BioWatch PCR Assays Building Confidence, Ensuring Reliability: Abbreviated Version (2015) / Chapter Skim
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Executive Summary
Executive Summary
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The report discusses principles of performance standards, reviews information from several existing guidance documents and standards that might be applicable to BioWatch, and discusses assay testing efforts that have occurred or are ongoing. It provides recommendations on general principles and approaches for a performance standard and validation framework to meet BioWatch's mission.
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One fundamental aspect of assay validation for a system such as B ioWatch should be recognized and clearly communicated to program stakeholders -- BioWatch is designed to detect rare but high-consequence events and all assays will have some associated false positive and false negative rates. It is not practical in time, effort, or money to conduct laboratory-based assay performance testing using large enough numbers of replicates under enough different conditions to validate the assay's long-term false positive or false negative rate at the high levels of statistical confidence program users are likely to desire for operational decision making (e.g., to determine with statistical confidence that a false result will not occur more than once per x thousands or hundreds of thousands of samples)
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