INTENDED USE

Brucellosis is a debilitating disease of people caused by infection with one of a number of different Brucella species. In almost all cases, people acquire the infection through exposure to infected animals or contaminated animal products. Human brucellosis is well known for its wide range of symptoms, and is often clinically indistinguishable from other infectious diseases, such as malaria or typhoid.

Diagnosing the disease therefore typically relies on laboratory tests. The Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to Brucella in a whole blood, serum or plasma specimen in 10 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.

Pinciple

The Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is a one step immunochromatographic lateral flow assay. A lipopolysaccharide antigen (LPS) prepared from a culture of B. abortus is immobilized on the test region of the membrane. During testing, the specimen reacts with Protein A which conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient anti-Brucella antibody in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred. If the control line does not appear, the test result is not valid.