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H5N1 Antigen Bird Flu Rapid Tests
　
　 　
　
　
　

This kit is a chromatographic immunoassay for qualitative detection of hemagglutinin (HA) of Influenza Type-A viruses, H5 strain (also known as highly pathogenic avian influenza) in human body excretes, nasopharyngeal aspirates, chicken embryo whole virus inoculation or viral lysates, etc. It is intended for clinical identification of specific H5, type-A influenza viruses.

The use of this chromatographic immunoassay provides rapid reliable and safe diagnostic method for detection of H5 avian influenza within 30 minutes. Simple, single use device that has integrated quality control band and do not require any additional laboratory equipment.

 　
　
　    　
　
　 Avian influenza is an infectious disease of birds caused by type A strains of the influenza virus. The disease, first identified in Italy more than 100 years ago, now occurs worldwide. Infection triggers a wide spectrum of symptoms in birds, ranging from mild illness to a highly contagious and rapidly fatal disease resulting in severe epidemics. In the H5N1 bird flu in Hong Kong in 1997, patients had developed symptoms of fever, sore throat, cough, and, in several of the fatal cases, severe respiratory distress secondary to viral pneumonia. Previously healthy adults and children, and some with chronic medical conditions, were affected.

More recently, outbreaks of avian influenza H5N1 occurred among poultry in eight countries in Asia (Cambodia, China, Indonesia, Japan, Laos, South Korea, Thailand, and Vietnam) during late 2003 and early 2004. At that time, more than 100 million birds in the affected countries either died from the disease or were killed in order to try to control the outbreak. By March 2004, the outbreak was reported to be under control. Beginning in late June 2004, however, new deadly outbreaks of influenza H5N1 among poultry were reported by several countries in Asia (Cambodia, China, Indonesia, Malaysia [first-time reports], Thailand, and Vietnam). It is believed that these outbreaks are ongoing.

Human infections of avian influenza H5N1 however, have been reported in Cambodia (1case/1 death) Thailand (17cases/1 deaths) and Vietnam (51cases/ 33deaths) during both of these outbreak periods.

Hemagglutinin (HA) is a surface glycoprotein on Influenza A responsible for binding to N-AcetylNeuraminic Acid (NeuNAc) or commonly Sialic acid on host cell surface receptors. The Influenza viruses form the A virus group have principally similar morphological, chemical and biological features. The differentiation of the types is possible by the different antigenicity of their nucleo- and matrix proteins that have type-specific antigenicity. However, the essential immunodominant antigens and primary targets in diagnosis are the hemagglutinin (HA) and the neuraminidase (NA) antigens.

H5-HA(Ag) Rapid Test employs chromatographic lateral flow device with double antibody “sandwich” –like principle for detection of hemagglutinin (HA) of H5 influenza in sample. Colloidal gold conjugated monoclonal antibodies (anti-HA-Au) reactive to H5 HA, are dry-immobilized onto a nitrocellulose membrane cassette.
When the sample is added, it migrates by capillary diffusion trough the cassette rehydrating the gold conjugate. If present, HA will bind with anti-HA-Au forming particles. These particles will continue to migrate along the cassette until the Test Zone (T) where they are captured by monoclonal anti-HA antibodies previously immobilized there, and a visible red line will appear. If there is no H5 specific HA in sample, no red line will appear in the Test Zone (T). The anti-HA-Au will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat anti-mouse IgG antibodies aggregating in a red line, which indicates the validity of the test.