Application of CRISPR/Cas9-based mutant enrichment technique to improve the clinical sensitivity of plasma EGFR testing in patients with non-small cell lung cancer

Table 4 Analytical performance of assays for detecting T790M mutation based on clinical diagnosis

Method	T790M mutation was confirmed with multiple studies and or/and clinical diagnosis^*			Sensitivity (95% CI)	Specificity (95% CI)	Accuracy (95% CI)
Method	Results	Pos (n = 33)	Neg (n = 27)	Sensitivity (95% CI)	Specificity (95% CI)	Accuracy (95% CI)
ddPCR	Pos	16	1	48.5% (30.8%–66.5%)	96.3% (81.0%–99.9%)	70.0% (56.8%–81.2%)
ddPCR	Neg	17	26	48.5% (30.8%–66.5%)	96.3% (81.0%–99.9%)	70.0% (56.8%–81.2%)
CRISPR-CPPC assay	Pos	31	0	93.9% (79.8%–99.3%)	100.0% (87.2%–100.0%)	96.7% (88.5%–99.6%)
CRISPR-CPPC assay	Neg	2	27	93.9% (79.8%–99.3%)	100.0% (87.2%–100.0%)	96.7% (88.5%–99.6%)

Pos, positive; Neg, negative; CI, confidence interval; CRISPR-CPPC, CRISPR system combined with post-PCR cfDNA; ddPCR, droplet digital PCR; qPCR, real-time PCR; NGS, next-generation sequencing
^*T790M detected by more than two methods (qPCR from cfDNA, tissue or other types of samples, NGS, ddPCR, CRISPR-CPPC assay, Clinical diagnosis) simultaneously is considered “true positive”. “Clinical diagnosis-T790M-positive” was defined when clinical history and image interpretation supported that a positive T790M result would be close to a true positive. Image interpretation was performed only for CRISPR-CPPC-positive samples

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