Table 3.

Performance of the assay

		Indeterminate (Bethesda III, IV,V)*	Indeterminate (Bethesda III,IV)*	Bethesda II and Bethesda VI*
Training†	#Malignant	115	59	40
	#Benign	147	137	26
	Sensitivity	86 [78–92]	78 [65–88]	96 [85–100]
	Specificity	75 [67–81]	76 [68–83]	82 [62–94]
Validation‡, entire set	#Malignant	61	31	0
	#Benign	128	119	0
	Sensitivity	85 [74–93]	74 [55–88]	NA
	Specificity	72 [63–79]	74 [65–82]	NA
	NPV	91 [84–96]	92 [84–96]	NA
	PPV	59 [48–69]	43 [29–57]	NA
Validation‡, agreement set	#Malignant	40	14	0
	#Benign	110	102	0
	Sensitivity	98 [87–100]	100 [77–100]	NA
	Specificity	78 [69–85]	80 [71–88]	NA
	NPV	99 [94–100]	100 [96–100]	NA
	PPV	62 [49–74]	41 [25–59]	NA
Evaluation study on Bethesda II/VI samples§	#Malignant	NA	NA	9
	#Benign	NA	NA	32
	Sensitivity	NA	NA	89 [52–100]
	Specificity	NA	NA	63 [44–79]

*95% CIs are in square brackets.

†For training, estimates are based on the mean of 10 10-fold cross-validation runs. Samples with very low expression in any of the classification steps, as well as medullary samples, are not included.

‡Samples that failed quality control are not included.

§Additional blinded study.

NA, not applicable.