Expected use
The HAV IgG / IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of antibodies (IgG and IgM) against hepatitis A virus (HAV) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the diagnosis of HAV infection.
Summary and explanation
HAV, a positive sense RNA virus, is a unique member of the Picornaviridae family. HAV is highly contagious and is transmitted primarily from person to person by the fecal-oral route, either through person-to-person contact or by consuming contaminated food or water. Although hepatitis A is not normally a sexually transmitted disease, the rate of infection is high among men who have sex with men due to oral-anal contact. The presence of anti-HAV IgM in blood samples suggests an acute or recent HAV infection. In most infected people, the anti-HAV IgM titer rises rapidly over a period of 4 to 6 weeks after infection and then falls to undetectable levels within 3 to 6 months.
Anti-HAV IgG can be detected early in symptoms and remain elevated throughout a person's life. Protective immunity against HAV infection is indicated by an anti-HAV IgG level ≥ 20-33 mIU / ml, although the presence of anti-HAV IgG ≥ 20-33 mIU / ml does not necessarily guarantee protection against an future HAV infection. A patient without protective anti-HAV IgG levels (<20-33 mIU / ml) is considered at risk for HAV infection. The HAV IgG / IgM Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of anti-HAV IgG and IgM in serum, plasma or whole blood. It can be performed in 15 minutes by minimally qualified personnel without the use of laboratory equipment.
