Development of a multiplex droplet digital PCR method for detection and monitoring of Mycobacterium tuberculosis and drug-resistant tuberculosis

Table 1 Analytical sensitivity and specificity of the quadruplex ddPCR assay evaluated using nine DNA samples, eight cultured MTB samples with known drug resistance phenotype, and 20 culture-negative samples

Drug	TP	FP	FN	TN	Sensitivity (%)^a	95% CI	Specificity (%)^a	95% CI
INH	14	0	1	22	93.33	68.05–99.83	100.00	84.56–100.00
RIF	15	0	0	22	100.00	78.20–100.00	100.00	84.56–100.00
EMB	5	1	2	29	71.43	29.04–96.33	96.67	82.78–99.92
FQ	3	2	0	32	100.00	29.24–100.00	94.12	80.32–99.28
SM	7	0	1	29	87.50	47.35–99.68	100.00	88.06–100.00

TP, true positive; FP, false positive; FN, false negative; TN, true negative
^a The nine DNA sample result was compared with the mutation profiles provided to us by the Korean National Tuberculosis Association while the eight cultured MTB sample result was compared with the phenotypic resistance result

ISSN: 1476-0711