QualiCodeTM Canine Lyme Disease Kit

Cambridge, MA, July 1997 -- Immunetics, Inc. is announcing the release of the QualiCode Canine Lyme Disease Kit. As part of a recent study, it has been found that this methodology unequivocally distinguishes between positive results due to infection versus vaccination. Dogs become infected with the spirochete Borrelia burgdorferi through the bite of an Ixodes tick. Subsequently the animal can develop fever, lymphadenopathy, arthralagia, and arthritis. The QualiCode Canine Lyme Disease Kit comes in two formats to detect either IgG or IgM antibodies to B. burgdorferi proteins present on the kit’s membrane.

The QualiCode methodology is a qualitative assay which has the sensitivity and specificity of a confirmatory test. To ensure complete utilization of its components, the QualiCode kit is designed to accommodate a variety of batch sizes (from 1 to 24 samples). Included in the kit are: 24 UPC test strips, all necessary reagents and controls to perform the immunoassay, and three 8-channel incubation trays. This assay can be performed in less than 1.5 hours and eliminates the need for costly repetitive testing by different methodologies.

The QualiCode Assay consists of three simple steps. Canine serum or plasma is diluted in sample buffer and added to the UPC test strip containing bands of specific proteins from B. burgdorferi. Specific antibody in the sample binds to these proteins. Enzyme-tagged antibody is then added and will bind to the antibody/protein complex. Added substrate reacts with the bound enzyme and the antibody/protein complexes appear as colored bands. The band pattern, like a bar code, is unique to a specific infectious organism. The UPC test strip can then be compared to the positive Reference Strip included with every kit for band identification. Positive and Negative Controls and a Record Sheet are also provided with each kit to simplify interpretation and documentation of the results.