Figure 3.
Validation of RAPID-CRISPR assay using clinical samples. (A) Measurement of fluorescence using isoform-specific crRNA in APL cases (n = 66) and controls (n = 43) by RAPID-CRISPR. The result is represented as a median with an interquartile range; P < .0001. (B) Fluorescence data of bcr1, bcr2, and bcr3 isoforms of PML::RARA by RAPID-CRISPR. A median with an interquartile range represents the data P = ns (nonsignificant). (C) Fluorescence data of APL cases from the PB (n = 54) and BM (n = 12). The data are represented as a median with interquartile range; P = ns. (D) ROC curve to estimate the clinical sensitivity and specificity of the RAPID-CRISPR assay with APL (n = 66) and control (n = 43) cases. Area under the curve (AUC) = 1.000; 95% confidence interval (CI), 1.000-1.000. (E) Illustration of blinded validation of RAPID-CRISPR in APL (n = 9) and control (n = 9) cases. (F) ROC curve to estimate the clinical sensitivity and specificity of the RAPID-CRISPR assay in a blinded validation experiment. AUC = 1.000; 95% CI, 1.000-1.000. (G) Measurement of fluorescence between MRD− (n = 6) and MRD+ (n = 6) APL cases by RAPID-CRISPR assay. The data are represented as a median with interquartile range; P < .01. (H) LF-based readouts of RAPID-CRISPR assay for PML::RARA detection using 5 APL cases and 5 controls.

Validation of RAPID-CRISPR assay using clinical samples. (A) Measurement of fluorescence using isoform-specific crRNA in APL cases (n = 66) and controls (n = 43) by RAPID-CRISPR. The result is represented as a median with an interquartile range; P < .0001. (B) Fluorescence data of bcr1, bcr2, and bcr3 isoforms of PML::RARA by RAPID-CRISPR. A median with an interquartile range represents the data P = ns (nonsignificant). (C) Fluorescence data of APL cases from the PB (n = 54) and BM (n = 12). The data are represented as a median with interquartile range; P = ns. (D) ROC curve to estimate the clinical sensitivity and specificity of the RAPID-CRISPR assay with APL (n = 66) and control (n = 43) cases. Area under the curve (AUC) = 1.000; 95% confidence interval (CI), 1.000-1.000. (E) Illustration of blinded validation of RAPID-CRISPR in APL (n = 9) and control (n = 9) cases. (F) ROC curve to estimate the clinical sensitivity and specificity of the RAPID-CRISPR assay in a blinded validation experiment. AUC = 1.000; 95% CI, 1.000-1.000. (G) Measurement of fluorescence between MRD− (n = 6) and MRD+ (n = 6) APL cases by RAPID-CRISPR assay. The data are represented as a median with interquartile range; P < .01. (H) LF-based readouts of RAPID-CRISPR assay for PML::RARA detection using 5 APL cases and 5 controls.

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