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.