Challenges and Solutions in the Development and Validation of Molecular-Based Assays

Molecular-based assays have demonstrated a number of advantages over traditional culture-based approaches, including increased sensitivity and specificity, rapid turnaround time, multiplexing, reproducibility, and the ability to detect fastidious and unculturable organisms. While these assays have exhibited a number of benefits, great care must be taken to ensure that assays are properly validated to guarantee performance and uncompromised data. In the following white paper, we discuss the challenges associated with evaluating the analytical performance of a molecular-based assay as well as guidance on selecting the ideal reference materials that support this endeavor. (*Required fields)

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