170 chapter 2 Table 31. Baseline characteristics of included studies investigating multi-gene Next Generation Sequencing panels histopathologic malignancy type reference country study design ntot ni included indeterminate cytology inclusion and exclusion criteria FNAC sample molecular technique PTC FVPTC FTC FTC-OV MTC mPTC other n.s. Nikiforov 2014 USA RS+PS 143 143 Bethesda IV TN; sufficient nucleic acids for molecular analysis; histological f/u available residual material from two FNAC passes ThyroSeq® v2 6 27 3 3 Le Mercier 2015 Belgium RS 34 34 indeterminate TN; sufficient nucleic acids for molecular analysis; histological f/u available cell blocks, or FNAC smears if DNA from cell block <10 ng AmpliSeq™ Cancer Hotspot Panel v2 1 2 3 1 Nikiforov 2015 USA PS 465 462 Bethesda III TN n.o.s. residual material from 1 or 2 FNAC passes ThyroSeq® v2.1 2 20 TOTAL 642 639 9 49 6 3 0 0 1 0 FTC: follicular thyroid carcinoma. FTC-OV: FTC, oncocytic variant (Hürthle cell carcinoma). FVPTC: papillary thyroid carcinoma, follicular variant. HCN: Hürthle cell neoplasm. mPTC: papillary thyroid microcarcinoma. MTC: medullary thyroid carcinoma. ni: total number of indeterminate thyroid nodules included in our analysis. n.s.: not specified. ntot: total number of thyroid nodules in study. PS: prospective. PTC: papillary thyroid carcinoma. RS: retrospective. TN: thyroid nodule. y: years. Table 32. Estimated pooled test performance of next generation sequencing in indeterminate thyroid nodules ni test + test - test ? nH (%) TP FP FN TN malignant (TP+FN/ni) sensitivity (95% CI), % specificity (95% CI), % Nikiforov 2014 143 42 101 0 143 (100%) 35 7 4 97 27% 90 (76-97) 93 (87-97) Le Mercier 2015 34 8 26 0 34 (100%) 5 3 2 24 21% 71 (29-96) 89 (71-98) Nikiforov 2015 462 31 431 0 95 (21%) 20 6 2 67 5% 71 (71-99) 92 (83-97) TOTAL 639 81 558 0 272 (43%) 60 16 8 188 10.6% 89 (82-97) 92 (89-96) FN: false negative. FP: false positive. LR+: positive likelihood ratio. LR-: negative likelihood ratio. nH: number of indeterminate thyroid nodules with conclusive index test and histopathological follow-up. ni: number of indeterminate thyroid nodules. test+: number of positive index tests. test-: number of negative index tests. test?: number of unknown or nondiagnostic index tests. TN: true negative. TP: true positive.
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