a rhinitis and conjunctivitis. The Influenza viruses form a virus group with principally similar morphological, chemical and biological features. The types A, B and C were defined, from which many other variants are known. The distinction of the types will be possible by the different antigenicity of their nucleoproteins, which are coated by a matrix protein with type-specific antigenicity, too. However, both internal antigens are of less importance for the immunity. The essential antigens are the hemagglutinin and the neuraminidase. Both are surface antigens and subject to a permanent change of their antigenicity, which is called drift or shift. The appearance of permanent new Influenza epidemics and pandemics are particularly facilitated by an antigen variability, because the new drift or shift variants infect a population which is only partly immune or in an extreme case completely susceptible to the disease. The determination of the Influenza type (A, B, and C) gives both the clinician and epidemiologist important indications for further actions.
Research has shown that a highly contagious strain of H5N1, one that might allow airborne transmission between mammals, can be reached in only a few mutations, raising concerns about a pandemic and bioterrorism. Several H5N1 vaccines have been developed and approved, and stockpiled by a number of countries, including the United States and other countries for use in an emergency.