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The need for accurate repeatable diagnostic assays and the pitfalls of testing anomalies: Case study examples from the seed industry
Scott Heuchelin: DuPont Pioneer
<div>Diagnostic assays are only as good as the rigor of the validation process. Too often the validation process prior to publication is limited and doesn’t always show the true limitations of the assay. These issues are often identified when the assay is used in different environs or geographies and false positives or false negatives are observed. These errors in diagnosis for phytosanitary certification can cause commercial or research seed to be rejected entry into a country where it is needed for research and development or to meet market needs. National Plant Protection Organizations (NPPOs) often employ diagnostic assays that they find published in science journals. When these assays are published without extensive inclusivity and exclusivity validation testing, problems often arise from related species or subspecies that exist in the given nation’s environs. Both false positives and false negatives can have major repercussions when the test is used for phytosanitary purposes. These direct losses of seed from impoundment, or the inability to get the seed to its destination due to assay error, can cost companies large sums of money or market competitiveness. Many of these issues could be avoided by better assay development and validation and international standardization of diagnostic assays for pathogen species or subspecies. This presentation will illustrate some of these issues and their resolution via real-world examples from the seed industry.</div>

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