The HAV IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of IgM antibodies to hepatitis A virus (HAV) in human serum, plasma or whole blood. It is intended to be used by professionals as a preliminary test result to aid in the diagnosis of infection with HAV.
Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care
providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.
The HAV IgG/IgM Combo Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Hepatitis A virus (HAV) in serum or plasma specimen.
HAV is a positive RNA virus, a unique member of picornavirdae. Its transmission depends primarily 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.
The HAV IgG/IgM Combo Rapid Test Cassette is to be used to detect IgG and IgM antibodies to HAV in less than 20 minutes by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
The test is base on a proprietary technology that combines the principles of immune-chromatography and fluid dynamics. The HAV IgG test has the recombinant mouse anti-human IgG immobilized on the membrane within the test zone. During the test the serum or plasma add on the sample port(S) reacts with mouse anti-human IgG on the membrane first. The HAV IgM test has the recombinant mouse anti-human IgM immobilized on the membrane within the test zone. During the test the serum or plasma add on the sample port(S) reacts with mouse anti-human IgM on the membrane first.
The buffer run upward from buffer well (B), HAV antigen reacts to particle coated with mouse anti-HAV migrates through the test zone, the HAV antigens are captured by the HAV antibody in the first step. It indicates positive result when the test zone form of a colored line, no colored line in the test zone indicates a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.