Table 3

Performance of the assay

Indeterminate (Bethesda III, IV,V)*Indeterminate (Bethesda III,IV)*Bethesda II and Bethesda VI*
Training†#Malignant1155940
#Benign14713726
Sensitivity86 [78–92]78 [65–88]96 [85–100]
Specificity75 [67–81]76 [68–83]82 [62–94]
Validation‡, entire set#Malignant61310
#Benign1281190
Sensitivity85 [74–93]74 [55–88]NA
Specificity72 [63–79]74 [65–82]NA
NPV91 [84–96]92 [84–96]NA
PPV59 [48–69]43 [29–57]NA
Validation‡, agreement set#Malignant40140
#Benign1101020
Sensitivity98 [87–100]100 [77–100]NA
Specificity78 [69–85]80 [71–88]NA
NPV99 [94–100]100 [96–100]NA
PPV62 [49–74]41 [25–59]NA
Evaluation study on Bethesda II/VI samples§#MalignantNANA9
#BenignNANA32
SensitivityNANA89 [52–100]
SpecificityNANA63 [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.