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14. METHOD COMPARISON RESULTS
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The results of the method comparison studies are summarized in Tables 2 and 3 below. For
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all sample types and enrichment methods tested, the updated BAX® System method
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returned results that were identical to the certified method. POD analysis demonstrates no
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statistically significant difference between results of the updated BAX® System method and
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the reference culture methods.
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Fluorescent Probe Performance
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Performance of the fluorescent probes in the additional eight cycles do not appear to suffer
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either by photo bleaching, which would lead to decreased signal for a positive reaction, or by
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quencher degradation, which would lead to a false positive rise in signal. Thousands of reactions
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have been run internally to date in the algorithm training and validation phases of the modified
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protocol. Examples of typical reactions are shown below in Figure 1 (negative reactions) and
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Figure 2 (positive reactions). Data in these figures is typical of data obtained during algorithm
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training. Additional data is available upon request.
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Dupont BAX Salmonella PTM Report
Modification Approved 2012 / PTM Certification No. 081201
For Expert Review Panel Use Only
Do Not Distribute