LYME WESTERN BLOT INTERPRETIVE SOFTWARE

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The development of software programs for the interpretation of Lyme Western Blots is proposed. The programs will analyze Western Blot band patterns scanned by a digital camera and interpret the test result as positive or negative. Two parallel, competing approaches will be taken: one based on statistical analysis of band data and the other on a neural network model. The statistical program will incorporate the CDC/ASTPHLD interpretive criteria for Lyme Western Blots, and will offer greater objectivity than a human interpreter. In contrast, the neural network program is capable of "learning" and improving its performance, and will develop its own criteria for interpretation through the analysis of large numbers of positive and negative samples. The neural network thus promises to surpass human accuracy in Lyme Western Blot interpretation, and provides a platform with which to develop interpretive capability for other diagnostic western blots. The program will be implemented on Immunetics' CodaVision(TM) analyzer, a fully automated instrument capable of performing 32 Western Blot assays in 30 minutes. This software program will resolve the issues of subjectivity, reader-to--reader inconsistency and interassay variability in the interpretation of Lyme Western Blots which have constrained their use as routine clinical tests. PROPOSED COMMERCIAL APPLICATIONS: The proposed software for interpretation of Lyme Western Blot tests will open this highly accurate technique to routine clinical laboratories which depend on automation to perform sophisticated tests. Offered together with Immunetics' CodaVision instrument, it will meet the growing demand for accurate Lyme disease testing. As the first such fully automated system on the market, it is anticipated that it will rapidly become the commercial standard for Lyme disease testing.