PDF(Pubmed)
Abstract：
Molecular tests are being used increasingly as an auxiliary diagnostic tool so as to avoid a diagnostic surgery approach for cytologically indeterminate thyroid nodules (ITNs). Previous test versions, Thyroseq v2 and Afirma Gene Expression Classifier (GEC), have proven shortcomings in malignancy detection performance.
This study aimed to evaluate the diagnostic performance of the established Thyroseq v3, Afirma Gene Sequencing Classifier (GSC), and microRNA-based assays versus prior iterations in ITNs, in light of \"rule-in\" and \"rule-out\" concepts. It further analyzed the impact of noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) reclassification and Bethesda cytological subtypes on the performance of molecular tests.
Pubmed, Scopus, and Web of Science were the databases used for the present research, a process that lasted until September 2020. A random-effects bivariate model was used to estimate the summary sensitivity, specificity, positive (PLR) and negative likelihood ratios (NLR), and area under the curve (AUC) for each panel. The conducted sensitivity analyses addressed different Bethesda categories and NIFTP thresholds.
A total of 40 eligible studies were included with 7,831 ITNs from 7,565 patients. Thyroseq v3 showed the best overall performance (AUC 0.95; 95% confidence interval: 0.93-0.97), followed by Afirma GSC (AUC 0.90; 0.87-0.92) and Thyroseq v2 (AUC 0.88; 0.85-0.90). In terms of \"rule-out\" abilities Thyroseq v3 (NLR 0.02; 95%CI: 0.0-2.69) surpassed Afirma GEC (NLR 0.18; 95%CI: 0.10-0.33). Thyroseq v2 (PLR 3.5; 95%CI: 2.2-5.5) and Thyroseq v3 (PLR 2.8; 95%CI: 1.2-6.3) achieved superior \"rule-in\" properties compared to Afirma GSC (PLR 1.9; 95%CI: 1.3-2.8). Evidence for Thyroseq v3 seems to have higher quality, notwithstanding the paucity of studies. Both Afirma GEC and Thyroseq v2 performance have been affected by NIFTP reclassification. ThyGenNEXT/ThyraMIR and RosettaGX show prominent preliminary results.
The newly emerged tests, Thyroseq v3 and Afirma GSC, designed for a \"rule-in\" purpose, have been proved to outperform in abilities to rule out malignancy, thus surpassing previous tests no longer available, Thyroseq 2 and Afirma GEC. However, Thyroseq v2 still ranks as the best rule-in molecular test.
http://www.crd.york.ac.uk/PROSPERO, identifier CRD42020212531.
This study aimed to evaluate the diagnostic performance of the established Thyroseq v3, Afirma Gene Sequencing Classifier (GSC), and microRNA-based assays versus prior iterations in ITNs, in light of \"rule-in\" and \"rule-out\" concepts. It further analyzed the impact of noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP) reclassification and Bethesda cytological subtypes on the performance of molecular tests.
Pubmed, Scopus, and Web of Science were the databases used for the present research, a process that lasted until September 2020. A random-effects bivariate model was used to estimate the summary sensitivity, specificity, positive (PLR) and negative likelihood ratios (NLR), and area under the curve (AUC) for each panel. The conducted sensitivity analyses addressed different Bethesda categories and NIFTP thresholds.
A total of 40 eligible studies were included with 7,831 ITNs from 7,565 patients. Thyroseq v3 showed the best overall performance (AUC 0.95; 95% confidence interval: 0.93-0.97), followed by Afirma GSC (AUC 0.90; 0.87-0.92) and Thyroseq v2 (AUC 0.88; 0.85-0.90). In terms of \"rule-out\" abilities Thyroseq v3 (NLR 0.02; 95%CI: 0.0-2.69) surpassed Afirma GEC (NLR 0.18; 95%CI: 0.10-0.33). Thyroseq v2 (PLR 3.5; 95%CI: 2.2-5.5) and Thyroseq v3 (PLR 2.8; 95%CI: 1.2-6.3) achieved superior \"rule-in\" properties compared to Afirma GSC (PLR 1.9; 95%CI: 1.3-2.8). Evidence for Thyroseq v3 seems to have higher quality, notwithstanding the paucity of studies. Both Afirma GEC and Thyroseq v2 performance have been affected by NIFTP reclassification. ThyGenNEXT/ThyraMIR and RosettaGX show prominent preliminary results.
The newly emerged tests, Thyroseq v3 and Afirma GSC, designed for a \"rule-in\" purpose, have been proved to outperform in abilities to rule out malignancy, thus surpassing previous tests no longer available, Thyroseq 2 and Afirma GEC. However, Thyroseq v2 still ranks as the best rule-in molecular test.
http://www.crd.york.ac.uk/PROSPERO, identifier CRD42020212531.
摘要：
分子测试越来越多地用作辅助诊断工具，以避免对细胞学上不确定的甲状腺结节（ITN）进行诊断性手术方法。以前的测试版本，Thyryroseqv2和Afirma基因表达分类器（GEC），在恶性肿瘤检测性能方面已经证明了缺点。
本研究旨在评估已建立的Thyroseqv3，Afirma基因测序分类器（GSC）的诊断性能，和基于microRNA的测定与ITN中的先前迭代，根据“rule-in”和“rule-out”概念。它进一步分析了具有乳头状样细胞核特征（NIFTP）的非侵入性滤泡性甲状腺肿瘤重新分类和Bethesda细胞学亚型对分子测试性能的影响。
已发布，Scopus,和WebofScience是本研究使用的数据库，这一过程一直持续到2020年9月。使用随机效应双变量模型来估计汇总灵敏度，特异性，正(PLR)和负似然比(NLR)，和每个面板的曲线下面积(AUC)。所进行的敏感性分析针对不同的Bethesda类别和NIFTP阈值。
共有40项符合条件的研究纳入了7,565名患者的7,831项ITN。Thyroseqv3显示出最佳的整体性能（AUC0.95；95％置信区间：0.93-0.97），其次是AfirmaGSC（AUC0.90;0.87-0.92）和Thyroseqv2（AUC0.88;0.85-0.90）。就“排除”能力而言，Thyroseqv3（NLR0.02；95CI：0.0-2.69）超过了AfirmaGEC（NLR0.18；95CI：0.10-0.33）。与AfirmaGSC（PLR1.9；95CI：1.3-2.8）相比，Thyryroseqv2（PLR3.5；95CI：2.2-5.5）和Thyryroseqv3（PLR2.8；95CI：1.2-6.3）具有优越的“规则”性能。Thyroseqv3的证据似乎质量更高，尽管研究很少。AfirmaGEC和Thyroseqv2性能均受到NIFTP重新分类的影响。ThyGenNEXT/ThyraMIR和RosettaGX显示出突出的初步结果。
新出现的测试，Thyroseqv3和AfirmaGSC，专为“规则适用”而设计，已经被证明在排除恶性肿瘤的能力方面表现出色，因此超过了以前不再可用的测试，Thyryroseq2和AfirmaGEC。然而,Thyroseqv2仍然是分子测试中的最佳规则。
http://www。crd.约克。AC.英国/PROSPERO,标识符CRD42020212531。
本研究旨在评估已建立的Thyroseqv3，Afirma基因测序分类器（GSC）的诊断性能，和基于microRNA的测定与ITN中的先前迭代，根据“rule-in”和“rule-out”概念。它进一步分析了具有乳头状样细胞核特征（NIFTP）的非侵入性滤泡性甲状腺肿瘤重新分类和Bethesda细胞学亚型对分子测试性能的影响。
已发布，Scopus,和WebofScience是本研究使用的数据库，这一过程一直持续到2020年9月。使用随机效应双变量模型来估计汇总灵敏度，特异性，正(PLR)和负似然比(NLR)，和每个面板的曲线下面积(AUC)。所进行的敏感性分析针对不同的Bethesda类别和NIFTP阈值。
共有40项符合条件的研究纳入了7,565名患者的7,831项ITN。Thyroseqv3显示出最佳的整体性能（AUC0.95；95％置信区间：0.93-0.97），其次是AfirmaGSC（AUC0.90;0.87-0.92）和Thyroseqv2（AUC0.88;0.85-0.90）。就“排除”能力而言，Thyroseqv3（NLR0.02；95CI：0.0-2.69）超过了AfirmaGEC（NLR0.18；95CI：0.10-0.33）。与AfirmaGSC（PLR1.9；95CI：1.3-2.8）相比，Thyryroseqv2（PLR3.5；95CI：2.2-5.5）和Thyryroseqv3（PLR2.8；95CI：1.2-6.3）具有优越的“规则”性能。Thyroseqv3的证据似乎质量更高，尽管研究很少。AfirmaGEC和Thyroseqv2性能均受到NIFTP重新分类的影响。ThyGenNEXT/ThyraMIR和RosettaGX显示出突出的初步结果。
新出现的测试，Thyroseqv3和AfirmaGSC，专为“规则适用”而设计，已经被证明在排除恶性肿瘤的能力方面表现出色，因此超过了以前不再可用的测试，Thyryroseq2和AfirmaGEC。然而,Thyroseqv2仍然是分子测试中的最佳规则。
http://www。crd.约克。AC.英国/PROSPERO,标识符CRD42020212531。
