190 chapter 2 Table 41. Estimated pooled performance of Afirma® GEC in cytology suspicious for a Hürthle cell neoplasm reference n SHCN test + test - test ? nH (%) TP FP FN TN malignant (TP+FN/ni) sensitivity (95% CI), % specificity (95% CI), % LR+ (95% CI) LR- (95% CI) Alexander 2012 31 26 5 31 (100%) 9 17 1 4 32% 90 (55-100) 19 (5-42) 1.11 (0.83-1.49) 0.52 (0.07-4.11) Harrell 2014 21 19 2 17 (81%) 7 10 0 0 33% 100 (59-100) 0 (0-31) 0.98 (0.79-1.22) 1.38 (0.03-62.25) Lastra 2014 25 17 8 15 (60%) 2 11 0 2 8% 100 (16-100) 15 (2-45) 1.01 (0.58-1.78) 0.93 (0.06-14.87) McIver 2014 17 12R 1R 4 13 (100%) 2 10 0 1 12% 100 (16-100) 9 (0-41) 0.95 (0.55-1.65) 1.33 (0.07-25.22) Brauner 2015 72 45 26 1 46 (65%) 6 37 0 3 8% 100 (54-100) 8 (2-20) 1.02 (0.81-1.27) 0.84 (0.05-14.50) Celik 2015 6 6 0 6 (100%) 1 5 0 0 17% 100 (3-100) 0 (0-52) 0.82 (0.35-1.89) 3.00 (0.08-107.45) Noureldine 2015 25 25 0 20 (80%) 4 16 0 0 16% 100 (40-100) 0 (0-21) 0.93 (0.68-1.26) 3.40 (0.08-150.62) Yang 2016 12R 11R 1R 12 (100%) 4 7 0 1 33% 100 (40-100) 13 (0-53) 1.08 (0.71-1.63) 0.60 (0.03-12.15) POOLED RESULTS 209 161R 43R 5 160 (78.4%) 35 113 1 11 17.2% 98.4 (38.6-100) 8.3 (3.9-16.7) 1.07 (0.99-1.16) 0.19 (0.00-14.77) 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 available histopathology. ni : number of included indeterminate nodules. R: includes only the reported number, a (unknown) number of thyroid nodules without histopathologic follow-up were not reported. SHCN: suspicious for Hürthle cell neoplasm. TN: true negative. TP: true positive.
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