HAV is a positive RNA virus, a unique member of picornavirdae1 . Its transmission depend sprimarily on serial transmission from person to person by the fecal-oral route. Although hepatitis A is not ordinarily a sexually transmitted disease, the infection rate is high among male homosexuals, as result of oral-anal contact 2,3 . The anti-HAV IgG is produced in the early stage of infection, its titer in serum or plasma has been quite high at the onset of serum and reach the peak after 2 ~ 3 months. The IgG antibody is a protective antibody and can be maintained for a long time. The emergence of anti-HAV IgG can’t make a HAV diagnosis unless anti-HAV IgM exist at the same time. The presence of anti-HAV IgG, but no anti-HAV IgM is a marker of infected HAV and acquired immunity. The presence of specific anti-HAV IgM in blood samples suggests acute or recent HAV infection 4-6 . The IgM antibody rapidly increases in titer over a period of 4-6 weeks post infection, and then declines to nondetectable levels within 3 to 6 months in most patients 7 . The HAV IgG/IgM Rapid Test Cassette is to be used to detect IgG/IgM anti-HAV in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
The HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) is a qualitative membranebased immunoassay for the detection of HAV antibodies in serum or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in IgG test line region. During testing, the specimen reacts with anti-HAV antibody particles in the test cassette. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in IgG test line region. If the specimen contains IgG antibodies to HAV, a colored line will appear in IgG test line region. In the IgM component, anti-human IgM is coated in IgM test line region. During testing, the specimen reacts with anti-human IgM.HAV IgM antibodies, if present in the specimen, reacts with the anti-human IgM and the anti-HAV antibody particles in the test cassette, and this complex is captured by the anti-human IgM, forming a colored line in IgM test line region. Therefore, if the specimen contains HAV IgG antibodies, a colored line will appear in IgG test line region. If the specimen contains HAV IgM antibodies, a colored line will appear in IgM test line region. If the specimen does not contain HAV antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that membrane wicking has occurred.
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.