Abstract:
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Traditional molecular diagnostics is concerned with the development and optimization of the assay or test that is used to detect, diagnose or monitor a pathogen (e.g., bacterium, virus or other organism that may cause disease). Statistical performance metrics for assay development and optimization include, for example, precision, linearity, accuracy, sensitivity/specificity or method comparison. At this time, no single publication exists that substantially unifies the statistical methodologies used in molecular diagnostics. The authors endeavor to present these methodologies with relevant applications.
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