Figure 1.
Sensitivity and precision of the IGHV leader-based NGS assay. (A) The probability of detection of the clonal IGH target in contrived MRD samples as a function of malignant cell-equivalent input. The y axis signifies detection (0, no; 1, yes), and the x axis signifies the MRD depth of the sample on the malignant cell-equivalent scale. A logistic regression model is fit to the data to estimate the limit of detection, defined as a probability of detection of ≥95%. (B) The percentage coefficient of variance (%CV) as a function of malignant cell-equivalent input. Data points represent the %CV from ≥3 replicate measurements on contrived MRD samples. The limit of quantitation (defined at 70%CV) is estimated using a Sadler precision profile, detailed above the graph.