Pre-analytical processing typically involves multiple steps, including sample fixation, DNA isolation, and DNA quantitation. At each of these stages, even minor differences in e.g. operator to operator sample handling, instrumentation and methodology can introduce significant variation, calling into question the quality of DNA and the reliability of downstream assay results.
In response to this need, Horizon Diagnostics has developed a range of HDx™ FFPE Reference Standards to enable effective end-to-end process validation. Thereference standards are highly consistent and reliable, yielding near identical quantities of DNA, enabling users to compare extraction kits and control for batch to batch variation, as seen in the figure below.
H+E staining & DNA Extraction demonstrates the homogeneity and consistency of our FFPE technology
For each FFPE block we analyze DNA extraction from multiple sections and perform an Aperio® digital scan to verify cell numbers per section. The figure shows data from DNA extracted from 10 sections, each from 8 independent FFPE blocks, together with the corresponding H+E stains.
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