Analytical validation of a circulating tumor DNA assay using PhasED-Seq technology for detecting residual disease in B-cell malignancies (IMAGE)
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Figure 1: Limiting dilution series linearity. The measured PVAF for each replicate at each target PVAF dilution level created from the LoD clinical-contrived sample are plotted (black filled circles). Blue filled circles are the averages of the replicates at each target PVAF. The targeted PVAFs were calculated by using the average of the measured PVAF replicates for the highest dilution level and then using the dilution factors performed in study execution. For example, if a 1:2 dilution was performed, the new target PVAF is expected to be half of the previous dilution’s target PVAF. The dotted line represents a slope of 1 (i.e., x = y) and is shown for visualization. Figure shows test performance is as expected, i.e. when a 1:2 dilution is performed during study execution the measured PVAF also reflects this dilution.
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